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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parent Training Treatment Acceptability', 'timeFrame': '8 weeks after the start of intervention (1-3 weeks post intervention)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Parent Training Fidelity', 'timeFrame': 'Weekly up to 8 weeks', 'description': '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'}, {'measure': 'Parent Training Family Fit', 'timeFrame': '8 weeks after the start of intervention (1-3 weeks post intervention)', 'description': '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.'}, {'measure': 'Parent Training Readiness', 'timeFrame': 'Weekly up to 8 weeks', 'description': "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."}, {'measure': 'Child Emotion Regulation', 'timeFrame': '8 weeks after the start of intervention (1-3 weeks post intervention)', 'description': '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.'}, {'measure': 'Caregiver Stress', 'timeFrame': '8 weeks after the start of intervention (1-3 weeks post intervention)', 'description': "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."}, {'measure': 'Caregiver Self-Efficacy', 'timeFrame': '8 weeks after the start of intervention (1-3 weeks post intervention)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emotion regulation', 'early intervention'], 'conditions': ['Autism']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEmotion 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.\n\nParent 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).\n\nThe 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.\n\nThe 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:\n\nAim 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.\n\nA 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.\n\nAim 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).\n\nReceiving 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.\n\nAim 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.\n\nThe 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.\n\nIncreased 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'The following is a list of inclusion and exclusion criteria by participant group across all three research aims.\n\nInclusion Criteria for All Participants:\n\n* Able to provide written and informed consent;\n* Both sexes and all racial and ethnic origins;\n* English fluency (necessary for informed consent and measure completion)\n\nInclusion Criteria for Providers:\n\n* Is between 18 and 75 years of age\n* Holds a contract with or formally employed by BabyNet\n* Provides services within BabyNet at least one half-hour per week\n* 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.\n\nExclusion Criteria for Providers:\n\n* Not contracted or employed by BabyNet\n* Provides services less than one half-hour per week\n* 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)\n\nInclusion Criteria for Caregiver in Caregiver-Child Dyad:\n\n* Is between 18 and 75 years of age\n* Is the legal guardian of the participating child\n* Child is receiving services within BabyNet at least one half-hour per week - Caregiver participates or is present for BabyNet services\n\nExclusion Criteria for Caregiver in Caregiver-Child Dyad:\n\n* Not between 18 and 75 years of age\n* Not the legal guardian of the child\n* Not able to be present for BabyNet services\n\nInclusion Criteria for Children in Caregiver-Child Dyad:\n\n* Is between 12 and 36 months of age\n* Is enrolled in BabyNet services at least one half-hour per week\n* 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\n* Has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.\n\nExclusion Criteria for Children in Caregiver-Child Dyad:\n\n* Is not between 12 and 36 months of age\n* Is not receiving services in BabyNet at least one half-hour per week\n* 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\n* Does not have elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.'}, 'identificationModule': {'nctId': 'NCT07471594', 'briefTitle': 'Family-Centered Implementation of Parent Training for Autistic Toddlers in Early Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Family-Centered Implementation of Parent Training for Emotion Regulation in Autistic Toddlers Within the Part C Early Intervention System', 'orgStudyIdInfo': {'id': 'Pro00142099'}, 'secondaryIdInfos': [{'id': '1K23MH137383-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23MH137383-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parent Training', 'description': '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.', 'interventionNames': ['Behavioral: Parent Training']}, {'type': 'NO_INTERVENTION', 'label': 'EI Practice-As-Usual (PAU)', 'description': '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': [{'name': 'Parent Training', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a form of behavioral parent training as described in the "Manage Your Child\'s Challenging Behavior" module of Project ImPACT.', 'armGroupLabels': ['Parent Training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah R Edmunds, PhD', 'role': 'CONTACT', 'email': 'sredmunds@sc.edu', 'phone': '(803) 386-1150'}], 'overallOfficials': [{'name': 'Sarah R Edmunds, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Required to submit data to NIMH NDA as described in our Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychology', 'investigatorFullName': 'Sarah Rose Edmunds', 'investigatorAffiliation': 'University of South Carolina'}}}}