Autism Spectrum Disorder
Conditions
Brief summary
Our pilot study will address a number of pressing questions, including: Can community clinicians successfully coach parents of children with ASD in evidence-based practice to achieve positive outcomes for their children and themselves? What dose is necessary to achieve change? And what is the cost effectiveness of implementing evidence-based interventions at different doses?
Detailed description
The investigators will partner with 6 of Philadelphias 13 agencies serving young children with ASD. The investigators will enroll 3 clinicians per agency (18 total) and 3 families per clinician (54 total). Agencies will be randomized to the 3 arms. The investigators will measure clinician fidelity and parent fidelity through direct observation and selfreport. The investigators will measure child and parent outcomes at baseline and 6 months using measures common to similar trials. Resource use for the economic evaluation will occur quarterly and will take a societal approach. The investigators will partner with a community advisory board to apply the findings from this pilot trial to the development of a larger, system-wide subsequent trial that is feasible and ecologically valid for Philadelphias EI system. The results will provide rigorous information about whether evidence-based autism interventions for young children can be implemented successfully with the resources available in cities like Philadelphia, the role of hours of treatment in improving child outcomes, and the cost-benefit implications for families and community agencies. This project has the potential to dramatically improve the services families of young children with ASD in Philadelphia receive, and significantly improve their long-term outcomes. This preliminary trial would provide the EI system with the information needed to bring this type of intervention to scale across the entire system. It also would serve as the foundation for an application for federal funds to conduct a system-wide study of Project ImPACT as implemented in all Philadelphia agencies serving children with ASD.
Interventions
Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).
Sponsors
Study design
Eligibility
Inclusion criteria
1. child is \<30 months of age (to receive 6 months of intervention) 2. a classification of autism or high autism risk as determined by the EI system; 3. receive early intervention services through the infant and toddler program; and 4. parent is willing to complete the parent measures that are part of this study.
Exclusion criteria
1\) be over 30 months of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain | 6 months | The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Socialization domain is 20-140. Higher scores indicate better outcomes. |
| Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain | Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months. | The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Communication domain is 20-140. Higher scores indicate better outcomes. |
| Brief Observation of Social Communication Change (BOSCC) | Baseline and 6 Month Follow Up (Exit) (6 months) | The BOSCC is a measure of treatment-response for social-communication behaviors. The BOSCC contains 12 items in total. The score range of individual items is 0-5. Items are then summed to a total score. The range for a total score is 0-60. Higher scores are an indication of more symptom severity. |
| Early Intervention Parenting Self-Efficacy Scale (EIPSES) | Baseline and 6 Month Follow Up (6 months) | The EIPSES is a measure of parent self-efficacy. It is a 16-item self-report measure that examines parents beliefs about their ability to produce positive changes and promote optimal development in their child with a disability. Once items are summed, the total score ranges from 16-112, with higher scores indicating better self-efficacy and empowerment. |
| Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) | Collected at Baseline and 6 Month Follow Up (time frame: 6 months) | Parent Responsiveness is measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™). PICCOLO is a checklist of 29 observable developmentally supportive parenting behaviors, with children ages 10-47 months, in four domains (affection, responsiveness, encouragement, and teaching). Each item is scored as 0, 1 or 2. 0 = Behavior absent, not observed 1. = Behavior barely there, sometimes 2. = Behavior seen often Assessors add scores for each item to calculate a domain score and an overall domain score. Total scores can range from 0-58, with higher scores indicating more parent responsiveness to child behavior and actions. |
| Project ImPACT Intervention Fidelity Checklist | 6 months | Parent Treatment Adherence will be assessed through a videotaped parent-child interaction at home. Parent behavior will be scored for use of the intervention strategies using the Project ImPACT Intervention Fidelity Checklist. The scores range from 1 to 5, the higher the score representing the most adherence to the Project ImPACT intervention. The overall score is an average of scores from each item. |
| Project ImPACT Coaching Fidelity Checklist | 3 Month Follow-Up (3 month time frame) | Clinician fidelity is measured using the Project ImPACT Coaching Fidelity Checklist. The checklist measures the providers' use of the core components to Project ImPACT. The form uses a 3-point score (scored from 0-2): 0, Not observed; 1, partially observed; and 2, observed. The final score is a summary percentage rating of overall fidelity with a range of 0-100%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool | 3 Month Follow Up (3 Months) | The PEACE Fidelity Tool measures a provider's caregiver coaching quality by evaluating the quality and use of evidence based caregiver coaching strategies during recorded EI session across 5 domains (collaboration, daily routines, demonstration, practice and feedback, and reflection). The tool consists of 25 items scored on a 5 point scale from 1-5. Domains and total scores are calculated by averaging items. Scores can range from 1-5, with higher scores indicating better coaching competency and quality. |
Countries
United States
Participant flow
Pre-assignment details
Parent/Children dyads were enrolled in the study and counted as 1 family. The total number includes the number of individual parents and children enrolled together as a dyad and individual early intervention providers that were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual: Children The families keep receiving their treatment as usual | 18 |
| Treatment as Usual: Early Interventionists Early interventionists provide treatment and services as usual. | 6 |
| Treatment as Usual: Caregivers The families keep receiving their treatment as usual | 18 |
| ImPACT at a Dose of 1 Hour/Week: Children ImPACT at a dose of 1 hour/week over 6 months
Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI). | 23 |
| ImPACT at a Dose of 1 Hour/Week: Early Interventionists Early Interventionists provide ImPACT at a dose of 1 hour/week over 6 months with at least 3 families on their caseload.
Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI). | 6 |
| ImPACT at a Dose of 1 Hour/Week: Caregivers ImPACT at a dose of 1 hour/week over 6 months
Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI). | 23 |
| ImPACT at 4 Hours/Week: Children ImPACT at 4 hours/week over 6 months.
Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI). | 20 |
| ImPACT at 4 Hours/Week: Early Interventionists Early Interventionists provide ImPACT at a dose of 4 hours/week over 6 months with at least 3 families on their caseload.
Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI). | 6 |
| ImPACT at 4 Hours/Week: Caregivers ImPACT at 4 hours/week over 6 months.
Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI). | 20 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Suspended/Terminated EI Services | 4 | 0 | 4 | 6 | 0 | 6 | 2 | 0 | 2 |
| Overall Study | Switched Agency/Setting | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Children | Treatment as Usual: Early Interventionists | ImPACT at a Dose of 1 Hour/Week: Early Interventionists | ImPACT at a Dose of 1 Hour/Week: Caregivers | ImPACT at 4 Hours/Week: Children | ImPACT at 4 Hours/Week: Early Interventionists | Treatment as Usual: Children | ImPACT at 4 Hours/Week: Caregivers |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 61 Participants | 0 Participants | 23 Participants | 0 Participants | 0 Participants | 0 Participants | 20 Participants | 0 Participants | 18 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 79 Participants | 18 Participants | 0 Participants | 6 Participants | 6 Participants | 23 Participants | 0 Participants | 6 Participants | 0 Participants | 20 Participants |
| Age, Continuous | 10.74 years STANDARD_DEVIATION 16.48 | 28.9 years STANDARD_DEVIATION 5.9 | 1.86 years STANDARD_DEVIATION 0.48 | 42.4 years STANDARD_DEVIATION 9.66 | 42.2 years STANDARD_DEVIATION 9.24 | 32.0 years STANDARD_DEVIATION 7.2 | 2.02 years STANDARD_DEVIATION 0.26 | 39.5 years STANDARD_DEVIATION 8.71 | 1.92 years STANDARD_DEVIATION 0.42 | 35.8 years STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 61 Participants | 6 Participants | 9 Participants | 1 Participants | 3 Participants | 12 Participants | 10 Participants | 2 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 40 Participants | 5 Participants | 7 Participants | 3 Participants | 3 Participants | 6 Participants | 3 Participants | 4 Participants | 5 Participants | 4 Participants |
| Region of Enrollment United States | 140 participants | 18 participants | 23 participants | 6 participants | 6 participants | 23 participants | 20 participants | 6 participants | 18 participants | 20 participants |
| Sex: Female, Male Female | 38 Participants | 0 Participants | 6 Participants | 4 Participants | 6 Participants | 0 Participants | 8 Participants | 6 Participants | 8 Participants | 0 Participants |
| Sex: Female, Male Male | 41 Participants | 0 Participants | 17 Participants | 2 Participants | 0 Participants | 0 Participants | 12 Participants | 0 Participants | 10 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 |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 6 | 0 / 23 | 0 / 6 | 0 / 20 | 0 / 6 | 0 / 18 | 0 / 23 | 0 / 20 |
| other Total, other adverse events | 0 / 18 | 0 / 6 | 0 / 23 | 0 / 6 | 0 / 20 | 0 / 6 | 0 / 18 | 0 / 23 | 0 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 6 | 0 / 23 | 0 / 6 | 0 / 20 | 0 / 6 | 0 / 18 | 0 / 23 | 0 / 20 |
Outcome results
Brief Observation of Social Communication Change (BOSCC)
The BOSCC is a measure of treatment-response for social-communication behaviors. The BOSCC contains 12 items in total. The score range of individual items is 0-5. Items are then summed to a total score. The range for a total score is 0-60. Higher scores are an indication of more symptom severity.
Time frame: Baseline and 6 Month Follow Up (Exit) (6 months)
Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Caregivers, ImPACT at a Dose of 1 Hour/Week: Caregivers, ImPACT at 4 Hours/Week: Caregivers are not included in the analysis as the measure's intent is to assess child outcomes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Brief Observation of Social Communication Change (BOSCC) | Baseline | 35.6 score on a scale | Standard Deviation 29.2 |
| Treatment as Usual | Brief Observation of Social Communication Change (BOSCC) | Follow-Up | 29.2 score on a scale | Standard Deviation 10.3 |
| ImPACT at a Dose of 1 Hour/Week | Brief Observation of Social Communication Change (BOSCC) | Baseline | 36.6 score on a scale | Standard Deviation 8.5 |
| ImPACT at a Dose of 1 Hour/Week | Brief Observation of Social Communication Change (BOSCC) | Follow-Up | 34.8 score on a scale | Standard Deviation 10.3 |
| ImPACT at 4 Hours/Week | Brief Observation of Social Communication Change (BOSCC) | Baseline | 37.0 score on a scale | Standard Deviation 8.8 |
| ImPACT at 4 Hours/Week | Brief Observation of Social Communication Change (BOSCC) | Follow-Up | 36.2 score on a scale | Standard Deviation 5.6 |
Early Intervention Parenting Self-Efficacy Scale (EIPSES)
The EIPSES is a measure of parent self-efficacy. It is a 16-item self-report measure that examines parents beliefs about their ability to produce positive changes and promote optimal development in their child with a disability. Once items are summed, the total score ranges from 16-112, with higher scores indicating better self-efficacy and empowerment.
Time frame: Baseline and 6 Month Follow Up (6 months)
Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Children, ImPACT at a Dose of 1 Hour/Week: Children, ImPACT at 4 Hours/Week: Children are not included in the analysis as the measure's intent is to assess parent outcomes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Early Intervention Parenting Self-Efficacy Scale (EIPSES) | Follow-Up | 87.5 score on a scale | Standard Deviation 9.1 |
| Treatment as Usual | Early Intervention Parenting Self-Efficacy Scale (EIPSES) | Baseline | 87.3 score on a scale | Standard Deviation 9.7 |
| ImPACT at a Dose of 1 Hour/Week | Early Intervention Parenting Self-Efficacy Scale (EIPSES) | Baseline | 84.8 score on a scale | Standard Deviation 9.4 |
| ImPACT at a Dose of 1 Hour/Week | Early Intervention Parenting Self-Efficacy Scale (EIPSES) | Follow-Up | 89.4 score on a scale | Standard Deviation 12.2 |
| ImPACT at 4 Hours/Week | Early Intervention Parenting Self-Efficacy Scale (EIPSES) | Baseline | 87.74 score on a scale | Standard Deviation 6.14 |
| ImPACT at 4 Hours/Week | Early Intervention Parenting Self-Efficacy Scale (EIPSES) | Follow-Up | 89.95 score on a scale | Standard Deviation 9.98 |
Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)
Parent Responsiveness is measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™). PICCOLO is a checklist of 29 observable developmentally supportive parenting behaviors, with children ages 10-47 months, in four domains (affection, responsiveness, encouragement, and teaching). Each item is scored as 0, 1 or 2. 0 = Behavior absent, not observed 1. = Behavior barely there, sometimes 2. = Behavior seen often Assessors add scores for each item to calculate a domain score and an overall domain score. Total scores can range from 0-58, with higher scores indicating more parent responsiveness to child behavior and actions.
Time frame: Collected at Baseline and 6 Month Follow Up (time frame: 6 months)
Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Children, ImPACT at a Dose of 1 Hour/Week: Children, ImPACT at 4 Hours/Week: Children are not included in the analysis as the measure's intent is to assess parent outcomes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) | Baseline | 35.5 total score on a scale | Standard Deviation 2.27 |
| Treatment as Usual | Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) | Follow-Up | 41.3 total score on a scale | Standard Deviation 2.24 |
| ImPACT at a Dose of 1 Hour/Week | Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) | Baseline | 40.2 total score on a scale | Standard Deviation 2.1 |
| ImPACT at a Dose of 1 Hour/Week | Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) | Follow-Up | 36.8 total score on a scale | Standard Deviation 3.18 |
| ImPACT at 4 Hours/Week | Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) | Baseline | 38.0 total score on a scale | Standard Deviation 2.67 |
| ImPACT at 4 Hours/Week | Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) | Follow-Up | 40.8 total score on a scale | Standard Deviation 2.57 |
Project ImPACT Coaching Fidelity Checklist
Clinician fidelity is measured using the Project ImPACT Coaching Fidelity Checklist. The checklist measures the providers' use of the core components to Project ImPACT. The form uses a 3-point score (scored from 0-2): 0, Not observed; 1, partially observed; and 2, observed. The final score is a summary percentage rating of overall fidelity with a range of 0-100%.
Time frame: 3 Month Follow-Up (3 month time frame)
Population: Treatment as Usual providers did not implement Project ImPACT and were not evaluated using this fidelity measure. Participants in the arms/groups Treatment as Usual: Families, ImPACT at a Dose of 1 Hour/Week: Families, ImPACT at 4 Hours/Week: Families are not included in the analysis as the measure's intent is to assess the provider's adherence to the intervention. Parent adherence to the intervention was assessed with a separate measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ImPACT at a Dose of 1 Hour/Week | Project ImPACT Coaching Fidelity Checklist | 55 percentage of fidelity | Standard Deviation 21 |
| ImPACT at 4 Hours/Week | Project ImPACT Coaching Fidelity Checklist | 59 percentage of fidelity | Standard Deviation 24 |
Project ImPACT Intervention Fidelity Checklist
Parent Treatment Adherence will be assessed through a videotaped parent-child interaction at home. Parent behavior will be scored for use of the intervention strategies using the Project ImPACT Intervention Fidelity Checklist. The scores range from 1 to 5, the higher the score representing the most adherence to the Project ImPACT intervention. The overall score is an average of scores from each item.
Time frame: 6 months
Population: Treatment as Usual Children/Caregivers didn't receive the Project ImPACT intervention and not evaluated for their adherence to it. Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists are not included in the analysis as the measure's intent is to assess caregiver adherence to the intervention. A separate measure was used to evaluate interventionist's adherence.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ImPACT at a Dose of 1 Hour/Week | Project ImPACT Intervention Fidelity Checklist | 2.8 score on a scale | Standard Deviation 0.6 |
| ImPACT at 4 Hours/Week | Project ImPACT Intervention Fidelity Checklist | 3.2 score on a scale | Standard Deviation 0.7 |
Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain
The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Communication domain is 20-140. Higher scores indicate better outcomes.
Time frame: Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.
Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Caregivers, ImPACT at a Dose of 1 Hour/Week: Caregivers, and ImPACT at 4 Hours/Week: Caregivers are not included in the analysis as the measure's intent is to assess child outcomes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain | Baseline | 69.4 units on a scale | Standard Deviation 15.2 |
| Treatment as Usual | Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain | Follow-Up | 69.4 units on a scale | Standard Deviation 15.7 |
| ImPACT at a Dose of 1 Hour/Week | Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain | Baseline | 65.2 units on a scale | Standard Deviation 14 |
| ImPACT at a Dose of 1 Hour/Week | Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain | Follow-Up | 61.4 units on a scale | Standard Deviation 21.6 |
| ImPACT at 4 Hours/Week | Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain | Baseline | 63.4 units on a scale | Standard Deviation 18 |
| ImPACT at 4 Hours/Week | Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain | Follow-Up | 54.9 units on a scale | Standard Deviation 18.4 |
Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain
The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Socialization domain is 20-140. Higher scores indicate better outcomes.
Time frame: 6 months
Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Caregivers, ImPACT at a Dose of 1 Hour/Week: Caregivers, and ImPACT at 4 Hours/Week: Caregivers are not included in the analysis as the measure's intent is to assess child outcomes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain | Baseline | 84.3 score on a scale | Standard Deviation 12.2 |
| Treatment as Usual | Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain | Follow-Up | 78.7 score on a scale | Standard Deviation 14.4 |
| ImPACT at a Dose of 1 Hour/Week | Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain | Baseline | 76.4 score on a scale | Standard Deviation 12.8 |
| ImPACT at a Dose of 1 Hour/Week | Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain | Follow-Up | 74.2 score on a scale | Standard Deviation 19 |
| ImPACT at 4 Hours/Week | Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain | Baseline | 75.6 score on a scale | Standard Deviation 15 |
| ImPACT at 4 Hours/Week | Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain | Follow-Up | 70.1 score on a scale | Standard Deviation 14.3 |
Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
The PEACE Fidelity Tool measures a provider's caregiver coaching quality by evaluating the quality and use of evidence based caregiver coaching strategies during recorded EI session across 5 domains (collaboration, daily routines, demonstration, practice and feedback, and reflection). The tool consists of 25 items scored on a 5 point scale from 1-5. Domains and total scores are calculated by averaging items. Scores can range from 1-5, with higher scores indicating better coaching competency and quality.
Time frame: 3 Month Follow Up (3 Months)
Population: Participants in the arms/groups Treatment as Usual: Families, ImPACT at a Dose of 1 Hour/Week: Families, ImPACT at 4 Hours/Week: Families are not included in the analysis as the measure's intent is to assess provider coaching fidelity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool | 2.8 units on a scale | Standard Deviation 0.6 |
| ImPACT at a Dose of 1 Hour/Week | Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool | 2.7 units on a scale | Standard Deviation 0.4 |
| ImPACT at 4 Hours/Week | Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool | 2.6 units on a scale | Standard Deviation 0.7 |