Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services

NCT04295512 | Completed Results DMC

• 1 other identifier: HS-2018-0147
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to conduct a feasibility test of an ASD executive functioning intervention adapted for mental health settings, including examining the effectiveness and process of implementing this adapted intervention in community mental health programs.

Conditions

Autism Spectrum Disorder; Mental Health Disorder; Executive Dysfunction

Outcome Measures

Primary Outcomes (5)

• Acceptability of Intervention Measure

  The Acceptability of Intervention Measure (AIM) measure includes four items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher acceptability. This measure were designed to assess mental health providers' perceptions regarding acceptability of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

  6 months after starting implementation

• Intervention Appropriateness Measure

  The Intervention Appropriateness Measure (IAM) measure includes four items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher appropriateness. This measure was designed to assess mental health providers' perceptions regarding appropriateness of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

  6 months after starting implementation

• Feasibility of Intervention Measure

  The Feasibility of Intervention Measure (FIM) measure includes 4 items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher feasibility. This measure was designed to assess mental health providers' perceptions regarding feasibility of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

  6 months after starting implementation

• Average of Provider Fidelity Throughout Implementation Period

  Provider adherence or fidelity to the Unstuck and On Target intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the Unstuck and On Target intervention. Observers rate the provider's use of Unstuck and On Target on 9 components, using a 5-point (1 to 5) Likert scale, with higher scores indicating higher fidelity. For this report, a single, averaged value of all fidelity scores has been calculated per component.

  A single, averaged value of all fidelity scores has been calculated. Average fidelity represents scores over the course of 6 months of therapist implementation. Table rows represent different aspects of fidelity that were scored.

• Child Behavior Checklist

  Child Behavior Checklist (CBCL) is a parent-report measure of child problem behavior. The CBCL is divided into three broadband scales (Internalizing, Externalizing, and Total Problem Scores) and several associate subscale scores. For this study, only the broadband scales were utilized for analyses. Scores are represented as T-scores with a population mean of 50 with standard deviation of 10 and ranges from 30 (minimum) to 95 (maximum. Higher scores reflect more mental health symptoms. The values reported below represent the mean change in the T-scores from the Total, Internalizing, and Externalizing T-Scores from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in symptoms (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole.

  At baseline and 6 months post-implementation.

Secondary Outcomes (1)

• Eyberg Child Behavior Inventory

  At baseline and 6 months post-implementation.

Other Outcomes (3)

• Wechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale

  At baseline and 6 months post-implementation.

• Executive Functioning Challenge Task

  At baseline and 6 months post-implementation.

• Behavior Rating Inventory of Executive Function Second Edition

  At baseline and 6 months post-implementation.

Study Arms (2)

Usual Care

NO INTERVENTION

Community therapists delivering routine care to participant children with no training in Unstuck and on Target

Unstuck and on Target Training

EXPERIMENTAL

Therapists enrolled in Unstuck and on Target Training

Behavioral: Unstuck and on Target

Interventions

Unstuck and on Target BEHAVIORAL

Unstuck and on Target is a cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. Unstuck and on Target is the first contextually-based executive functioning treatment that targets flexibility, goal-setting and planning through a cognitive behavioral program centered on self-regulatory scripts that are consistently modeled and reinforced. Unstuck and on Target will be adapted for use in mental health service settings. Mental health therapists will be trained in Unstuck and on Target and deliver to youth and caregivers.

Unstuck and on Target Training

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Employed as staff or a trainee at participating clinic (publicly-funded mental health program)
• Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months).
• Has an eligible client on current caseload (see below).
• Child age 5-13 years.
• Has a current ASD diagnosis on record.
• English or Spanish speaking.

You may not qualify if:

• Child does not present with executive functioning deficits.
• Child does not meet criteria for ASD via case record, on the Autism Diagnostic Observation Scale or exhibit other clinical indicators of ASD

Sponsors & Collaborators

• San Diego State University: lead
• Rady Children's Hospital, San Diego: collaborator

Study Sites (1)

Child and Adolescent Services Research Center

San Diego, California, 92123, United States

Location

Related Publications (1)

• Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.

  PMID: 32699642 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Results Point of Contact

• Title: Kelsey Dickson
• Organization: San Diego State University

kdickson@sdsu.edu

(619) 594-5380

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 4, 2020
• Study Start: July 15, 2021
• Primary Completion: May 20, 2023
• Study Completion: May 31, 2023
• Last Updated: February 27, 2025
• Results First Posted: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)