Clinical trial NCT05017779: A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
Official title: A Hybrid Effectiveness-implementation Trial of a School Based Executive Function Treatment for Transition Age Autistic Youth
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Executive Dysfunction
Autism Spectrum Disorder
Adolescent Behavior
Keywords: Autism Spectrum Disorder
Executive Functioning
Intervention
High school
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 224
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Classroom Behavior
timeFrame: Baseline to End of Intervention (up to end of academic year, approx 9 months)
measure: Adaptive Behavior (at follow-up)
timeFrame: Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)
Secondary outcomes:
measure: Adaptive Behavior (end of intervention)
timeFrame: Baseline, End of Intervention (up to end of academic year, approx 9 months)
Other outcomes:
measure: Executive Function Challenge Task (EFCT)
timeFrame: Baseline to End of Intervention (up to end of academic year, approx 9 months)
measure: Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
timeFrame: Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)
measure: Dimensional Change Card Sort - NIH Toolbox
timeFrame: Baseline to End of Intervention (up to end of academic year, approx 9 months)
Locations:
city: Rockville
country: United States
facility: Center for Autism Spectrum Disorders, Children's National Hospital
state: Maryland
Study officials:
affiliation: Children's Research Institute, Children's National Hospital
name: Lauren Kenworthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: