N/A
N=140
A Trial of Project ImPACT in Early Intervention
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04729127 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain — 69.4; 65.2; 63.4; 69.4 units on a scale — p=.79
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Project ImPACT (Behavioral)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain |
69.4; 65.2; 63.4; 69.4; 61.4; 54.9 | .79 |
| PRIMARY Brief Observation of Social Communication Change (BOSCC) |
35.6; 36.6; 37.0; 29.2; 34.8; 36.2 | .04 sig |
| PRIMARY Early Intervention Parenting Self-Efficacy Scale (EIPSES) |
87.3; 84.8; 87.74; 87.5; 89.4; 89.95 | .78 |
| PRIMARY Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO) |
35.5; 40.2; 38.0; 41.3; 36.8; 40.8 | .07 |
| PRIMARY Project ImPACT Intervention Fidelity Checklist |
2.8; 3.2 | — |
| PRIMARY Project ImPACT Coaching Fidelity Checklist |
55; 59 | — |
| PRIMARY Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain |
84.3; 76.4; 75.6; 78.7; 74.2; 70.1 | .26 |
| SECONDARY Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool |
2.8; 2.7; 2.6 | — |
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?
Eligibility Criteria
Inclusion Criteria
- child is <30 months of age (to receive 6 months of intervention)
- a classification of autism or high autism risk as determined by the EI system;
- receive early intervention services through the infant and toddler program; and
- parent is willing to complete the parent measures that are part of this study.
Exclusion Criteria
- be over 30 months of age
Data sourced from ClinicalTrials.gov (NCT04729127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.