Implementation ResearchNCT06923553
Implementation of Naturalistic Developmental Behavioral Intervention (NDBI) Through Coaching Caregivers of Young Autistic Children
A study testing NDBIs in people with Implementation Research, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implementation Research
- What is being tested?
- NDBIs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Austin
Austin, Texas, 78712
James Lee, (512) 471-3223, carelab@utexas.edu
About this study
Official title: NDBI Training and Coaching
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.
Read the detailed description
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.
- Recruitment and Consent Process Recruitment will take place across the United States and Korea, utilizing social media platforms (e.g., Facebook groups), community organizations, and professional networks. Flyers containing a QR code will direct potential participants to a Qualtrics page hosted by UT Austin, where they will receive detailed study information and complete an initial eligibility screening. 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.
- Intervention Procedures The intervention consists of 10 weekly sessions (30 minutes each) where trained Board Certified Behavior Analysts (BCBAs) will provide coaching to caregivers on how to implement NDBI strategies in daily interactions with their child. Each session will focus on practicing and refining specific behavioral techniques to promote communication and engagement. Coaching sessions will be conducted via video conferencing (e.g., Zoom) or in-person, depending on participant location. 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.
- Clinician Coaching and Supervision BCBAs conducting caregiver training will also receive coaching sessions to ensure fidelity in delivering the intervention. These sessions will focus on reviewing caregiver progress, discussing implementation challenges, and refining coaching techniques. 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.
- Data Collection and Outcome Measures 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:
- Vineland-3 Adaptive Behavior Scale: Assesses child adaptive behavior.
- WHOQOL (World Health Organization Quality of Life Questionnaire): Measures caregiver well-being.
- Autism-Specific Parenting Self-Efficacy Scale: Evaluates caregiver confidence in managing their child's behavior.
- Social Validity Measures (AIM, IAM, FIM): Evaluate caregiver satisfaction and acceptability of the intervention. All measures will be administered via Qualtrics to maximize accessibility for participants.
- Interviews and Focus Group Sessions After completing the intervention, caregivers will participate in structured interviews or focus group discussions to provide qualitative feedback on their experiences. These sessions will be conducted via Zoom or another secure video conferencing platform. 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.
- Data Security and Confidentiality All research activities will take place online to maximize participation and accessibility. Data will be securely stored on password-protected servers, and only authorized research personnel will have access. Video recordings and consent forms will be stored separately from research data, and all identifying information will be de-identified prior to analysis. Additionally, this is a collaborative study that involves UT Austin researchers working with external researchers who are responsible for data collection, analysis of de-identified data, and dissemination of research findings.
- Conditions
- Implementation Research
- Being tested
- NDBIs
- Keywords
- Hybrid type 1, autism, NDBI, family coaching, underserved families
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDBIsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| NDBI group | Experimental | Not described Receives: Behavioral: NDBIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to the end of treatment at 10 weeks
WHOQOL (World Health Organization Quality of Life Questionnaire)
Measures caregiver well-being
Measured: 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
Measured: 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.
Measured: From baseline to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implementation ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James D Lee, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923553
- Sponsor's protocol ID
- STUDY00007006
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NDBI Training and Coaching
- ClinicalTrials.gov ID
- NCT06923553
- Acronym / sponsor ID
- STUDY00007006
- Conditions
- Implementation Research
- Keywords
- Hybrid type 1, autism, NDBI, family coaching, underserved families
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Recruitment and Consent Process Recruitment will take place across the United States and Korea, utilizing social media platforms (e.g., Facebook groups), community organizations, and professional networks. Flyers containing a QR code will direct potential participants to a Qualtrics page hosted by UT Austin, where they will receive detailed study information and complete an initial eligibility screening. 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.
- Intervention Procedures The intervention consists of 10 weekly sessions (30 minutes each) where trained Board Certified Behavior Analysts (BCBAs) will provide coaching to caregivers on how to implement NDBI strategies in daily interactions with their child. Each session will focus on practicing and refining specific behavioral techniques to promote communication and engagement. Coaching sessions will be conducted via video conferencing (e.g., Zoom) or in-person, depending on participant location. 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.
- Clinician Coaching and Supervision BCBAs conducting caregiver training will also receive coaching sessions to ensure fidelity in delivering the intervention. These sessions will focus on reviewing caregiver progress, discussing implementation challenges, and refining coaching techniques. 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.
- Data Collection and Outcome Measures 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:
- Vineland-3 Adaptive Behavior Scale: Assesses child adaptive behavior.
- WHOQOL (World Health Organization Quality of Life Questionnaire): Measures caregiver well-being.
- Autism-Specific Parenting Self-Efficacy Scale: Evaluates caregiver confidence in managing their child's behavior.
- Social Validity Measures (AIM, IAM, FIM): Evaluate caregiver satisfaction and acceptability of the intervention. All measures will be administered via Qualtrics to maximize accessibility for participants.
- Interviews and Focus Group Sessions After completing the intervention, caregivers will participate in structured interviews or focus group discussions to provide qualitative feedback on their experiences. These sessions will be conducted via Zoom or another secure video conferencing platform. 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.
- Data Security and Confidentiality All research activities will take place online to maximize participation and accessibility. Data will be securely stored on password-protected servers, and only authorized research personnel will have access. Video recordings and consent forms will be stored separately from research data, and all identifying information will be de-identified prior to analysis. Additionally, this is a collaborative study that involves UT Austin researchers working with external researchers who are responsible for data collection, analysis of de-identified data, and dissemination of research findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NDBI group | Experimental | Behavioral: NDBIs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDBIsCaregivers 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. | Behavioural | NDBI group |
Primary outcome
Vineland-3 Adaptive Behavior Scale
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.
WHOQOL (World Health Organization Quality of Life Questionnaire)
Time frame: From baseline to the end of treatment at 10 weeks
Measures caregiver well-being
Autism-Specific Parenting Self-Efficacy Scale
Time frame: From baseline to the end of treatment at 10 weeks
Evaluates caregiver confidence in managing their child's behavior
Acceptability of Intervention Measure
Time frame: From baseline to the end of treatment at 10 weeks
4-item instrument measuring caregiver satisfaction and acceptability of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDBIs in people with Implementation Research, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Lee, PhD, MPH, BCBA-D ((512) 471-3223, carelab@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vineland-3 Adaptive Behavior Scale (time frame: From baseline to the end of treatment at 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.