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

Children's National

Status: Invitation-only

Conditions: Autism Spectrum Disorder; Adolescent Behavior; Executive Dysfunction

Treatments: Behavioral: Unstuck & On Target: High School; Other: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05017779

R01MH124772

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 14 to 22 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

Intervention (Unstuck & On Target: High School)

Experimental group

Description:

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.

Treatment:

Behavioral: Unstuck & On Target: High School

Usual Care

Other group

Description:

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.

Treatment:

Other: Treatment as Usual