Clinical trial NCT04729127: A Trial of Project ImPACT in Early Intervention
Official title: A Randomized Trial of Project ImPACT, an Evidence-based Intervention for Infants and Toddlers With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Michigan State University
First posted: 2021-01-28
Enrollment: 79
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain
timeFrame: Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.
measure: Brief Observation of Social Communication Change (BOSCC)
timeFrame: Baseline and 6 Month Follow Up (Exit) (6 months)
measure: Early Intervention Parenting Self-Efficacy Scale (EIPSES)
timeFrame: Baseline and 6 Month Follow Up (6 months)
measure: Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)
timeFrame: Collected at Baseline and 6 Month Follow Up (time frame: 6 months)
measure: Project ImPACT Intervention Fidelity Checklist
timeFrame: 6 months
measure: Project ImPACT Coaching Fidelity Checklist
timeFrame: 3 Month Follow-Up (3 month time frame)
measure: Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain
timeFrame: 6 months
Secondary outcomes:
measure: Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
timeFrame: 3 Month Follow Up (3 Months)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Mental Health
state: Pennsylvania
Study officials:
References: