## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** R01MH124772
**Link:** https://reporter.nih.gov/quickSearch/R01MH124772
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Children's National Research Institute
### Status Module
#### Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-17

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-13

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-10-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09-07

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2021-08-24
**Type:** ACTUAL
**Study First Submit Date:** 2021-07-27
**Study First Submit QC Date:** 2021-08-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's National Research Institute

#### Responsible Party

**Investigator Affiliation:** Children's National Research Institute

**Investigator Full Name:** Cara Pugliese

**Investigator Title:** Clinical Psychologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Executive Dysfunction

- Autism Spectrum Disorder

- Adolescent Behavior

**Keywords:**

- Autism Spectrum Disorder

- Executive Functioning

- Intervention

- High school

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 224

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: Unstuck & On Target: High School

**Label:** Intervention (Unstuck & On Target: High School)

**Type:** EXPERIMENTAL

#### Arm Group 2

**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 Names:**

- Other: Treatment as Usual

**Label:** Usual Care

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention (Unstuck & On Target: High School)

**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.

**Name:** Unstuck & On Target: High School

**Other Names:**

- Formerly Flexible Futures

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Usual Care

**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.

**Name:** Treatment as Usual

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**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.

**Measure:** Executive Function Challenge Task (EFCT)

**Time Frame:** Baseline to End of Intervention (up to end of academic year, approx 9 months)

**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.

**Measure:** Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

**Time Frame:** Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)

**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.

**Measure:** Dimensional Change Card Sort - NIH Toolbox

**Time Frame:** Baseline to End of Intervention (up to end of academic year, approx 9 months)

#### Primary Outcomes

**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.

**Measure:** Classroom Behavior

**Time Frame:** Baseline to End of Intervention (up to end of academic year, approx 9 months)

**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.

**Measure:** Adaptive Behavior (at follow-up)

**Time Frame:** Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)

#### Secondary Outcomes

**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.

**Measure:** Adaptive Behavior (end of intervention)

**Time Frame:** Baseline, End of Intervention (up to end of academic year, approx 9 months)

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 22 Years

**Minimum Age:** 14 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rockville

**Country:** United States

**Facility:** Center for Autism Spectrum Disorders, Children's National Hospital

**State:** Maryland

**Zip:** 20850

#### Overall Officials

**Official 1:**

**Affiliation:** Children's Research Institute, Children's National Hospital

**Name:** Cara Pugliese, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Request login access to NDA data

**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:** YES

**Time Frame:** Descriptive/raw de-identified data will be reported semi-annually through NDA.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002659

- Term: Child Development Disorders, Pervasive

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4623

- Name: Autistic Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M206

- Name: Autism Spectrum Disorder

- Relevance: HIGH

- As Found: Autism Spectrum Disorder

- ID: M5903

- Name: Child Development Disorders, Pervasive

- Relevance: LOW

- As Found: Unknown

- ID: M5902

- Name: Developmental Disabilities

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000067877

- Term: Autism Spectrum Disorder

### Misc Info Module

- Version Holder: 2024-05-24
