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

Autism Spectrum Disorder Clinical Trial

Official title:

A Hybrid Effectiveness-implementation Trial of a School Based Executive Function Treatment for Transition Age Autistic Youth

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05017779
• Other study ID #: R01MH124772
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2023
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 224
• Est. completion date: November 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Autism Spectrum Disorder
• Executive Dysfunction

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Center for Autism Spectrum Disorders, Children's National Hospital	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Executive Function Challenge Task (EFCT)	The "Executive Function Challenge Task" (EFCT) is an objective and ecologically valid task developed by our research team to assess flexibility and planning skills in a social context conducted by a trained research staff member masked to treatment condition. The EFCT uses a standardized, semi-structured protocol which does not provide explicit rules for completing the tasks to mimic the implicit, unspoken, unstructured expectations in everyday life. The EFCT consists of challenges across several activities and responses are scored on a 3-point scale for each task. The scale (0-good, 1-intermediate, 2-poor performance) has task-specific behavioral markers to guide scoring.	Baseline to End of Intervention (up to end of academic year, approx 9 months)
Other	Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)	The "Behavior Rating Inventory of Executive Function, Second Edition" (BRIEF-2) is a well-established parent-report measure of real-world EF skills, with the Shift subscale measuring cognitive flexibility.	Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)
Other	Dimensional Change Card Sort - NIH Toolbox	The Dimensional Change Card Sort (DCCS) (NIH Toolbox) is a 4-minute, standard lab-based task for assessing cognitive flexibility in terms of set-shifting. Participants are required to sort a series of bivalent cards first according to one dimension (e.g., color) and then according to another (e.g., shape). It is normed from ages 4-85.	Baseline to End of Intervention (up to end of academic year, approx 9 months)
Primary	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)
Primary	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	Adaptive Behavior (end of intervention)	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.	Baseline, End of Intervention (up to end of academic year, approx 9 months)