University of Texas Austin
Austin, Texas, 78712, United States
Location status: Recruiting
NCT Number: NCT06923553
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Austin, Texas, 78712, United States
Location status: Recruiting
This study aims to evaluate the effectiveness of a caregiver-mediated intervention incorporating newly developed Naturalistic Developmental Behavioral Intervention (NDBI) modules and clinician coaching. The study consists of: (1) participant recruitment, (2) caregiver training, (3) clinician coaching, (4) data collection, and (5) participant feedback. Below is a detailed description of each phase of the study procedures.
Interested participants will review an embedded informed consent form, which includes a description of study procedures, potential risks, and confidentiality measures. Participants will have the opportunity to ask questions before providing consent. Once consent is obtained, they will complete baseline assessments to collect demographic information and initial measures related to intervention outcomes.
Caregivers will receive access to pre-recorded intervention videos demonstrating NDBI techniques, which they are expected to watch before each session. Each video is about 2-3 minutes long and available upon request. The modules are ready for caregivers' viewing online, and it includes topics such as following the child's lead, prompting, prompt fading, natural reinforcement, reciprocal interactions, turn taking, etc.
To evaluate caregiver strategy implementation, parents will record interactions with their child using a smartphone, tablet, or computer. These interactions will be pre-planned during their weekly session with the clinician who will help plan the specific context, routines, and activities in which the caregivers will practice implementing the strategies that they learned about. Then, caregivers will receive feedback in the next session based on the recordings. These recordings will not exceed 5 minutes in length. The participants will be instructed to only include consented parent and child to ensure privacy of surrounding individuals, if any. These recordings will be uploaded to a secure research platform (e.g., encrypted cloud storage or Qualtrics) for analysis. Videos will be reviewed by research team members to assess strategy fidelity and caregiver engagement.
All clinician coaching sessions will be recorded using Zoom (or another HIPAA-compliant video conferencing platform) and stored on encrypted servers for analysis. These recordings will be used to assess clinician fidelity using a validated fidelity checklist.
Participants will complete assessments at baseline (pre-intervention) and post-intervention to measure caregiver skill acquisition, child developmental progress, and intervention effectiveness. The following research measures will be used:
All measures will be administered via Qualtrics to maximize accessibility for participants.
Participants will have the option to turn off their cameras during discussions to maintain privacy. Interviews and focus groups will be recorded and stored on encrypted servers, with transcripts de-identified before analysis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From baseline to the end of treatment at 10 weeks
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.
Time frame: From baseline to the end of treatment at 10 weeks
Measures caregiver well-being
Time frame: From baseline to the end of treatment at 10 weeks
Evaluates caregiver confidence in managing their child's behavior
Time frame: From baseline to the end of treatment at 10 weeks
4-item instrument measuring caregiver satisfaction and acceptability of the intervention.
Contact information is provided by the study sponsor or research team.
University of Texas at Austin
Other
NDBI Training and Coaching
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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