Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention

NCT07471594 | Not Yet Recruiting

• 2 other identifiers: Pro001420991K23MH137383-01A1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autism

Keywords

emotion regulation; early intervention

Outcome Measures

Primary Outcomes (1)

• Parent Training Treatment Acceptability

  Participants receiving Parent Training will complete an 18-item measure of treatment acceptability adapted from the Scale of Treatment Perceptions (STP; Berger et al., 2016). Treatment acceptability comprises how effective a participant views an intervention to be, as well as how feasible, acceptable, and appropriate it is. A composite average score will be calculated, and additional availability domains include "effectiveness", "family fit," and "negative aspects" of the intervention. Participants will rate each item on a Likert scale (1 = Strongly Disagree; 7 = Strongly Agree). A higher score (maximum = 7; minimum = 1) indicates greater treatment acceptability.

  8 weeks after the start of intervention (1-3 weeks post intervention)

Secondary Outcomes (6)

• Parent Training Fidelity

  Weekly up to 8 weeks

• Parent Training Family Fit

  8 weeks after the start of intervention (1-3 weeks post intervention)

• Parent Training Readiness

  Weekly up to 8 weeks

• Child Emotion Regulation

  8 weeks after the start of intervention (1-3 weeks post intervention)

• Caregiver Stress

  8 weeks after the start of intervention (1-3 weeks post intervention)

Study Arms (2)

Parent Training

EXPERIMENTAL

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.

Behavioral: Parent Training

EI Practice-As-Usual (PAU)

NO INTERVENTION

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.

Interventions

Parent Training BEHAVIORAL

Participants will receive a form of behavioral parent training as described in the "Manage Your Child's Challenging Behavior" module of Project ImPACT.

Parent Training

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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.
• Not contracted or employed by BabyNet
• Provides services less than one half-hour per week
• Does not provide services to a child 12-36 months of age at high-likelihood for ASD and with elevated emotion dysregulation (based on the POSI and the EDI-YC)
• 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
• Not between 18 and 75 years of age
• Not the legal guardian of the child

Sponsors & Collaborators

• University of South Carolina: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Autistic Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Sarah R Edmunds, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah R Edmunds, PhD

CONTACT

(803) 386-1150; sredmunds@sc.edu

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: Assistant Professor of Psychology

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share