An interventional study of Parent Training in Autism, sponsored by University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 12 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by University of South Carolina · Not applicable, Interventional, and Treatment
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.
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.
Emotion dysregulation, as indexed by frequent or unpredictable challenging behavior such as meltdowns and aggression, is a common family concern and a prominent aspect of ASD in toddlerhood. At least 50% of children with ASD exhibit challenging behavior, double the rate than in typically developing children. Challenging behavior can limit children's social and daily inclusion, predict later mental health challenges, and may weaken the efficacy of evidence-based early intervention. Challenging behavior is often misdiagnosed and over-pathologized in some children, who may therefore not be able to access evidence-based practices (EBPs) and services for autism and emotion dysregulation.
Parent Training is a collection of behavioral strategies (e.g., identifying antecedents, differential reinforcement, and teaching a replacement skill1) to help families reduce challenging behavior and improve emotion regulation in autism. Parent Training programs have demonstrated efficacy for autistic children across decades of research. However, Parent Training has not been implemented in Part C with toddlers with autism with the goal of fitting with families' values and Part C system constraints (Aim 1).
The successful implementation of Parent Training, like any evidence-based practice, relies not only on high family and provider acceptability, but also good fit with system and organizational characteristics. This study leverages new causal theory to mechanistically understand whether family and provider readiness (Aim 2), and system level characteristics (Aim 3) may enhance high quality Parent Training within Part C.
The objective of this K23 career development grant is to become an independent implementation scientist focused on autism services. Building on my training as a clinical scientist, I will learn to: use implementation methods that foster healthcare access; adapt interventions; explore mechanisms of both effectiveness and implementation; and evaluate system-level aspects of sustainable implementation. To enhance these goals, I propose a study that introduces Parent Training for emotion regulation in autism into the Part C EI system and determines its feasibility in this setting. The specific aims of this study are:
Aim 1. Assess the feasibility, acceptability, and preliminary effectiveness of Parent Training versus EI practice as usual (PAU) on caregivers' parenting stress and children's emotion dysregulation.
A preliminary effectiveness randomized controlled trial (RCT) will enroll a racially representative sample of n = 40 provider-caregiver dyads (i.e., \<53% white). A mixed-methods approach will be used to assess pre- and post- feasibility, acceptability, family fit, and preliminary effectiveness of each condition. Trial feasibility will be assessed using provider/caregiver enrollment, attendance, fidelity, and attrition.
Aim 2. Examine whether EIs' and caregivers' readiness to implement Parent Training strategies predicts their fidelity to and intent to use Parent Training. (within Aim 1 RCT).
Receiving Parent Training will foster greater weekly increases in self-reported readiness (attitudes, norms, self-efficacy, and knowledge) for each PT skill (vs. PAU), and will predict PT fidelity and intent to use.
Aim 3. Prepare for implementation at scale by identifying sources of practice variation and future implementation supports needed for Parent Training within the Part C context.
The cost effectiveness of PT within Part C will be assessed. Implementation determinants from the outer context (e.g., national Part C), inner context (e.g., agency, family), and intervention (e.g., modifications) domains will be assessed within the EPIS framework to inform implementation supports.
Increased accessibility of evidence-based intervention for emotion regulation in autistic toddlers may improve early autism service quality of for all children and result in better family-centered care. This proposal will provide preliminary data for an R01 application that will use a hybrid effectiveness-implementation RCT31 to implement Parent Training in Part C while addressing barriers to sustainability. This proposal aligns with Strategy 4.2.B of Goal 4 of the NIMH strategic plan, "Advancing Mental Health Services to Strengthen Public Health," by assessing the feasibility of implementing an EBP in a free-to-families public healthcare system. Through preparing to assess the effectiveness of Parent Training in Part C, while collecting information on adaptations and implementation factors to increase system fit, this application will accelerate implementation of EBPs while maintaining optimal child mental health outcomes.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 40 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.
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The following is a list of inclusion and exclusion criteria by participant group across all three research aims.
Inclusion Criteria for All Participants:
Inclusion Criteria for Providers:
Exclusion Criteria for Providers:
Inclusion Criteria for Caregiver in Caregiver-Child Dyad:
Exclusion Criteria for Caregiver in Caregiver-Child Dyad:
Inclusion Criteria for Children in Caregiver-Child Dyad:
Exclusion Criteria for Children in Caregiver-Child Dyad:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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 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.
Time frame: 8 weeks after the start of intervention (1-3 weeks post intervention)
Parent Training Fidelity
Providers and caregivers will complete a Knowledge Quiz after each PT session, which will be videotaped and coded for fidelity. Dr. Ingersoll will mentor Dr. Edmunds to create a fidelity assessment for Parent Training using the CORE Fidelity Method. The RISE Modification \& Adaptation survey, based on FRAME will be used to code incidental modifications
Time frame: Weekly up to 8 weeks
Parent Training Family Fit
Caregivers in the PT group will complete the FVAI, an interview about their family values and daily activities, and how PT fits or could fit within these.
Time frame: 8 weeks after the start of intervention (1-3 weeks post intervention)
Parent Training Readiness
Readiness to implement an EBP is multidimensional and is conceptualized to consist of all of the internal preconditions to EBP use in the Theory of Planned Behavior: EBP 1) attitudes; 2) norms; and 3) self-efficacy. We will use a customized version of the EBP Attitudes Scale, a 15-item scale with the best psychometrics compared to similar measures. We will assess providers' and caregivers' readiness to try using each PT strategy separately.
Time frame: Weekly up to 8 weeks
Child Emotion Regulation
The preliminary effectiveness of Parent Training vs. PAU on child emotion regulation will be assessed using a composite of the MAP-DB Temper Loss scale, the EDI-YC Reactivity Index, the HSQ-ASD, and the DB-DOS. The first 3 are Likert scale parent-report questionnaires (22 items, 15 items, and 16 items, respectively) with good psychometric properties. The MAP-DB measures the intensity, frequency, and context of irritable behavior and is valid in autism. The EDI-YC is a well validated measure of emotion dysregulation in autism. The HSQ-ASD is a behaviorally specific questionnaire that is sensitive to change and will be used to track interim weekly progress. The DB-DOS8 is a standardized, clinician-administered observational measure of irritability with prior use in autism.
Time frame: 8 weeks after the start of intervention (1-3 weeks post intervention)
Caregiver Stress
Caregiver stress will be assessed with the Parenting Stress Index (PSI)-Short Form. The PSI is a 36-item survey assessing caregivers' self-reported functioning in 3 domains: parental distress, parent-child functioning, and child behavior. Caregivers rate each item on a scale of (1 = Strongly Agree; 5 = Strongly Disagree). Higher scores on the PSI indicate greater distress.
Time frame: 8 weeks after the start of intervention (1-3 weeks post intervention)
Caregiver Self-Efficacy
Caregiver self-efficacy will be rated using the EI Parenting Self-Efficacy Scale (EIPSES). The EIPSES is a 16-item Likert scale designed to measure parenting efficacy in the context of early intervention. Participants rate each item on a 7-point Likert scale (1 = Strongly Disagree, 7 = Strongly Agree), with higher scores indicating greater self-efficacy.
Time frame: 8 weeks after the start of intervention (1-3 weeks post intervention)
Plan to share: Yes — Required to submit data to NIMH NDA as described in our Data Sharing Agreement.
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