Autism Spectrum Disorder Clinical Trials

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Family-Centered Implementation of Parent Training for Emotion Regulation in Autistic Toddlers Within the Part C Early Intervention System

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 3
Healthy Volunteers: t
View:

• Able to provide written and informed consent;

• Both sexes and all racial and ethnic origins;

• English fluency (necessary for informed consent and measure completion)

• Is between 18 and 75 years of age

• Holds a contract with or formally employed by BabyNet

• Provides services within BabyNet at least one half-hour per week

• Provides therapeutic services within BabyNet to at least one child 12-36 months who is 1) at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI, and 2) has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.

• Is between 18 and 75 years of age

• Is the legal guardian of the participating child

• Child is receiving services within BabyNet at least one half-hour per week - Caregiver participates or is present for BabyNet services

• Is between 12 and 36 months of age

• Is enrolled in BabyNet services at least one half-hour per week

• Is considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI

• Has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.

Locations
United States
South Carolina
University of South Carolina
RECRUITING
Columbia
Contact Information
Primary
Sarah R Edmunds, PhD
sredmunds@sc.edu
(803) 386-1150
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 40
Treatments
Experimental: Parent Training
Participants in the Parent Training group will receive a form of behavioral parent training as described in the Manage Your Child's Challenging Behavior module of Project ImPACT.
No_intervention: EI Practice-As-Usual (PAU)
The EI practice-as-usual group will receive their typical services listed on their Individualized Family Service Plan (IFSP) within their IDEA Part-C funded early intervention sessions.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: University of South Carolina

This content was sourced from clinicaltrials.gov