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A Trial of Project ImPACT in Early Intervention

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ClinicalTrials.gov Identifier: NCT04729127
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Michigan State University
Information provided by (Responsible Party):
Melanie Pellecchia, PhD, University of Pennsylvania

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?

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Project ImPACT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Project ImPACT, an Evidence-based Intervention for Infants and Toddlers With Autism Spectrum Disorder
Actual Study Start Date : June 11, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


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

Active Comparator: ImPACT at 4 hours/week
ImPACT at 4 hours/week over 6 months.
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).




Primary Outcome Measures :
  1. Vineland Adaptive Behavior Scales 3rd Edition [ Time Frame: 6 months ]
    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.

  2. Brief Observation of Social Communication Change (BOSCC) [ Time Frame: 6 months ]
    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.

  3. Early Intervention Parenting Self-Efficacy Scale (EIPSES) [ Time Frame: 6 months ]
    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.

  4. Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) [ Time Frame: 6 months ]

    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

    1. = Behavior barely there, sometimes
    2. = 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.


  5. Project ImPACT Intervention Fidelity Checklist [ Time Frame: 6 months ]
    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. Project ImPACT Coaching Fidelity Checklist [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729127


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

Locations
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United States, Pennsylvania
Center for Mental Health Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elena Carranco Chavez, BS    267-574-0231    Elena.Carranco@pennmedicine.upenn.edu   
Contact: Samantha Crabbe, MSEd    (215) 573-8025    Samantha.Crabbe@pennmedicine.upenn.edu   
Principal Investigator: Melanie Pellecchia, PhD         
Sponsors and Collaborators
University of Pennsylvania
Michigan State University
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Responsible Party: Melanie Pellecchia, PhD, Principal investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04729127    
Other Study ID Numbers: 842506
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders