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

NCT06923553 | Recruiting

• 1 other identifier: STUDY00007006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Implementation Research

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Vineland-3 Adaptive Behavior Scale

  The Vineland-3 Adaptive Behavior Composite (ABC) standard score, which summarizes adaptive behavior across domains, has a minimum score of 20 and a maximum score of 160. The higher scores indicate a better outcome.

  From baseline to the end of treatment at 10 weeks

• WHOQOL (World Health Organization Quality of Life Questionnaire)

  Measures caregiver well-being

  From baseline to the end of treatment at 10 weeks

• Autism-Specific Parenting Self-Efficacy Scale

  Evaluates caregiver confidence in managing their child's behavior

  From baseline to the end of treatment at 10 weeks

• Acceptability of Intervention Measure

  4-item instrument measuring caregiver satisfaction and acceptability of the intervention.

  From baseline to the end of treatment at 10 weeks

Study Arms (1)

NDBI group

EXPERIMENTAL

Behavioral: NDBIs

Interventions

NDBIs BEHAVIORAL

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.

NDBI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

James Lee, PhD, MPH, BCBA-D

CONTACT

(512) 471-3223; carelab@utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 11, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)