Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:49 AM
Study NCT ID:
NCT07471594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention
Sponsor:
University of South Carolina
Organization:
Study Overview
Official Title:
Family-Centered Implementation of Parent Training for Emotion Regulation in Autistic Toddlers Within the Part C Early Intervention System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23MH137383-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |