A Trial of Project ImPACT in Early Intervention

University of Pennsylvania

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Project ImPACT

Study type: Interventional

Funder types: Other

Identifiers

NCT04729127

842506

Details and patient eligibility

About

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?

Full 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.

Enrollment: 79 patients

Sex: All

Ages: Under 30 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 3 patient groups

Treatment as usual

No Intervention group

Description:

The families keep receiving their treatment as usual

ImPACT at a dose of 1 hour/week

Active Comparator group

Description:

ImPACT at a dose of 1 hour/week over 6 months

Treatment:

Behavioral: Project ImPACT

ImPACT at 4 hours/week

Active Comparator group

Description:

ImPACT at 4 hours/week over 6 months.

Treatment:

Behavioral: Project ImPACT