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

Primary Purpose

Executive Dysfunction, Autism Spectrum Disorder, Adolescent Behavior

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unstuck & On Target: High School
Treatment as Usual
Sponsored by
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Executive Dysfunction focused on measuring Autism Spectrum Disorder, Executive Functioning, Intervention, High school

Eligibility Criteria

14 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Autism Spectrum Disorders, Children's National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention (Unstuck & On Target: High School)

Usual Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 27, 2021
Last Updated
October 13, 2023
Sponsor
Children's National Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05017779
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Executive Dysfunction, Autism Spectrum Disorder, Adolescent Behavior
Keywords
Autism Spectrum Disorder, Executive Functioning, Intervention, High school

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (Unstuck & On Target: High School)
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Unstuck & On Target: High School
Other Intervention Name(s)
Formerly Flexible Futures
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Classroom Behavior
Description
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.
Time Frame
Baseline to End of Intervention (up to end of academic year, approx 9 months)
Title
Adaptive Behavior (at follow-up)
Description
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.
Time Frame
Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)
Secondary Outcome Measure Information:
Title
Adaptive Behavior (end of intervention)
Description
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.
Time Frame
Baseline, End of Intervention (up to end of academic year, approx 9 months)
Other Pre-specified Outcome Measures:
Title
Executive Function Challenge Task (EFCT)
Description
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.
Time Frame
Baseline to End of Intervention (up to end of academic year, approx 9 months)
Title
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Description
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.
Time Frame
Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)
Title
Dimensional Change Card Sort - NIH Toolbox
Description
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.
Time Frame
Baseline to End of Intervention (up to end of academic year, approx 9 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 capacity to benefit and understand unstuck material as determined by teacher Exclusion Criteria: 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. Student is not able to participate in UOT:HS due to their schedule or ability to benefit from curriculum material as determined by teacher.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cara Pugliese, PhD
Organizational Affiliation
Children's Research Institute, Children's National Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Autism Spectrum Disorders, Children's National Hospital
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual data that supports the results will be shared via the National Institute of Mental Health's National Data Archive (NDA).
IPD Sharing Time Frame
Descriptive/raw de-identified data will be reported semi-annually through NDA.
IPD Sharing Access Criteria
Request login access to NDA data

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

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