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Behavioral Intervention

PEACE Toolkit for Autism

N/A
Waitlist Available
Led By Melanie Pellecchia, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Participants will be excluded if they do not speak English or Spanish, as the published intervention materials are currently available in English and Spanish and the research team is able to communicate with participants in English or Spanish only.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months (week 24)

Summary

"This trial will test a toolkit called PEACE to see how it helps early intervention providers work with families of young children with autism. They will enroll 200 providers and 400 parent-child pairs to see

Who is the study for?
This trial is for early intervention providers and families with young children diagnosed with Autism Spectrum Disorder. It aims to enroll 200 providers and 400 parent-child pairs, focusing on those who are currently receiving or can benefit from early intervention services.
What is being tested?
The study tests the PEACE implementation toolkit which includes weekly individual facilitation, online resources, and group sessions. The goal is to see if this support improves how caregivers coach families of autistic children in early interventions.
What are the potential side effects?
Since this trial involves educational and supportive interventions rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience emotional or psychological responses to the program.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I speak either English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months (week 24)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (week 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
Secondary study objectives
Acceptability, Appropriateness, and Adoption measure
Autism Impact Measure (AIM)
Confusion, Hubbub, and Order Scale (CHAOS)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Non Adherent: Individual FacilitationExperimental Treatment1 Intervention
After 16 weeks, providers may be randomized to receive individual facilitation with an expert coach if they continue to be non adherent to the use of parent coaching strategies.
Group II: Non Adherent: Group FacilitationExperimental Treatment1 Intervention
After 8 and 16 weeks, providers with low coaching adherence could be randomized to receive weekly group facilitation.
Group III: Adherent: Continue Online ResourcesActive Control1 Intervention
Providers who are adherent to parent coaching strategies during the 8 and 16 week timepoints will not be randomized and continue to use the PEACE Online Resources. They will not receive further implementation supports.
Group IV: Non Adherent: Continue Online ResourcesPlacebo Group1 Intervention
After 8 and 16 weeks, providers with low coaching adherence could be randomized to continue using the PEACE online resources with no further implementation supports.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,643 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
3,967 Patients Enrolled for Autism Spectrum Disorder
Michigan State UniversityOTHER
198 Previous Clinical Trials
685,155 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
1,269 Patients Enrolled for Autism Spectrum Disorder
Institute of Education SciencesFED
8 Previous Clinical Trials
2,612 Total Patients Enrolled
Melanie Pellecchia, PhDPrincipal InvestigatorUniversity of Pennsylvania
~400 spots leftby Nov 2027