A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth

NCT05017779 | Completed DMC

• 1 other identifier: R01MH124772
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effectiveness of a school-based cognitive behavioral executive function (EF) intervention, Unstuck \& On Target High School (UOT:HS), for transition-age youth with autism spectrum disorder (ASD). UOT:HS was designed to be embedded in high schools and delivered by school staff to improve generalization of skills, increase access to mental health care, and fill a gap in evidence-based approaches to support postsecondary transition. UOT:HS targets flexibility and planning skills and focuses on key functions needed for adult success across 25, 1-hour lessons. School staff will be trained to deliver UOT:HS, study staff will provide ongoing check-ins, and parents will be offered home extensions for each lesson and two trainings to generalize skills to the home environment. Behavioral and parent-report data will be collected prior to intervention, post-intervention, and at 4-to-6-month follow-up.

Conditions

Executive Dysfunction; Autism Spectrum Disorder; Adolescent Behavior

Keywords

Autism Spectrum Disorder; Executive Functioning; Intervention; High school

Outcome Measures

Primary Outcomes (2)

• Classroom Behavior

  Change in Classroom Behavior will serve as the primary outcome at end of intervention. Classroom behavior will be assessed through 15-minute classroom observations conducted by a trained research staff member masked to treatment condition. Observations will occur during the school day in an academic (non-intervention) class. Raters use a standardized form to detect the presence or absence of seven observable behaviors: social appropriateness, on task behavior, initiation, transitions, organization, getting stuck/preservation, expression of overwhelm/negativity.

  Baseline to End of Intervention (up to end of academic year, approx 9 months)

• Adaptive Behavior (at follow-up)

  Change in adaptive behavior will serve as the primary outcome at follow-up (e.g., approximately six month after end of intervention). Adaptive behavior will be measured via parent-report on the Adaptive Behavior Assessment System, Third Edition (ABAS-3). The ABAS-3 is a well-validated parent report measure that assesses practical, everyday skills needed to effectively and independently take care of oneself and interact with others across the lifespan. Performance is represented as standard scores, with higher scores indicating better adaptive skills.

  Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)

Secondary Outcomes (1)

• Adaptive Behavior (end of intervention)

  Baseline, End of Intervention (up to end of academic year, approx 9 months)

Other Outcomes (3)

• Executive Function Challenge Task (EFCT)

  Baseline to End of Intervention (up to end of academic year, approx 9 months)

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

  Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)

• Dimensional Change Card Sort - NIH Toolbox

  Baseline to End of Intervention (up to end of academic year, approx 9 months)

Study Arms (2)

Intervention (Unstuck & On Target: High School)

EXPERIMENTAL

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.

Behavioral: Unstuck & On Target: High School

Usual Care

OTHER

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.

Other: Treatment as Usual

Interventions

Unstuck & On Target: High School BEHAVIORAL

Unstuck \& On Target: High School (UOT:HS) is a group-based curriculum for high school students that targets executive function skills using Cognitive Behavior Therapy (CBT) techniques. UOT:HS focuses on key functions needed for adult success, such as: self-advocacy, flexibility, time management, motivation, goal setting, developing plans, monitoring progress. Guided practice begins with concrete interventionist support and moves to interventionist cueing, self-cueing, and finally automatic use of the skills without support. Lessons are delivered by school personnel within the school setting. Home extension activities are provided to parents.

Also known as: Formerly Flexible Futures

Intervention (Unstuck & On Target: High School)

Treatment as Usual OTHER

Participants in schools assigned to the Treatment as Usual (TAU) condition will continue to receive the standard school-based IEP accommodations and school supports that would typically be provided. Data will be collected on the types of supports TAU schools offer, and what supports TAU students receive.

Usual Care

Eligibility Criteria

• Age: 14 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cognitive/Behavioral capacity to benefit and understand Unstuck material as determined by teacher guided by probes related to pragmatic language that align with verbal demands of the curriculum.
• Evidence of autism supported by at least one of the following:
• Eligible and/or receiving school-based services or supports for autism
• Prior clinical diagnosis of autism from a qualified health professional (as indicated by parent report)
• Demonstrates characteristics of autism consistent with DSM-5, as judged by a clinical autism expert, based on all available information gathered through the screening, consenting, and testing process (including information gathered through the Social Communication Questionnaire via parent/teacher report, and SRS-2,)
• Capacity to benefit and understand unstuck material as determined by teacher

You may not qualify if:

• Students must have a level of proficiency in English to complete questionnaires and study procedures in English. Parents must have a level of proficiency in English or Spanish to complete questionnaires and study procedures in English or Spanish.
• Student is not able to participate in UOT:HS due to their schedule or ability to benefit from curriculum material as determined by teacher.

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Center for Autism Spectrum Disorders, Children's National Hospital

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Adolescent Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Lauren Kenworthy, PhD

  Children's Research Institute, Children's National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Neuropsychology

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 24, 2021
• Study Start: September 7, 2021
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Descriptive/raw de-identified data will be reported semi-annually through NDA.
• Access Criteria: Request login access to NDA data

Locations

US (1)