Philadelphia, Pennsylvania 19104

  • Autism Spectrum Disorder

Purpose:

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?


Study summary:

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.


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


Study is Available At:


Original ID:

842506


NCT ID:

NCT04729127


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

30 Months


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pennsylvania


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

126


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Elena Carranco Chavez, BS
(267) 574-0231
elena.carranco@pennmedicine.upenn.edu
Backup Contact:Samantha Crabbe, MSEd
(215) 573-8025
Samantha.Crabbe@pennmedicine.upenn.edu

Study Dates

Start Date:June 11, 2020
Completion Date:August 2022
Completion Type:Anticipated
Primary Completion Date:December 2021
Primary Completion Type:Anticipated
Verification Date:January 2021
Last Changed Date:January 27, 2021
First Received Date:January 22, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Vineland Adaptive Behavior Scales 3rd Edition
Time Frame:6 months
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Brief Observation of Social Communication Change (BOSCC)
Time Frame:6 months
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Early Intervention Parenting Self-Efficacy Scale (EIPSES)
Time Frame:6 months
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)
Time Frame:6 months
Safety Issues:False
Description: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,
Outcome Type:Primary Outcome
Measure:Project ImPACT Intervention Fidelity Checklist
Time Frame:6 months
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Project ImPACT Coaching Fidelity Checklist
Time Frame:6 months
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Behavioral
Name:Project ImPACT
Description: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).
Arm Name:ImPACT at 4 hours/week

Study Arms

Study Arm Type:No Intervention
Arm Name:Treatment as usual
Description:The families keep receiving their treatment as usual
Study Arm Type:Active Comparator
Arm Name:ImPACT at a dose of 1 hour/week
Description:ImPACT at a dose of 1 hour/week over 6 months
Study Arm Type:Active Comparator
Arm Name:ImPACT at 4 hours/week
Description:ImPACT at 4 hours/week over 6 months.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Pennsylvania
Agency Class:Other
Agency Type:Collaborator
Agency Name:Michigan State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 28, 2021

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