50 Participants Needed

Naturalistic Developmental Behavioral Intervention for Autism

JL
Overseen ByJames Lee, PhD, MPH, BCBA-D
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas at Austin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment NDBIs for autism?

Research shows that Naturalistic Developmental Behavioral Interventions (NDBIs) are effective for young children with autism. These interventions use strategies from both behavioral and developmental sciences and have been shown to help teach important skills in natural settings.12345

Is Naturalistic Developmental Behavioral Intervention (NDBI) safe for humans?

The research articles reviewed do not specifically address the safety of Naturalistic Developmental Behavioral Interventions (NDBIs) in humans, focusing instead on their effectiveness and implementation challenges.12367

How does the treatment Naturalistic Developmental Behavioral Intervention (NDBI) for autism differ from other treatments?

Naturalistic Developmental Behavioral Interventions (NDBIs) are unique because they are implemented in natural settings and involve shared control between the child and therapist, using natural consequences to teach skills. This approach combines strategies from both behavioral and developmental sciences, making it distinct from other autism treatments that may not integrate these elements or focus on naturalistic settings.12346

Eligibility Criteria

This trial is for primary caregivers of young children aged 0-5 who are diagnosed with autism, developmental delay, or disability. Caregivers must be at least 18 years old and of Korean descent. Clinicians in the trial need BCBA certification and experience with behavioral intervention for this age group.

Inclusion Criteria

My child, aged 0-5, has been diagnosed with ASD or developmental issues.
I am a caregiver of a young child with autism or developmental issues and am of Korean descent.
I am a certified BCBA with experience in child behavioral intervention.

Exclusion Criteria

Clinicians without a valid Board Certified Behavior Analyst (BCBA) certification, lacking experience in providing intervention for children aged 0-5, or only working with children over the age of 6.
I am over 5 years old and do not have a diagnosis of autism, developmental delay, or disability.
I am a caregiver for children over 6, don't speak Korean, or can't fully participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (virtual)

Intervention

Caregivers receive training and coaching on NDBI strategies through weekly sessions

10 weeks
10 visits (virtual or in-person)

Data Collection and Outcome Measures

Assessments conducted to measure caregiver skill acquisition, child developmental progress, and intervention effectiveness

1 week
1 visit (virtual)

Follow-up

Participants are monitored for feedback and qualitative data collection through interviews or focus groups

2 weeks
1-2 visits (virtual)

Treatment Details

Interventions

  • NDBIs
Trial Overview The study tests a training program using video modules to teach caregivers NDBI strategies for autistic children's development. It involves weekly virtual sessions with clinicians over 10 weeks, including watching videos, planning homework, practicing strategies, and receiving feedback.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: NDBI groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

Findings from Research

Naturalistic Developmental Behavioral Interventions (NDBI) combine applied behavioral and developmental sciences to support early autism diagnosis and intervention, emphasizing the importance of teaching skills in natural settings.
NDBIs involve shared control between the child and therapist and utilize natural consequences to promote developmentally appropriate skills, highlighting the need for further research to clarify and improve these interventions for families and service providers.
Naturalistic Developmental Behavioral Interventions: Empirically Validated Treatments for Autism Spectrum Disorder.Schreibman, L., Dawson, G., Stahmer, AC., et al.[2022]
Naturalistic Developmental Behavioral Interventions (NDBIs) are effective early interventions for children on the autism spectrum, but they are not widely used in practice due to various barriers.
The paper outlines common features of NDBIs, addresses misconceptions, and emphasizes the need for better training and support for practitioners to promote their broader implementation.
Toward deeper understanding and wide-scale implementation of naturalistic developmental behavioral interventions.D'Agostino, SR., Dueรฑas, AD., Bravo, A., et al.[2023]

References

Naturalistic Developmental Behavioral Interventions: Empirically Validated Treatments for Autism Spectrum Disorder. [2022]
Balancing Fidelity and Flexibility: Usual Care for Young Children With an Increased Likelihood of Having Autism Spectrum Disorder Within an Early Intervention System. [2023]
Toward deeper understanding and wide-scale implementation of naturalistic developmental behavioral interventions. [2023]
Identifying and measuring the common elements of naturalistic developmental behavioral interventions for autism spectrum disorder: Development of the NDBI-Fi. [2023]
Early Intervention Provider-Reported NDBI Use and Relationships with Provider- to System-Level Implementation Determinants. [2023]
The Role of Naturalistic Developmental Behavioral Interventions in Early Intervention for Autistic Toddlers: An Observational Study. [2023]
Understanding the Effects of Naturalistic Developmental Behavioral Interventions: A Project AIM Meta-analysis. [2022]
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