A Trial of Project ImPACT in Early Intervention

Autism Spectrum Disorder Clinical Trial

Official title:

A Randomized Trial of Project ImPACT, an Evidence-based Intervention for Infants and Toddlers With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729127
• Other study ID #: 842506
• Status: Completed
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 31, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Months

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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).

Locations

Country	Name	City	State
United States	Center for Mental Health	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vineland Adaptive Behavior Scales 3rd Edition	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.	6 months
Primary	Brief Observation of Social Communication Change (BOSCC)	Measure of treatment-response for social-communication behaviors. The score range of the BOSCC is 0-5, with higher score being indicative of more atypical behavior.	6 months
Primary	Early Intervention Parenting Self-Efficacy Scale (EIPSES)	Measure of parent self-efficacy. 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.	6 months
Primary	Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)	Parent Responsiveness will be measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (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; = Behavior barely there, sometimes; = Behavior seen often; Assessors add scores for each item to calculate a domain score. No overall score is calculated. The authors provide a scoring grid that may be used to interpret domain scores by age. The grid summarizes scores indicative of high risk, moderate risk, and strenght (e.g. low/no risk) for each domain such that risk corresponds to suboptimal toddler development.	6 months
Primary	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.	6 months
Primary	Project ImPACT Coaching Fidelity Checklist	Clinician fidelity will be measured using the Project ImPACT Coaching Fidelity Checklist. The scores range from 0 to 5, the higher the score representing the most adherence to the Project ImPACT intervention.	6 months