NCT07471594 · University of South Carolina
Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention
What this study is about
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).
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Parent Training Treatment Acceptability
Time frame: 8 weeks after the start of intervention (1-3 weeks post intervention)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Columbia, South Carolina
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations