Recruiting

NDBI Training

Sponsor:

University of Texas at Austin

Code:

NCT06923553

Conditions

Implementation Research

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NDBIs

Study Details

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

Study ID

NCT06923553

Start date

Apr 1, 2025

Status verified date

Apr, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NDBI group

Interventions

NDBIs

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.

Primary outcome measure

  • Vineland-3 Adaptive Behavior Scale [ Time Frame: From baseline to the end of treatment at 10 weeks ]
  • WHOQOL (World Health Organization Quality of Life Questionnaire) [ Time Frame: From baseline to the end of treatment at 10 weeks ]
  • Autism-Specific Parenting Self-Efficacy Scale [ Time Frame: From baseline to the end of treatment at 10 weeks ]
  • Acceptability of Intervention Measure [ Time Frame: From baseline to the end of treatment at 10 weeks ]

Central Contacts and Locations

Central contacts

James Lee, PhD, MPH, BCBA-D

(512) 471-3223carelab@utexas.edu

Locations

University of Texas Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

More Information

Sponsor

University of Texas at Austin

Last update posted

Apr 11, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2025-04-11.