RECRUITING

Implementation of Naturalistic Developmental Behavioral Intervention (NDBI) Through Coaching Caregivers of Young Autistic Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

NDBI Training and Coaching

Quick Facts

Study Start:2025-04-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06923553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 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.
  1. 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. 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. 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.

Contacts and Locations

Study Contact

James Lee, PhD, MPH, BCBA-D
CONTACT
(512) 471-3223
carelab@utexas.edu

Study Locations (Sites)

University of Texas Austin
Austin, Texas, 78712
United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Hybrid type 1
  • autism
  • NDBI
  • family coaching
  • underserved families

Additional Relevant MeSH Terms

  • Implementation Research