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Cognitive Behavioral Therapy

Executive Function Treatment for Autism Spectrum Disorder

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 will test a cognitive behavioral intervention, Unstuck and On Target High School (UOT:HS), for transition-age youth with autism spectrum disorder (ASD). The intervention will be delivered by school staff and focus on key functions needed for adult success. Behavioral and parent-report data will be collected prior to intervention, post-intervention, and at 6-month follow-up.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adaptive Behavior (at follow-up)
Classroom Behavior
Secondary outcome measures
Adaptive Behavior (end of intervention)
Other outcome measures
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.

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
214 Previous Clinical Trials
253,312 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
~18 spots leftby Oct 2024