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NCT06923553 · ClinicalTrials.gov registry record · NA

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

A NA study of Implementation Research, sponsored by University of Texas at Austin.

Recruiting
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT06923553: Recruiting NA study of Implementation Research, sponsored by University of Texas at Austin.

NCT06923553 is a NA study of Implementation Research that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 50 participants, below the 9,229-participant average among 4 other Implementation Research trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06923553, a NA study of Implementation Research, is actively recruiting participants, sponsored by University of Texas at Austin.

RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • BEHAVIORAL NDBIs

Study Locations (1)

Texas

  • University of Texas Austin - Austin

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2025-04-01
Est. Completion 2026-12-31
Phase NA
University of Texas at Austin

257 total trials

What NCT06923553 shows while recruiting

NCT06923553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 9,229-participant average among 4 other Implementation Research trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Implementation Research appearing as the primary indexed condition, and to 1 intervention - of which NDBIs is the first listed.

NCT06923553 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06923553 about?

NCT06923553 is a clinical study titled "Implementation of Naturalistic Developmental Behavioral Intervention (NDBI) Through Coaching Caregivers of Young Autistic Children". 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 n...

What is the current status of trial NCT06923553?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-04-01. Estimated completion is 2026-12-31.

What conditions does trial NCT06923553 study?

This clinical trial studies the following conditions: Implementation Research.

What interventions are being tested in trial NCT06923553?

The interventions under investigation include: NDBIs (BEHAVIORAL).

Who is sponsoring clinical trial NCT06923553?

This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06923553 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06923553, the US trial registry maintained by the National Library of Medicine. NCT06923553 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.