Recruiting

Parent Training

Sponsor:

University of South Carolina

Code:

NCT07471594

Conditions

Autism

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

Interventions

Parent Training

Study Details

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

Study ID

NCT07471594

Start date

Mar 1, 2026

Status verified date

Jul, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

The following is a list of inclusion and exclusion criteria by participant group across all three research aims.

Inclusion Criteria for All Participants:

  • Able to provide written and informed consent;
  • Both sexes and all racial and ethnic origins;
  • English fluency (necessary for informed consent and measure completion)

Inclusion Criteria for Providers:

  • 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.

Exclusion Criteria for Providers:

  • 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)

Inclusion Criteria for Caregiver in Caregiver-Child Dyad:

  • 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

Exclusion Criteria for Caregiver in Caregiver-Child Dyad:

  • Not between 18 and 75 years of age
  • Not the legal guardian of the child
  • Not able to be present for BabyNet services

Inclusion Criteria for Children in Caregiver-Child Dyad:

  • 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.

Exclusion Criteria for Children in Caregiver-Child Dyad:

  • Is not between 12 and 36 months of age
  • Is not receiving services in BabyNet at least one half-hour per week
  • Is not 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
  • Does not have elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Parent Training

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

Primary outcome measure

  • Parent Training Treatment Acceptability [ Time Frame: 8 weeks after the start of intervention (1-3 weeks post intervention) ]

Central Contacts and Locations

Central contacts

Sarah R Edmunds, PhD

(803) 386-1150sredmunds@sc.edu

Locations

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29208

More Information

Sponsor

University of South Carolina

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • emotion regulation
  • early intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-07-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.