90 Participants NeededMy employer runs this trial

Telehealth Coaching for Autism Spectrum Disorder

JS
Overseen ByJessica Simacek, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth coaching program for parents of young children who may have autism spectrum disorder (ASD). The treatment uses a Naturalistic Developmental Behavioral Intervention (NDBI), which helps children learn skills in a natural setting and supports parents in using everyday routines for teaching. Families will either start the program immediately or wait 12 weeks before beginning. The trial suits families with children aged 1 to 5 who are awaiting an ASD diagnosis or intervention and can commit to three short sessions over 12 weeks. As an unphased study, this trial offers families the chance to explore innovative support strategies for their children.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on telehealth coaching for autism spectrum disorder, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that this telehealth coaching intervention is safe for children with autism spectrum disorder?

Research has shown that Naturalistic Developmental Behavioral Interventions (NDBIs) are generally safe and well-tolerated for children with autism. Over the past 20 years, studies have demonstrated that these interventions are effective and well-received by caregivers. They improve communication, language, and everyday skills in natural settings, making them easy for parents to use at home.

These interventions employ proven teaching methods that enhance motivation and learning, and they integrate seamlessly into daily activities. Given their long history of use, strong evidence supports their safety and effectiveness. While they may not address every aspect of autism, they have produced positive results in important developmental areas without significant negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Naturalistic Developmental Behavioral Intervention (NDBI) for Autism Spectrum Disorder because it integrates developmental principles into everyday activities, making it easier for parents to use at home. Unlike traditional therapies that might occur in clinical settings, NDBI focuses on naturalistic routines and family-centered interventions, which may enhance how children acquire and maintain new skills in their daily environments. This approach not only aligns with recommended early intervention practices but also has the potential to improve the generalization of skills, offering a more seamless integration into a child's life.

What evidence suggests that the NDBI telehealth coaching is effective for improving outcomes in children with Autism Spectrum Disorder?

Research shows that Naturalistic Developmental Behavioral Interventions (NDBIs), which participants in this trial may receive, help improve skills in children with autism. Studies have found that NDBIs enhance language, social communication, play skills, and thinking abilities. For example, a review of studies found that NDBIs significantly improve understanding and use of language. Caregivers notice better skill development in their children and find these methods easy to use. Evidence supports that NDBIs benefit both children and caregivers, leading to better outcomes.15678

Who Is on the Research Team?

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Jessica Simacek, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for children ages 1 to 5 who may have autism or are waiting for an autism diagnosis, and are not currently getting intensive behavioral therapy. At least one caregiver must be willing to participate. Children with very severe or dangerous behaviors may not be eligible.

Inclusion Criteria

Providers to participate who are in 'lead' or supervising roles (e.g., clinical supervisors, lead therapists, level II/level I EIDBI providers)
Ability to complete approximately three, 30 min sessions over 12 weeks and to complete pre and post study measures
My child is not currently getting 10+ hours a week of intensive behavioral therapy.
See 4 more

Exclusion Criteria

Children will be assessed through an eligibility screener to determine if they have challenging behavior that may be dangerous. Families will be assessed to determine eligibility through a screener, several of the questions will be aimed to identify challenging behavior severity, behaviors including topographies such as eye gouging and other forms of severe self-injury or aggression that cause significant or dangerous tissue damage (e.g., such as breaking the skin, drawing blood, open wounds that could be infected, or leaves a contusion, visits to an emergency room or hospitalization due to challenging behavior) to a child or others may be considered too severe to participate in the study.
Families will also be asked if a participating caregiver is pregnant, if they indicate yes, they will still be eligible to participate with their child, but certain activities may be skipped if the child engages in challenging behavior, such as aggressive behavior.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist

Families randomized to this condition have a 12-week waiting period before starting the NDBI intervention

12 weeks

Treatment

Participants receive the Naturalistic Developmental Behavioral Intervention (NDBI) via telehealth to improve child communication and behavioral outcomes

12 weeks

Follow-up

Participants are monitored for changes in autism impact, social communication, repetitive behaviors, family experience, and caregiver strategy implementation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NDBI

Trial Overview

The study tests a parent coaching program delivered by telehealth, where trained providers guide caregivers to help improve their child's communication and behavior. The goal is also to see if this approach works well for families in remote areas or military families.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Naturalistic Developmental Behavioral Intervention (NDBI)Experimental Treatment1 Intervention
Group II: WaitlistActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

A systematic review and network meta-analysis

The findings from our analysis suggest that ESDM may be considered as the most effective intervention for improving receptive language, expressive language and ...

Naturalistic Developmental Behavioral Interventions - PMC - NIH

The last 20 years of research have demonstrated both methods for identifying ASD in even younger children, and also methods for improving outcomes of those ...

Understanding the Effects of Naturalistic Developmental ...

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

Naturalistic Developmental Behavioral Interventions for ...

Effectiveness of individual versus group Early Start Denver Model interventions in children with autism spectrum disorder · Probability of Intervention Benefit ...

Examining variability in Naturalistic Developmental Behavioral ...

Results suggested that caregiver skills improve through participation in NDBIs and may directly contribute to their children's outcomes.

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.

Overview of Meta-Analyses on Naturalistic Developmental ...

We found positive effects of NDBIs on child's communication/language, cognition, and adaptive behavior. We found mixed effects for NDBIs on autism ...

Naturalistic Developmental Behavioral Intervention for 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 .