Naturalistic Developmental Behavioral Intervention for Autism

Overseen By James Lee, PhD, MPH, BCBA-D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Non-Korean speakers, Children over 5, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help caregivers learn effective strategies to support young children with autism or similar developmental challenges. Video modules and weekly virtual coaching enable caregivers to practice and improve their skills in interacting with their children in natural settings. The focus is on enhancing the child's social and communication skills through everyday interactions. Caregivers of children aged 0-5, who are Korean speakers and have children diagnosed with autism, developmental delay, or disability, might be a good fit for this trial. This approach is known as Naturalistic Developmental Behavioral Interventions (NDBIs). As an unphased trial, this study offers caregivers a unique opportunity to enhance their skills and directly contribute to innovative autism support strategies.

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 prior data suggests that these NDBI strategies are safe for young autistic children?

Research has shown that Naturalistic Developmental Behavioral Interventions (NDBIs) effectively help children with autism. These interventions improve language and social skills. Importantly, NDBIs are safe and do not cause significant side effects.

These methods boost motivation and engagement, making them suitable for young children. They emphasize natural interactions between adults and children, creating a comfortable learning environment. Overall, studies confirm the safety of NDBIs, with no reports of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Naturalistic Developmental Behavioral Interventions (NDBIs) for autism because these treatments integrate the principles of behavioral therapy with developmental science. Unlike traditional options like Applied Behavior Analysis (ABA) that often rely on structured environments, NDBIs are more flexible and focus on natural settings, making them more adaptable to a child's everyday life. This approach not only aims to improve social communication skills but also fosters greater engagement by incorporating a child's interests, which could lead to more meaningful and lasting improvements.

What evidence suggests that NDBIs might be an effective treatment for autism?

Studies have shown that Naturalistic Developmental Behavioral Interventions (NDBIs), which participants in this trial will receive, can benefit young children with autism. Research suggests that NDBIs may improve language, social skills, play, and thinking abilities. A review of studies found that NDBIs enhance both understanding and speaking skills. Additionally, parents often use NDBIs effectively, making them more accessible and practical. Overall, NDBIs rank among the most effective and well-supported behavioral treatments for autism. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: NDBI group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward deeper understanding and wide-scale implementation of naturalistic developmental behavioral interventions. D'Agostino, SR., Dueñas, AD., Bravo, A., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naturalistic Developmental Behavioral Interventions: Empirically Validated Treatments for Autism Spectrum Disorder. Schreibman, L., Dawson, G., Stahmer, AC., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4513196/

Naturalistic Developmental Behavioral Interventions

While there is a substantial research base supporting the effectiveness of behavioral interventions across the lifespan of ASD, empirical data on the efficacy ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S3050656525001282

A systematic review and network meta-analysis

This study assessed the efficacy of interventions across five domains: receptive language skills, expressive language skills, cognitive development, reduction ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8862714/

Understanding NDBI Effects: Project AIM Meta-analysis

Naturalistic Developmental Behavioral Interventions may increase language, social communication, play skills, and cognition in young children with autism.

4.

link.springer.com

link.springer.com/article/10.1007/s10803-024-06382-7

A Systematic Review and Meta-analysis | Journal of Autism ...

Results suggest that combining AAC with NDBI procedures may lead to better language outcomes than NDBIs alone for children on the autism spectrum with minimal ...

5.

bmcpediatr.biomedcentral.com

bmcpediatr.biomedcentral.com/articles/10.1186/s12887-024-04752-9

Comparison of the efficacy of parent-mediated NDBIs on ...

Naturalistic Developmental Behavior Interventions (NDBIs) are among the most effective, evidence-based, and widely used behavior interventions ...

6.

bmj.com

bmj.com/content/383/bmj-2023-076733

Autism intervention meta-analysis of early childhood ...

Statistically significant effects were estimated for developmental interventions on social communication outcomes (g=0.31, 95% confidence ...

7.

seattlechildrens.org

seattlechildrens.org/clinics/autism-center/the-autism-blog/naturalistic-developmental-behavioral-interventions/

Naturalistic Developmental Behavioral Interventions

NDBI combine effective teaching methods based on the science of ABA with the developmental methods known to enhance motivation, engagement and learning.

8.

products.brookespublishing.com

products.brookespublishing.com/Naturalistic-Developmental-Behavioral-Interventions-for-Autism-Spectrum-Disorder-P1142.aspx

Naturalistic Developmental Behavioral Interventions for ...

Naturalistic Developmental Behavioral Interventions (NDBI) are some of today's most effective, evidence-based, and widely used interventions for autism ...

9.

pubs.asha.org

pubs.asha.org/doi/10.1044/2023_AJSLP-23-00116

Naturalistic Developmental Behavioral Interventions for ...

NDBIs are a widely accepted and validated approach for treating language-related symptoms in autism spectrum disorder, including deficits in vocabulary, social ...