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

Sponsor
Children's National Research Institute (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05017779
Collaborator
(none)
224
1
2
38.8
5.8

Study Details

Study Description

Brief Summary

This study will test the effectiveness of a school-based cognitive behavioral executive function (EF) intervention, Unstuck and 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 26, 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 6-month follow-up.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Unstuck & On Target: High School
  • Other: Treatment as Usual
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Hybrid Effectiveness-implementation Trial of a School Based Executive Function Treatment for Transition Age Youth With Autism
Actual Study Start Date :
Sep 7, 2021
Anticipated Primary Completion Date :
Oct 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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 Names:
  • Formerly Flexible Futures
  • Other: 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.

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Classroom Behavior [Baseline to End of Intervention (up to end of academic year)]

      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.

    2. 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

    1. Adaptive Behavior (end of intervention) [Baseline, 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.

    Other Outcome Measures

    1. Executive Function Challenge Task (EFCT) [Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)]

      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.

    2. Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) [Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)]

      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.

    3. Dimensional Change Card Sort - NIH Toolbox [Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • full scale IQ ≥ 80 on a standardized Intelligence Quotient (IQ) test, either confirmed through educational testing within the last two years or confirmed by the Wechsler Abbreviated Scale of Intelligence (WASI-2) administered by research personnel

    • educational classification of autism or a prior clinical diagnosis of autism from a qualified health professional

    • enrollment in mainstream educational services at least 20% of the time, as identified in their IEP or through teacher report

    • a score of ≥ 11 on the Social Communication Questionnaire via parent and/or teacher report

    Exclusion Criteria:
    • Students and caregivers without a level of proficiency in English to complete questionnaires and study procedures in English.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Autism Spectrum Disorders, Children's National Hospital Rockville Maryland United States 20850

    Sponsors and Collaborators

    • Children's National Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cara Pugliese, Clinical Psychologist, Children's National Research Institute
    ClinicalTrials.gov Identifier:
    NCT05017779
    Other Study ID Numbers:
    • R01MH124772
    First Posted:
    Aug 24, 2021
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cara Pugliese, Clinical Psychologist, Children's National Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2021