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

Not Applicable

• Conditions: Autism Spectrum Disorder; Executive Dysfunction; Adolescent Behavior

• Registration Number: NCT05017779
• Lead Sponsor: Children's National Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-24
• Study Start: 2021-09-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. full scale IQ > 80 on a standardized IQ test, either confirmed through educational testing within the last two years or confirmed by the WASI-2 administered by research personnel. Students with a verbal IQ above 75 will be considered for inclusion based on a discussion with teacher guided by probes related to pragmatic language that align with verbal demands of the curriculum.

2. Two of the following:

   • eligible and/or receiving school-based services or supports for autism
   • a prior clinical diagnosis of autism from a qualified health professional (as indicated by parent report)
   • a score of > 7 on the Social Communication Questionnaire via parent report and/or a score of > 11 via teacher report
   • a score of > 6 on the Autism Spectrum Quotient-10 via self-report

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Classroom Behavior	Baseline to End of Intervention (up to end of academic year, approx 9 months)	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.
Adaptive Behavior (at follow-up)	Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Adaptive Behavior (end of intervention)	Baseline, End of Intervention (up to end of academic year, approx 9 months)	Change in adaptive behavior will serve as the secondary outcome at the 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 (mean=100; SD=15), with higher scores indicating better adaptive skills.

Trial Locations

Locations (1)

Center for Autism Spectrum Disorders, Children's National Hospital; 🇺🇸 Rockville, Maryland, United States