What side effects are associated with this type of intervention?

Cognitive-behavioral interventions for Autism Spectrum Disorder, such as the Unstuck & On Target High School program, are generally well-tolerated. Potential side effects can include increased anxiety or emotional distress as individuals confront challenging thoughts and behaviors, as well as frustration or resistance to the structured nature of the therapy. Monitoring and adjusting the intervention can help manage these reactions.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for treating the core symptoms of Autism Spectrum Disorder (ASD). However, certain medications are approved to manage related symptoms such as irritability, aggression, and hyperactivity. For instance, Risperidone and Aripiprazole are FDA-approved for treating irritability associated with ASD in children and adolescents. Cognitive behavioral interventions like the Unstuck & On Target High School (UOT:HS) program focus on improving executive function skills such as flexibility and planning, which are crucial for adult success. These types of behavioral therapies are not typically subject to FDA approval but are widely recognized and utilized in clinical practice.

What other types of research exist?

<ol> <li>Mixed Martial Arts (MMA) Training: This intervention has shown effectiveness in improving executive functions in school-aged children with ASD through a structured 26-class program over 13 weeks.</li> <li></li> </ol> BOOST-A™: An online interactive program designed to empower adolescents on the autism spectrum to plan their transition from school to further study, training, or employment. 3. STEPS Program: The Stepped Transition in Education Program for Students with ASD supports high school and postsecondary students with ASD, focusing on transition support. 4. Video Modeling: This technique has been effective in teaching various skills, including task completion and abduction-prevention, to children with ASD, demonstrating skill maintenance and generalization over time.

← Back to Search

Cognitive Behavioral Therapy

Executive Function Treatment for Autism Spectrum Disorder

Q: What is the mechanism of action of this treatment?

Cognitive-behavioral interventions like the Unstuck &#x26; On Target High School (UOT:HS) program focus on enhancing executive function skills, including flexibility and planning, by teaching strategies to manage and adapt to changing situations. These skills are essential for daily functioning and successful transitions into adulthood for individuals with ASD. Other common treatments include behavioral-based interventions, which use reinforcement techniques to improve specific behaviors, and developmental models that focus on social communication and emotional regulation. These treatments are important as they address core deficits in ASD, helping individuals improve their social interactions, communication, and adaptive behaviors, ultimately leading to better long-term outcomes.

N/A

Waitlist Available

Led By Cara Pugliese, PhD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, end of intervention (up to end of academic year, approx 9 months)

Awards & highlights

Summary

This trial tests a school-based program called UOT:HS for high school students with autism. The program aims to improve planning and flexibility skills through lessons and parental involvement to help students succeed after high school.

Who is the study for?

This trial is for high school students with autism spectrum disorder who have an IQ of 80 or higher and are in mainstream classes at least 20% of the time. They must also show signs of social communication challenges. Students and caregivers must be proficient in English to participate.

What is being tested?

The study tests 'Unstuck & On Target: High School' (UOT:HS), a program designed to improve flexibility and planning skills among autistic youth. It involves school staff delivering lessons, check-ins by study staff, and parent trainings to extend learning at home.

What are the potential side effects?

As UOT:HS is a behavioral intervention focusing on executive function skills rather than medication, it does not have typical medical side effects. However, participants may experience stress or frustration as they learn new strategies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, end of intervention (up to end of academic year, approx 9 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, end of intervention (up to end of academic year, approx 9 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of intervention (up to end of academic year, approx 9 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adaptive Behavior (at follow-up)

Classroom Behavior

Secondary study objectives

Adaptive Behavior (end of intervention)

Other study objectives

Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

Dimensional Change Card Sort - NIH Toolbox

Executive Function Challenge Task (EFCT)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment1 Intervention

Participants in schools assigned to the TAU condition will continue to receive the standard school-based Individualized Education Plan (IEP) accommodations and school supports that would typically be provided.

Group II: Intervention (Unstuck & On Target: High School)Experimental Treatment1 Intervention

School staff will receive training on the Unstuck and On Target: High School (UOT:HS) curriculum, and deliver lessons to students during the school day. Interventionists will have the option to participate in ongoing check-ins with study staff. Parents are provided home extensions for each lesson and have the option to participate in trainings delivered by study staff to support generalization of skills to the home environment.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive-behavioral interventions like the Unstuck & On Target High School (UOT:HS) program focus on enhancing executive function skills, including flexibility and planning, by teaching strategies to manage and adapt to changing situations. These skills are essential for daily functioning and successful transitions into adulthood for individuals with ASD. Other common treatments include behavioral-based interventions, which use reinforcement techniques to improve specific behaviors, and developmental models that focus on social communication and emotional regulation. These treatments are important as they address core deficits in ASD, helping individuals improve their social interactions, communication, and adaptive behaviors, ultimately leading to better long-term outcomes.

[Fragile X syndrome: new therapeutic strategies].Neurologic treatment strategies in autism: an overview of medical intervention strategies.[Good practice guidelines for the treatment of autistic spectrum disorders].

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

218 Previous Clinical Trials

257,686 Total Patients Enrolled

2 Trials studying Autism Spectrum Disorder

132 Patients Enrolled for Autism Spectrum Disorder

Cara Pugliese, PhDPrincipal InvestigatorChildren's Research Institute, Children's National Hospital

Media Library

Unstuck & On Target: High School (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05017779 — N/A

Autism Spectrum Disorder Research Study Groups: Usual Care, Intervention (Unstuck & On Target: High School)

Autism Spectrum Disorder Clinical Trial 2023: Unstuck & On Target: High School Highlights & Side Effects. Trial Name: NCT05017779 — N/A

Unstuck & On Target: High School (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05017779 — N/A

~6 spots leftby Oct 2024

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.