Autism Spectrum Disorder
Conditions
Keywords
NDBI, Autism
Brief summary
Naturalistic Developmental Behavioral Interventions (NDBIs), an evidence-based early autism spectrum disorder (ASD) intervention approach, target key behaviors that help language development. While efforts to use NDBIs are increasing worldwide, important gaps in our knowledge remain on whether the behaviors targeted by NDBIs are cross-culturally valid. This study in South Africa, a multi-cultural setting, will provide critical information on NDBI treatment targets and a novel digital outcome measure of treatment response. COVID-19 adaptations: We aim to develop and implement telehealth NDBI coaching and utilize a mixed methods approach to gather implementation and preliminary effectiveness data on the telehealth intervention.
Detailed description
COVID-19 has significantly impacted autism spectrum disorder (ASD) clinical research and disrupted access to intervention services for children and families globally. In this ongoing study in Cape Town South Africa, a caregiver coaching Naturalistic Developmental Behavioral Intervention (NDBI) for young children with ASD has been adapted for implementation by non-specialists and implementation and clinical outcomes are being evaluated. For ongoing clinical trials, the University of Cape Town Institutional Review Board (IRB) has encouraged researchers to switch to a virtual platform, where possible. Telehealth caregiver coaching is cost-effective, increases access to rural and underserved populations, and improves understanding of family home and caregiving routines. We aim to develop and implement telehealth NDBI coaching and utilize a mixed methods approach and a longitudinal pre-post design to gather implementation and preliminary effectiveness data on the telehealth intervention.
Interventions
BEHAVIORALEarly Start Denver Model (ESDM)
Twelve one hour sessions, skill is introduced by Help is in your hands Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. Help is in your hands Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid.
BEHAVIORALTelehealth coaching
The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist.
Sponsors
University of Cape Town
National Institute of Mental Health (NIMH)
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Note the autism group will be the only group to receive intervention. The typically developing and developmental delay group will receive one baseline assessment, and no intervention. COVID-19 necessitated a pivot from in-person to telehealth coaching.
Eligibility
Sex/Gender
ALL
Age
18 Months to 72 Months
Healthy volunteers
Yes
Inclusion criteria
1. For ASD, DD, TD groups * Subject family speaks isiXhosa, Afrikaans, or English * Child's ethnicity/race is African or Coloured (A South African term for individuals with mixed racial heritage) * Child lives within an area served by the recruitment sites 2. For the ASD group only: * Child meets criteria for an ASD diagnosis based upon DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria and informed by the ADOS-2 (Autism Diagnostic Observation Schedule) administered by research reliable raters * Caregiver is at least 18 years old 3. For the developmental delay (DD) group only: * Child screens positive on the Ten Questions and negative for ASD on the ABC * Child has been diagnosed with developmental delay by a developmental pediatrician 4. For the typically developing (TD) group only: -Child screens negative on the Ten Questions and negative for ASD on the ABC 5. For the Early Childhood Development (ECD) Practitioners and Early Childhood Development Practitioner School Supervisors group: * Employed by participating recruitment partners (Western Cape Education Department Schools) * Involved in delivery of the caregiver coaching sessions, either in person or remotely 6. For the Early Start Denver Model (ESDM) supervisors group: * Trained ESDM therapist * Supervise weekly coaching sessions in the schools, and/or * Supervise remote intervention delivery sessions
Exclusion criteria
1. For all groups (ASD, DD, TD) * Significant sensory or motor impairment * Major physical abnormalities * History of serious head injury and/or neurological disease 2. For the ASD group: * Presence of a neurological disorder of known etiology (for e.g., Downs Syndrome) * Caregiver-child dyad unable to attend assessments and 12 coaching sessions 3. For the developmental delay (DD) group -Autism diagnosis based on DSM 5 criteria 4. For typically developing (TD group: * Autism diagnosis based on DSM 5 criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Baseline and Follow up (after 12 intervention sessions, up to 3 months) | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Communication subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior. |
| Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. |
| Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. |
| Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) | Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language. |
| Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS) | Baseline | Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for initiation of joint attention (IJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention. |
| Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS) | Baseline | Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for response to joint attention (RJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. RJA score ranges from 0 to 20 where a higher value indicates greater response to joint attention. |
| Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Baseline and Follow up (after 12 intervention sessions, up to 3 months) | The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) \*100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age. |
| Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Baseline and Follow up (after 12 intervention sessions, up to 3 months) | The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) \*100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age. |
| Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Baseline and Follow up (after 12 intervention sessions, up to 3 months) | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Socialization subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior. |
| Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) ; in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. |
| Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. |
| Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) | Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement. |
| Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) | Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth. |
| Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Baseline and Follow-up (after 12 intervention sessions, up to 3 months) | Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM) | Follow-up (within 2 weeks of ending sessions) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater appropriateness. |
| Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM) | Follow-up (within 2 weeks of ending sessions) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater feasibility. |
| Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System | Baseline and Follow-up (up to 4 months) | ESDM Fidelity Rating System uses a 13 item rating scale that includes ratings of performance on core intervention strategies from 1 to 5 (1 represents a lack of an effective display of the practices specified, and 5 represents the best possible example of this teaching behavior). Fidelity of implementation of Naturalistic Developmental Behavioral Intervention (NDBI) strategies will be manually coded by certified ESDM therapists. Mean fidelity scores (with SD) will be calculated across study participants in order to assess change in NDBI strategies. ESDM Fidelity Rating System scores range from 0 to 100 with a higher score reflecting interactions closer to ESDM principles. |
| Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM) | Follow-up (within 2 weeks of ending sessions) | A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1 - 5 with higher scores indicating greater acceptability. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postural Sway Measured by the SenseToKnow App | Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). |
| Social Referencing Measured by the SenseToKnow App | Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). |
| Affective Response Measured by the SenseToKnow App | Baseline and fBaseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). |
| Gaze Patterns Measured by the SenseToKnow App | Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group | SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name). |
Countries
South Africa
Participant flow
Recruitment details
ASD caregiver-child dyads were recruited from Western Cape Department of Education Autism Schools; children with developmental delay from Neurodevelopmental Clinics at Red Cross Children's Hospital; typically developing children from ECD Centers. ASD caregiver-child dyads could opt to continue with Telehealth intervention when COVID restrictions were implemented. Participants recruited March 2020-March 2021 received telehealth intervention.
Pre-assignment details
One participant from the Children with Typical Development group was deemed ineligible post-enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Caregivers Participants in this arm will be caregivers of children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by Help is in your hands Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. Help is in your hands Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. | 17 |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Children Participants in this arm will be children with ASD. Early Start Denver Model (ESDM): Twelve one hour sessions, skill is introduced by Help is in your hands Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. Help is in your hands Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid. | 17 |
| Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Caregivers Participants in this arm will be caregivers of children with ASD who began the intervention in-person and moved to telehealth due to COVID-19 restrictions.
In-person: Twelve 1-hour sessions, skill is introduced by Help is in your hands Community Early Start Denver Model (C-ESDM) videos. Skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. The ECD practitioner then coaches the caregiver in at least two activities. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill using a daily activities visual aid.
Telehealth coaching: The telehealth coaching intervention was informed by the C-ESDM materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached as above (via phone). Prior to the coaching session staff shared session materials with the family via WhatsApp and the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. | 2 |
| Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Children Participants in this arm will be children with ASD who began the intervention in-person and moved to telehealth due to COVID-19 restrictions.
In-person: Twelve 1-hour sessions, skill is introduced by Help is in your hands Community Early Start Denver Model (C-ESDM) videos. Skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. The ECD practitioner then coaches the caregiver in at least two activities. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill using a daily activities visual aid.
Telehealth coaching: The telehealth coaching intervention was informed by the C-ESDM materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached as above (via phone). Prior to the coaching session staff shared session materials with the family via WhatsApp and the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. | 2 |
| Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Caregivers Participants in this arm will be caregivers of children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions).
Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. | 12 |
| Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Children Participants in this arm will be children with ASD receiving telehealth intervention (adaptation due to COVID-19 restrictions).
Telehealth coaching: The telehealth coaching intervention was informed by the Community-Early Start Denver Model (C-ESDM) materials. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) were developed by the research team. Over 12, 1-hour asynchronous caregiver coaching sessions that are delivered by non-specialists, caregivers were coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors. The session itself being delivered via phone. Prior to the coaching session staff shared session materials with the family via WhatsApp. Prior to the session the caregiver shared a 6-min video of an interaction with their child. During the session, the caregiver and coach reviewed the video, and the caregiver completed a self-reflection checklist. | 12 |
| Children With Typical Development Participants in this arm will be children with typical development. No intervention. | 2 |
| Children With Developmental Delay Participants in this arm will be children with developmental delay. No intervention. | 1 |
| Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors The ECD worker and/or school supervisor are 1) employed by our participating recruitment partners (Western Cape Education Department Schools) and 2) involved in delivery of the caregiver coaching sessions, either in person or remotely. | 4 |
| Early Start Denver Model (ESDM) Supervisors The local supervisors are 1) trained ESDM therapist, 2) supervise weekly coaching sessions in the schools, and/or 3) supervise remote intervention delivery sessions. | 3 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 | 5 | 5 | 0 | 0 | 1 | 0 |
| Overall Study | Unable to complete intervention due to COVID-19 restrictions | 7 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Caregivers | Total | Children With Developmental Delay | Children With Typical Development | Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Children | Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Children | Caregiver-Child Dyads With ASD (In-person Intervention ONLY) - Children | Caregiver-Child Dyads With ASD (Telehealth Intervention ONLY) - Caregivers | Caregiver-Child Dyads With ASD (In-person, Then Telehealth Intervention) - Caregivers | Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors | Early Start Denver Model (ESDM) Supervisors |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.12 years STANDARD_DEVIATION 9.6 | 35.92 years STANDARD_DEVIATION 8.56 | 18 months STANDARD_DEVIATION 0 | 41 months STANDARD_DEVIATION 7.07 | 51.25 months STANDARD_DEVIATION 16.94 | 40.5 months STANDARD_DEVIATION 17.68 | 50.19 months STANDARD_DEVIATION 9.66 | 35.5 years STANDARD_DEVIATION 7.52 | 36 years STANDARD_DEVIATION 7.07 | — | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 72 Participants | 1 Participants | 2 Participants | 12 Participants | 2 Participants | 17 Participants | 12 Participants | 2 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 16 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 5 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 37 Participants | 0 Participants | 1 Participants | 7 Participants | 0 Participants | 10 Participants | 7 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 14 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Region of Enrollment South Africa | 17 Participants | 72 Participants | 1 Participants | 2 Participants | 12 Participants | 2 Participants | 17 Participants | 12 Participants | 2 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 11 Participants | 37 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 10 Participants | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 35 Participants | 0 Participants | 1 Participants | 10 Participants | 1 Participants | 14 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 2 | 0 / 2 | 0 / 12 | 0 / 12 | 0 / 2 | 0 / 1 | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 17 | 0 / 17 | 0 / 2 | 0 / 2 | 0 / 12 | 0 / 12 | 0 / 2 | 0 / 1 | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 2 | 0 / 2 | 0 / 12 | 0 / 12 | 0 / 2 | 0 / 1 | 0 / 4 | 0 / 3 |
Outcome results
Primary
Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI)
Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language.
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 4 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 4.5 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 5 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 5 score on a scale |
| Children With Typical Development | Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 5 score on a scale |
| Children With Developmental Delay | Caregiver Affect Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 3 score on a scale |
Primary
Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)
The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Communication subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior.
Time frame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to the Caregiver-Child Dyads With ASD groups.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Baseline | 41 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Follow-up | 50 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Baseline | 34 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Communication Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Follow-up | 40 score on a scale |
p-value: 0.011Wilcoxon (Mann-Whitney)
p-value: 0.049Wilcoxon (Mann-Whitney)
Primary
Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement.
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 1 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 1 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 1 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 1 score on a scale |
| Children With Typical Development | Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 6 score on a scale |
| Children With Developmental Delay | Coordinated Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 2 score on a scale |
p-value: 0.655Wilcoxon (Mann-Whitney)
p-value: 0.564Wilcoxon (Mann-Whitney)
Primary
Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI)
Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth.
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 4 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 5 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 4 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 5 score on a scale |
| Children With Typical Development | Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 6 score on a scale |
| Children With Developmental Delay | Fluency and Connectedness Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 3 score on a scale |
p-value: 0.096Wilcoxon (Mann-Whitney)
p-value: 0.732Wilcoxon (Mann-Whitney)
Primary
Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI)
Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language.
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 5 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 6 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 5 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 5 score on a scale |
| Children With Typical Development | Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 5 score on a scale |
| Children With Developmental Delay | Following in on a Child's Focus Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 2 score on a scale |
p-value: 0.35Wilcoxon (Mann-Whitney)
p-value: 0.68Wilcoxon (Mann-Whitney)
Primary
Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS)
Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for initiation of joint attention (IJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. IJA score ranges from 0 to 100 where a higher value indicates greater initiation of joint attention.
Time frame: Baseline
Population: Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. This measure was introduced later in the study and therefore not administered to all participants. Data not collected on the Caregiver-Child Dyads With ASD (Telehealth Intervention) group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS) | 8.33 score on a scale |
| Children With Typical Development | Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS) | 69 score on a scale |
| Children With Developmental Delay | Initiation of Joint Attention (IJA) Measured by the Early Social Communication Scales (ESCS) | 27 score on a scale |
Primary
Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)
The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) \*100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age.
Time frame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to child groups. Data not collected on Caregiver-Child Dyads With ASD (Telehealth Intervention) - Children group. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Baseline | 57.73 units on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Follow-up | 62.24 units on a scale |
| Children With Typical Development | Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Baseline | 114 units on a scale |
| Children With Developmental Delay | Language and Communication Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Baseline | 50 units on a scale |
p-value: 0.004Wilcoxon (Mann-Whitney)
Primary
Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III)
The Griffiths Scales of Child Development, Third Edition (Griffiths III) is a comprehensive, developmental measure for continuous use from birth to 5 years 11 months (71 months). Although not standardized in South Africa (standardization samples are from the United Kingdom and Ireland), this developmental assessment is widely used in South Africa. The Griffiths III provides an overall measure of a child's development, as well as an individual profile of strengths and needs across five areas: Foundations of Learning; Language and Communication; Eye and Hand Coordination; Personal-Social-Emotional; and Gross Motor. Developmental quotients (DQs) were calculated by (Developmental Age/Chronological Age) \*100. Griffiths III DQs range from 1 to 100 where higher scores indicate that the child performs at or near expected chronological age as compared with a normative sample of children the same age.
Time frame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to child groups. Data not collected on Caregiver-Child Dyads With ASD (Telehealth Intervention) - Children group. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Baseline | 63.41 units on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Follow-up | 65.53 units on a scale |
| Children With Typical Development | Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Baseline | 115 units on a scale |
| Children With Developmental Delay | Personal-Social-Emotional Developmental Quotient on the Griffiths Scales of Child Development 3rd Edition (Griffiths-III) | Baseline | 83.33 units on a scale |
p-value: 0.084Wilcoxon (Mann-Whitney)
Primary
Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS)
Joint attention skills will be measured using the Early Social Communication Scales (ESCS) in the ASD group; the typically developing group; and the developmental delay group. The ESCS assesses nonverbal communication skills, is normed for typically developing children 18 to 30 months of age in addition to children with developmental delay expressive language level is in approximately the same range. Frequency scores for response to joint attention (RJA) will be derived from behavioral observations during a series of tasks presented by an examiner blind to child diagnosis. RJA score ranges from 0 to 20 where a higher value indicates greater response to joint attention.
Time frame: Baseline
Population: Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. This measure was introduced later in the study and therefore not administered to all participants. Data not collected on the Caregiver-Child Dyads With ASD (Telehealth Intervention) group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS) | 5 score on a scale |
| Children With Typical Development | Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS) | 15 score on a scale |
| Children With Developmental Delay | Response to Joint Attention (RJA) Measured by the Early Social Communication Scales (ESCS) | 7 score on a scale |
Primary
Scaffolding Measured by the Joint Engagement Rating Inventory (JERI)
Caregiver strategies measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates that the caregiver rarely uses the caregiver strategy to support the child's activity and language. A rating of 7 indicates that the caregiver frequently uses appropriate strategies to support and expand their child's activity and language.
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 5 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 5 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 4 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 4 score on a scale |
| Children With Typical Development | Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 5 score on a scale |
| Children With Developmental Delay | Scaffolding Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 2 score on a scale |
p-value: 0.442Wilcoxon (Mann-Whitney)
p-value: 0.458Wilcoxon (Mann-Whitney)
Primary
Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI)
Caregiver-child dyadic exchanges measured by the Joint Engagement Rating Inventory (JERI) in the ASD group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates no interaction between the dyad, a rating of 7 indicates a balanced dyadic exchange that flows naturally back and forth.
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 1 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 1 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 1 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 1 score on a scale |
| Children With Typical Development | Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 1 score on a scale |
| Children With Developmental Delay | Shared Routines and Rituals Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 1 score on a scale |
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 0.705Wilcoxon (Mann-Whitney)
Primary
Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3)
The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is an individually-administered measure of adaptive behavior that is widely used to assess individuals with intellectual, developmental, and other disabilities. The Vineland-3 contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior. The Caregiver Interview Form uses the Vineland semistructured interview technique to elicit information about the examinee's adaptive functioning from a parent or caregiver. Item responses are collected on a 3-point Likert scale with values representing 0 (never), 1 (sometimes), and 2 (usually or often) to capture frequency of target behavior. Some items require binary responses (yes/no). The VABS-3 Socialization subscale score ranges from 20-140 where a higher score indicates greater frequency of target behavior.
Time frame: Baseline and Follow up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to the Caregiver-Child Dyads With ASD groups.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Baseline | 61 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Follow-up | 67.5 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Baseline | 63 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Socialization Subscale Standard Score on the Vineland Adaptive Behavior Scales - 3rd Edition (VABS-3) | Follow-up | 61 score on a scale |
p-value: 0.42Wilcoxon (Mann-Whitney)
p-value: 0.171Wilcoxon (Mann-Whitney)
Primary
Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
Child engagement states measured by the Joint Engagement Rating Inventory (JERI) ; in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement.
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 6 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 5.5 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 4 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 5 score on a scale |
| Children With Typical Development | Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 2 score on a scale |
| Children With Developmental Delay | Supported Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 4 score on a scale |
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 0.914Wilcoxon (Mann-Whitney)
Primary
Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI)
Child engagement states measured by the Joint Engagement Rating Inventory (JERI) in the ASD group; the typically developing group; and the developmental delay group. Joint Engagement Rating Inventory contains eighteen 7-point Likert scale items that characterized various aspects of joint engagement. The items were designed to span the range of possibilities likely to be observed during interactions with 18- to 30-month-old TD children as well as similarly aged and older children with developmental difficulties, including ASD. A rating of 1 indicates a very low rating and no time spent in that engagement state, 4 is the midpoint indicating the moderate time and quality of episodes in an engagement state, and 7 indicates a very high rating and high-quality engagement.
Time frame: Baseline and Follow-up (after 12 intervention sessions, up to 3 months)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD, Children with typical development, and Children with developmental delay groups. Data only collected at baseline for Children with Typical Development and Children with Developmental Delay.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 2 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 3 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 2 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Follow-up | 1 score on a scale |
| Children With Typical Development | Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 6.5 score on a scale |
| Children With Developmental Delay | Symbol-infused Joint Engagement Measured by the Joint Engagement Rating Inventory (JERI) | Baseline | 2 score on a scale |
p-value: 0.705Wilcoxon (Mann-Whitney)
p-value: 0.014Wilcoxon (Mann-Whitney)
Secondary
Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM)
A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1 - 5 with higher scores indicating greater acceptability.
Time frame: Follow-up (within 2 weeks of ending sessions)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD (Telehealth Intervention) - Caregivers, Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors, and Early Start Denver Model (ESDM) Supervisors groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM) | 4.25 score on a scale | Standard Deviation 0.4 |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM) | 4.66 score on a scale | Standard Deviation 0.6 |
| Children With Typical Development | Acceptability of Telehealth Intervention (as Measured by the Acceptability of Intervention Measure, AIM) | 4.78 score on a scale | Standard Deviation 0.1 |
Secondary
Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM)
A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater appropriateness.
Time frame: Follow-up (within 2 weeks of ending sessions)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD (Telehealth Intervention) - Caregivers, Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors, and Early Start Denver Model (ESDM) Supervisors groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM) | 4.47 score on a scale | Standard Deviation 0.4 |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM) | 4.66 score on a scale | Standard Deviation 0.6 |
| Children With Typical Development | Appropriateness of Telehealth Intervention (as Measured by the Intervention Appropriateness Measure, IAM) | 4.66 score on a scale | Standard Deviation 0.8 |
Secondary
Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM)
A 5-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scores are indicated on a scale of 1-5 with higher scores indicating greater feasibility.
Time frame: Follow-up (within 2 weeks of ending sessions)
Population: Participants who completed the study. Only applicable to Caregiver-Child Dyads With ASD (Telehealth Intervention) - Caregivers, Early Childhood Development (ECD) Practitioners and ECD Practitioner School Supervisors, and Early Start Denver Model (ESDM) Supervisors groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM) | 4.14 score on a scale | Standard Deviation 0.4 |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM) | 4.66 score on a scale | Standard Deviation 0.6 |
| Children With Typical Development | Feasibility of Intervention (as Measured by the Feasibility of Intervention Measure, FIM) | 4.9 score on a scale | Standard Deviation 0.1 |
Secondary
Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System
ESDM Fidelity Rating System uses a 13 item rating scale that includes ratings of performance on core intervention strategies from 1 to 5 (1 represents a lack of an effective display of the practices specified, and 5 represents the best possible example of this teaching behavior). Fidelity of implementation of Naturalistic Developmental Behavioral Intervention (NDBI) strategies will be manually coded by certified ESDM therapists. Mean fidelity scores (with SD) will be calculated across study participants in order to assess change in NDBI strategies. ESDM Fidelity Rating System scores range from 0 to 100 with a higher score reflecting interactions closer to ESDM principles.
Time frame: Baseline and Follow-up (up to 4 months)
Population: Participants who completed the study. Only applicable to the Caregiver-Child Dyads With ASD Caregiver groups.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System | Baseline | 60 score on a scale |
| Caregiver-Child Dyads With ASD (In-person Intervention ONLY) | Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System | Follow-up | 75 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System | Baseline | 55 score on a scale |
| Caregiver-Child Dyads With ASD (Telehealth Intervention) | Fidelity of Intervention Delivery, as Measured by the Caregiver ESDM Fidelity Rating System | Follow-up | 68 score on a scale |
p-value: 0.003Wilcoxon (Mann-Whitney)
p-value: 0.139Wilcoxon (Mann-Whitney)
Other Pre-specified
Affective Response Measured by the SenseToKnow App
SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name).
Time frame: Baseline and fBaseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
Other Pre-specified
Gaze Patterns Measured by the SenseToKnow App
SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name).
Time frame: Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
Other Pre-specified
Postural Sway Measured by the SenseToKnow App
SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name).
Time frame: Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group
Other Pre-specified
Social Referencing Measured by the SenseToKnow App
SenseToKnow is an app developed for mobile devices that is designed to elicit autism risk behaviors. In order to administer the app, children sit on the parent's lap with the mobile device at eye level for the child. The app is comprised of a set of stimuli (videos and games) that are designed to elicit autism spectrum disorder (ASD) symptoms, such as facial expressions. Multi-modal time-series video-frame-level data streams from the computer vision analysis output of SenseToKnow will be summarized with descriptive statistics and visualizations. We extract landmarks and determine the correct features from them to yield precise measurements of attention, gaze, affect, and posture. Each computer vision analysis feature will be transformed into one or more binary, count, or continuous participant-level summary variable (for e.g. number of times orienting to name).
Time frame: Baseline and Baseline and Follow up (after 12 intervention sessions, up to 3 months) ASD group; Baseline typically developing and developmental delay group