Autism Spectrum Disorder
Conditions
Brief summary
The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 4 after their initial diagnosis of autism. The main questions it aims to answer are: Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism? Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism? Does Family Navigation improve caregiver well-being? Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.
Interventions
BEHAVIORALVirtual Family Navigation
Participants randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.
BEHAVIORALEducational Materials
The comparison condition ("Educational Materials") consists of providing the participant's caregivers information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling.
Sponsors
University of North Carolina, Chapel Hill
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Children up to 48 months who have a new diagnosis of autism, or who are waiting for a diagnosis of autism AND their caregiver. * Live in Georgia or North Carolina * Caregiver must be over the age of 18 * Their child with autism must identify as Black/African-American * Speak conversationally fluent English.
Exclusion criteria
* No access to a telephone or internet connection for phone calls or video conferencing. * Diagnosis of autism spectrum disorder is ruled out in the child.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Initiation of Autism Specific Intervention | From enrollment up to 6 months post | The date of initiation (date 2) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 1). Time will be calculated as the number of days elapsed between these two dates (date 2 - date 1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Well-Being Score | 6 months post enrollment | Scores on the General Well-Being Schedule will be used to measure caregiver well-being. Total scores range from 0-110. Higher scores are indicative of more positive well-being. There are 3 proposed scoring cut-points: 0-60 reflects "severe distress", 61-72 reflects "moderate distress", and 73-110 reflects "positive well-being). |
| Child's Developmental Functioning Score | 18 months post enrollment | The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance. |
| Child's Adaptive Functioning Score | 18 months post enrollment | The Adaptive Behavior Assessment Scale, Third Edition (ABAS-3) will be used to measure adaptive functioning. The ABAS-3 assesses 3 domains of adaptive behavior, including Conceptual, Social, and Practical. The General Adaptive Composite (GAC) is a composite score derived from the 4 domains. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger adaptive behavior skills. |
| Appropriateness of Intervention Score | 6 months after enrollment | The Intervention Appropriateness Measure (IAM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's appropriateness. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. |
| Feasibility of Intervention Score | 6 months after enrollment | The Feasibility of Intervention Measure (FIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's feasibility. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. |
| Acceptability of Intervention Score | 6 months after enrollment | The Acceptability of Intervention Measure (AIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's acceptability. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKelly Caravella, PhD
UNC
Participant flow
Pre-assignment details
Of the 33 participants (16 Family Units \[FU\]) who met initial eligibility and signed informed consent, 31 participants (15 FUs) completed Baseline and remained eligible for randomization. Of those eligible, 6 participants (3 FUs) did not continue following randomization and did not receive any exposure to a study intervention. Data are reported below for the 25 participants (12 FUs) exposed to a study intervention.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical Caregivers <=18 years | 0 Participants |
| Age, Categorical Caregivers >=65 years | 0 Participants |
| Age, Categorical Caregivers Between 18 and 65 years | 13 Participants |
| Age, Categorical Children <=18 years | 12 Participants |
| Age, Categorical Children >=65 years | 0 Participants |
| Age, Categorical Children Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Children Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Children Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Children Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 0 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 6 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregivers White | 0 Participants |
| Race (NIH/OMB) Children American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Children Asian | 0 Participants |
| Race (NIH/OMB) Children Black or African American | 11 Participants |
| Race (NIH/OMB) Children More than one race | 1 Participants |
| Race (NIH/OMB) Children Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Children Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Children White | 0 Participants |
| Region of Enrollment United States Caregivers | 7 Participants |
| Region of Enrollment United States Children | 6 Participants |
| Sex: Female, Male Caregivers Female | 12 Participants |
| Sex: Female, Male Caregivers Male | 1 Participants |
| Sex: Female, Male Children Female | 8 Participants |
| Sex: Female, Male Children Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
None listed