An interventional study of Project ImPACT in Autism Spectrum Disorder, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged Up to 30 Months. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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?
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 79 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Exclusion Criteria:
The families keep receiving their treatment as usual
ImPACT at a dose of 1 hour/week over 6 months
Behavioral: Project ImPACT
ImPACT at 4 hours/week over 6 months.
Behavioral: 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).
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.
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)
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)
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)
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
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)
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
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)
| Milestone | Treatment as Usual: Children | Treatment as Usual: Early Interventionists | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Children | 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 | ImPACT at a Dose of 4 Hours/Week: Caregivers |
|---|---|---|---|---|---|---|---|---|---|
| Started | 18 | 6 | 18 | 23 | 6 | 23 | 20 | 6 | 20 |
| Completed | 12 | 6 | 12 | 16 | 6 | 16 | 17 | 6 | 17 |
| Not completed | 6 | 0 | 6 | 7 | 0 | 7 | 3 | 0 | 3 |
| Withdrew: Suspended/terminated ei services | 4 | 0 | 4 | 6 | 0 | 6 | 2 | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Switched agency/setting | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 |
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.
| units on a scale | Treatment as Usual | ImPACT at a Dose of 1 Hour/Week | ImPACT at 4 Hours/Week |
|---|---|---|---|
| Baseline | 69.4 ± 15.2 | 65.2 ± 14.0 | 63.4 ± 18.0 |
| Follow-Up | 69.4 ± 15.7 | 61.4 ± 21.6 | 54.9 ± 18.4 |
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.
| score on a scale | Treatment as Usual: Children | ImPACT at a Dose of 1 Hour/Week: Children | ImPACT at 4 Hours/Week: Children |
|---|---|---|---|
| Baseline | 35.6 ± 29.2 | 36.6 ± 8.5 | 37.0 ± 8.8 |
| Follow-Up | 29.2 ± 10.3 | 34.8 ± 10.3 | 36.2 ± 5.6 |
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.
| score on a scale | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Caregivers | ImPACT at 4 Hours/Week: Caregivers |
|---|---|---|---|
| Baseline | 87.3 ± 9.7 | 84.8 ± 9.4 | 87.74 ± 6.14 |
| Follow-Up | 87.5 ± 9.1 | 89.4 ± 12.2 | 89.95 ± 9.98 |
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.
| total score on a scale | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Caregivers | ImPACT at 4 Hours/Week: Caregivers |
|---|---|---|---|
| Baseline | 35.5 ± 2.27 | 40.2 ± 2.10 | 38.0 ± 2.67 |
| Follow-Up | 41.3 ± 2.24 | 36.8 ± 3.18 | 40.8 ± 2.57 |
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.
| score on a scale | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Caregivers | ImPACT at 4 Hours/Week: Caregivers |
|---|---|---|---|
| Project ImPACT Intervention Fidelity Checklist | — | 2.8 ± 0.6 | 3.2 ± 0.7 |
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%.
| percentage of fidelity | Treatment as Usual | ImPACT at a Dose of 1 Hour/Week | ImPACT at 4 Hours/Week |
|---|---|---|---|
| Project ImPACT Coaching Fidelity Checklist | — | 55 ± 21 | 59 ± 24 |
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.
| score on a scale | Treatment as Usual | ImPACT at a Dose of 1 Hour/Week | ImPACT at 4 Hours/Week |
|---|---|---|---|
| Baseline | 84.3 ± 12.2 | 76.4 ± 12.8 | 75.6 ± 15.0 |
| Follow-Up | 78.7 ± 14.4 | 74.2 ± 19.0 | 70.1 ± 14.3 |
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.
| units on a scale | Treatment as Usual: Early Interventionists | ImPACT at a Dose of 1 Hour/Week: Early Interventionists | ImPACT at 4 Hours/Week: Early Interventionists |
|---|---|---|---|
| Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool | 2.8 ± 0.6 | 2.7 ± 0.4 | 2.6 ± 0.7 |
Collected over Adverse event data was collected for the course of 2 years for the study. Each participant's adverse event data was assessed during their study duration. For child/parent dyads, this was starting at Baseline and ending once they completed the 6 Month Followup assessment (6-7 month time period). For early interventionists, the adverse event period was starting at enrollment until all their enrolled child/parent dyads were finished with study procedures and their enrollment was complete (2 years). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment as Usual: Children | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Treatment as Usual: Early Interventionists | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| ImPACT at a Dose of 1 Hour/Week: Children | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| ImPACT at a Dose of 1 Hour/Week: Early Interventionists | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| ImPACT at 4 Hours/Week: Children | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| ImPACT at 4 Hours/Week: Early Interventionists | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Treatment as Usual: Caregivers | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| ImPACT at a Dose of 1 Hour/Week: Caregivers | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| ImPACT at 4 Hours/Week: Caregivers | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
Sex/gender was not collected for caregiver participants in all treatment groups. The sociodemographic form did not contain questions about the sex/gender of caregiver participants, and their overall count for this section will be 0.
| Age, Categorical(Participants) | Treatment as Usual: Children | Treatment as Usual: Early Interventionists | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Children | 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 | ImPACT at 4 Hours/Week: Caregivers | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 18 | 0 | 0 | 23 | 0 | 0 | 20 | 0 | 0 | 61 |
| Between 18 and 65 years | 0 | 6 | 18 | 0 | 6 | 23 | 0 | 6 | 20 | 79 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Treatment as Usual: Children | Treatment as Usual: Early Interventionists | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Children | 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 | ImPACT at 4 Hours/Week: Caregivers | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 1.92 ± 0.42 | 42.4 ± 9.66 | 28.9 ± 5.9 | 1.86 ± 0.48 | 42.2 ± 9.24 | 32.0 ± 7.2 | 2.02 ± 0.26 | 39.5 ± 8.71 | 35.8 ± 9.6 | 10.74 ± 16.48 |
| Sex: Female, Male(Participants) | Treatment as Usual: Children | Treatment as Usual: Early Interventionists | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Children | 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 | ImPACT at 4 Hours/Week: Caregivers | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 8 | 4 | 0 | 6 | 6 | 0 | 8 | 6 | 0 | 38 |
| Male | 10 | 2 | 0 | 17 | 0 | 0 | 12 | 0 | 0 | 41 |
| Race (NIH/OMB)(Participants) | Treatment as Usual: Children | Treatment as Usual: Early Interventionists | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Children | 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 | ImPACT at 4 Hours/Week: Caregivers | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 4 |
| Asian | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 6 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Black or African American | 9 | 1 | 6 | 9 | 3 | 12 | 10 | 2 | 9 | 61 |
| White | 5 | 3 | 5 | 7 | 3 | 6 | 3 | 4 | 4 | 40 |
| More than one race | 0 | 0 | 3 | 2 | 0 | 4 | 1 | 0 | 1 | 11 |
| Unknown or Not Reported | 1 | 1 | 1 | 3 | 0 | 0 | 5 | 0 | 5 | 16 |
| Region of Enrollment(participants) | Treatment as Usual: Children | Treatment as Usual: Early Interventionists | Treatment as Usual: Caregivers | ImPACT at a Dose of 1 Hour/Week: Children | 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 | ImPACT at 4 Hours/Week: Caregivers | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| United States | 18 | 6 | 18 | 23 | 6 | 23 | 20 | 6 | 20 | 140 |
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University of Pennsylvania