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

NCT ID: NCT05017779

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention (Unstuck & On Target: High School)

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.

Group Type: EXPERIMENTAL

Unstuck & On Target: High School

Intervention Type: 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.

Usual Care

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 Type: OTHER

Treatment as Usual

Intervention Type: 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.

Interventions

Unstuck & On Target: High School

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

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.

Intervention Type: OTHER

Other Intervention Names

Formerly Flexible Futures

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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,)

3. Capacity to benefit and understand unstuck material as determined by teacher

Exclusion Criteria

1. 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.

2. Student is not able to participate in UOT:HS due to their schedule or ability to benefit from curriculum material as determined by teacher.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Lauren Kenworthy

Chief of Neuropsychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren Kenworthy, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Research Institute, Children's National Hospital

Locations

Center for Autism Spectrum Disorders, Children's National Hospital

Rockville, Maryland, United States

Countries

United States

Other Identifiers

R01MH124772

Identifier Type: NIH

Identifier Source: org_study_id

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