A Trial of Project ImPACT in Early Intervention

NCT04729127 | Completed Results

• 1 other identifier: 842506
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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?

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (7)

• Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain

  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. The standard score range for the Communication domain is 20-140. Higher scores indicate better outcomes.

  Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.

• Brief Observation of Social Communication Change (BOSCC)

  The BOSCC is a measure of treatment-response for social-communication behaviors. The BOSCC contains 12 items in total. The score range of individual items is 0-5. Items are then summed to a total score. The range for a total score is 0-60. Higher scores are an indication of more symptom severity.

  Baseline and 6 Month Follow Up (Exit) (6 months)

• Early Intervention Parenting Self-Efficacy Scale (EIPSES)

  The EIPSES is a measure of parent self-efficacy. It is a 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. Once items are summed, the total score ranges from 16-112, with higher scores indicating better self-efficacy and empowerment.

  Baseline and 6 Month Follow Up (6 months)

• Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)

  Parent Responsiveness is measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™). 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 1. = Behavior barely there, sometimes 2. = Behavior seen often Assessors add scores for each item to calculate a domain score and an overall domain score. Total scores can range from 0-58, with higher scores indicating more parent responsiveness to child behavior and actions.

  Collected at Baseline and 6 Month Follow Up (time frame: 6 months)

• 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. The overall score is an average of scores from each item.

  6 months

• Project ImPACT Coaching Fidelity Checklist

  Clinician fidelity is measured using the Project ImPACT Coaching Fidelity Checklist. The checklist measures the providers' use of the core components to Project ImPACT. The form uses a 3-point score (scored from 0-2): 0, Not observed; 1, partially observed; and 2, observed. The final score is a summary percentage rating of overall fidelity with a range of 0-100%.

  3 Month Follow-Up (3 month time frame)

• Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain

  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. The standard score range for the Socialization domain is 20-140. Higher scores indicate better outcomes.

  6 months

Secondary Outcomes (1)

• Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool

  3 Month Follow Up (3 Months)

Study Arms (3)

Treatment as usual

NO INTERVENTION

The families keep receiving their treatment as usual

ImPACT at a dose of 1 hour/week

ACTIVE COMPARATOR

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

Behavioral: Project ImPACT

ImPACT at 4 hours/week

ACTIVE COMPARATOR

ImPACT at 4 hours/week over 6 months.

Behavioral: Project ImPACT

Interventions

Project ImPACT BEHAVIORAL

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).

ImPACT at 4 hours/week; ImPACT at a dose of 1 hour/week

Eligibility Criteria

• Age: Up to 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \) be over 30 months of age

Sponsors & Collaborators

• University of Pennsylvania: lead
• Michigan State University: collaborator

Study Sites (1)

Center for Mental Health

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

The study occurred during the height of the COVID-19 pandemic leading to additional stressors and burdens for participating providers and families. High attrition in family participants occurred largely due to families dropping their services with their provider. BOSCC video recordings were recorded in families' homes over Zoom, which introduced a high variability in quality.

Results Point of Contact

• Title: Melanie Pellecchia
• Organization: University of Pennsylvania

melanie.pellecchia@pennmedicine.upenn.edu

215-746-1950

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 28, 2021
• Study Start: June 11, 2020
• Primary Completion: August 15, 2022
• Study Completion: August 31, 2022
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)