NCT06923553 Implementation of Naturalistic Developmental Behavioral Intervention (NDBI) Through Coaching Caregivers of Young Autistic Children
| NCT ID | NCT06923553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Implementation Research |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Naturalistic developmental behavioral interventions (NDBIs) are a newer class of evidence-based interventions for young autistic children to promote their positive developmental or behavioral outcomes. These are often delivered by family members or other natural change agents given the emphasis on naturalistic transactions between an adult and a child. Despite the emerging evidence, there are practical difficulties that hinder wider dissemination and implementation of NDBIs, including low level of access to some of these branded, packaged NDBIs. To mitigate these difficulties related to access, we have created a series of video modules that demonstrate nine commonly used core components in NDBI strategies. In this study, caregivers will receive training and coaching using these modules and both synchronous and asynchronous coaching from a clinician. In this type 1 hybrid implementation trial, there are two groups of participants: (1) caregivers of young autistic children or children with other developmental disabilities/delays, (2) children, and (3) clinicians. Caregivers will meet with clinicians virtually weekly to (a) watch the newly developed NDBI videos that demonstrate the strategy use, (b) discuss how this might be applied to their own child, (c) receive individualized homework planning, (d) record and upload videos of their practice of strategy use with their own child, and (e) review the videos with clinicians to receive individualized feedback on their strategy use. This will occur for 10 weeks. Each session will be video recorded to assess the clinicians' intervention fidelity. After 10 weeks, pre-post tests will be conducted to assess parents' confidence on implementing these strategies, their child's social communication, and satisfaction of providers and caregivers. Qualitative data will also be collected via interviews with some selected participants to gain a deeper understanding of their perceptions.
Eligibility Criteria
Inclusion Criteria: 1. Caregivers: Primary caregivers of young children aged 0-5 who meet one of the following conditions: (1) diagnosed with autism spectrum disorder, (2) diagnosed with developmental delay, and (3) diagnosed with a developmental disability. Eligible caregivers include: (1) parents, (2) grandparents, (3) legal guardians. All caregivers must be at least 18 years old and must be of Korean descent. 2. Clinicians: The clinicians must hold a current Board Certified Behavior Analyst (BCBA) certification and must have experience delivering behavioral intervention and caregiver training for children aged 0-5. 3. Children: Children in this study must be between 0-5 years old and must have a formal medical diagnosis confirming one of the following conditions: (1) autism spectrum disorder (ASD), (2) developmental delay, or (3) developmental disability. Exclusion Criteria: 1. Caregivers: Caregivers will be excluded if they (1) primarily care for children over the age of 6, (2) are not Korean speakers, or (3) are unable to fully participate in study activities, such as watching training videos, recording parent-child interactions, or completing required questionnaires. 2. Clinicians: Clinicians will be excluded if they (1) do not hold a valid Board Certified Behavior Analyst (BCBA) certification, (2) lack experience in providing behavioral intervention and caregiver training for children aged 0-5, or (3) only work with children over the age of 6. 3. Children: Children will be excluded if they (1) are older than 5 years, (2) do not have a formal medical diagnosis confirming autism spectrum disorder, developmental delay, or developmental disability.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06923553 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Implementation Research. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06923553 currently recruiting?
Yes, NCT06923553 is actively recruiting participants. Contact the research team at carelab@utexas.edu for enrollment information.
Where is the NCT06923553 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT06923553 clinical trial?
NCT06923553 is sponsored by University of Texas at Austin. The trial plans to enroll 50 participants.