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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
Study 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 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)
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.
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Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
210 Previous Clinical Trials
207,533 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- The student spends at least 20% of their time in mainstream educational services, as identified in their IEP or through teacher report.Your parents or teachers have reported that you have difficulty with social communication, scoring 11 or higher on a questionnaire.You have been diagnosed with autism by a healthcare professional or have an educational classification for autism.Someone who is considered to have a full scale IQ of 80 or higher is considered to have an above-average intelligence
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Intervention (Unstuck & On Target: High School)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this clinical trial ongoing at the present moment?
"Confirming data from clinicaltrials.gov, this medical trial is not currently accepting participants. It was first posted on the 7th of September 2021 and last modified on November 2nd 2021. However, there are 343 other trials that have active recruitment going at present."
Answered by AI
Does this research trial allow for applicants under the age of 65?
"This clinical research mandates that candidates must be aged between 14 and 22. In the same vein, trials for individuals under 18 years old are plentiful (288) while those above 65 have fewer options (59)."
Answered by AI
Does my profile meet the requirements to join this experiment?
"The trial is currently recruiting up to 224 individuals that have autism spectrum disorder and are aged 14-22."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Ohio
How old are they?
< 18
18 - 65
What site did they apply to?
Center for Autism Spectrum Disorders, Children's National Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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