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

Primary Purpose

Autism Spectrum Disorder, Mental Health Disorder, Executive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unstuck and on Target (UOT)
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Therapists:

  1. Employed as staff or a trainee at participating clinic (publicly-funded mental health program)
  2. Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months).
  3. Has an eligible client on current caseload (see below).

Inclusion Criteria for Child Participants

  1. Child age 5-13 years.
  2. Has a current ASD diagnosis on record.
  3. English or Spanish speaking.

Exclusion Criteria for Child/ Parent Participants

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

Sites / Locations

  • Child and Adolescent Services Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

UOT Training

Arm Description

Community therapists delivering routine care to participant children with no training in UOT

Therapists enrolled in UOT Training

Outcomes

Primary Outcome Measures

Acceptability of Intervention Measure
The Acceptability of Intervention Measure (AIM) measure includes five items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale, 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 UOT will complete this measure.
Intervention Appropriateness Measure
The Intervention Appropriateness Measure (IAM) measure includes five items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale, 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 UOT will complete these measures.
Feasibility of Intervention Measure
The Feasibility of Intervention Measure (FIM) measure includes five items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale, 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 UOT will complete these measures.
Provider Fidelity- Change since baseline in provider fidelity
Provider adherence or fidelity to the UOT intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the UOT intervention. Observers rate the provider's use of UOT on 10 components, using a 5-point Likert scale with a minimum score of 10 and maximum score of 50. Changes in provider fidelity since baseline will be examined.

Secondary Outcome Measures

Eyberg Child Behavior Inventory- Change since baseline in child behaviors
The Eyberg Child Behavior Inventory (ECBI) is a parent-report measure of child behavior. Performance is represented as a T scores (mean=50; SD=10), with higher scores indicating higher scores indicating more problem behaviors. Previous trials examining mental health interventions for youth with ASD demonstrated improvements in child behavior, the primary presenting problem in mental health settings, as a result of effective mental health interventions. Caregivers of youth will complete this measure.

Full Information

First Posted
February 27, 2020
Last Updated
March 3, 2020
Sponsor
San Diego State University
Collaborators
Rady Children's Hospital, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04295512
Brief Title
Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services
Official Title
Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
Rady Children's Hospital, San Diego

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
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.
Detailed Description
This project will examine the implementation and effectiveness of an ASD executive functioning intervention, entitled Unstuck and On Target (UOT), adapted for use in community mental health clinics. Minimizing the impact of executive functioning deficits in youth has broad public health implications, including improving the effectiveness of mental health services for youth such as those with autism spectrum disorders (ASD) and attention-deficit/hyperactivity disorder (ADHD). Improved executive functioning also has the potential for improvement in real-world functioning, including daily living skills, mental health, and educational outcomes. Although UOT is an established evidence-based intervention, the effectiveness of this intervention in mental health settings has not been established. Therefore, the primary aim is to collect data on implementation outcomes of the adapted intervention, including feasibility, utility, and therapist fidelity, in mental health settings. The secondary aim is to collect data on the preliminary effectiveness of UOT adapted for mental health settings. This study has the potential to make a significant impact by building local capacity to serve school-age children with executive functioning deficits in routine service settings, and advancing the science on the effectiveness of an established evidence-based practice (UOT) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Mental Health Disorder, Executive Dysfunction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Community therapists delivering routine care to participant children with no training in UOT
Arm Title
UOT Training
Arm Type
Experimental
Arm Description
Therapists enrolled in UOT Training
Intervention Type
Behavioral
Intervention Name(s)
Unstuck and on Target (UOT)
Intervention Description
Unstuck and on Target (UOT) is a cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. UOT 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. UOT will be adapted for use in mental health service settings. Mental health therapists will be trained in UOT and deliver to youth and caregivers.
Primary Outcome Measure Information:
Title
Acceptability of Intervention Measure
Description
The Acceptability of Intervention Measure (AIM) measure includes five items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale, 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 UOT will complete this measure.
Time Frame
6 months post enrollment/post intervention implementation
Title
Intervention Appropriateness Measure
Description
The Intervention Appropriateness Measure (IAM) measure includes five items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale, 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 UOT will complete these measures.
Time Frame
6 months post enrollment/post intervention implementation
Title
Feasibility of Intervention Measure
Description
The Feasibility of Intervention Measure (FIM) measure includes five items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale, 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 UOT will complete these measures.
Time Frame
6 months post enrollment/post intervention implementation
Title
Provider Fidelity- Change since baseline in provider fidelity
Description
Provider adherence or fidelity to the UOT intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the UOT intervention. Observers rate the provider's use of UOT on 10 components, using a 5-point Likert scale with a minimum score of 10 and maximum score of 50. Changes in provider fidelity since baseline will be examined.
Time Frame
Fidelity will be measured monthly from study enrollment to 6 months post enrollment.
Secondary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory- Change since baseline in child behaviors
Description
The Eyberg Child Behavior Inventory (ECBI) is a parent-report measure of child behavior. Performance is represented as a T scores (mean=50; SD=10), with higher scores indicating higher scores indicating more problem behaviors. Previous trials examining mental health interventions for youth with ASD demonstrated improvements in child behavior, the primary presenting problem in mental health settings, as a result of effective mental health interventions. Caregivers of youth will complete this measure.
Time Frame
Study Enrollment and 6 months post study enrollment
Other Pre-specified Outcome Measures:
Title
Wechsler Abbreviated Scale of Intelligence Block Design - Change in Nonverbal Reasoning
Description
The Wechsler Abbreviated Scale of Intelligence Block Design (WASI BD) subtest is a timed visual construction task that requires efficient nonverbal cognitive problem solving. Performance is represented as T scores (mean=50; SD=10), with higher scores indicating better performance. A previous trial showed significant improvements in performance as a result of treatment with UOT.
Time Frame
Study Enrollment and 6 months post study enrollment
Title
The Challenge Task - Change in flexibility
Description
The Challenge Task is a published, normed measure designed by the UOT creators to measure the functional outcome of executive functioning skills in socially relevant situations in a standardized way. Specific challenges are posed and the child's flexibility and planning 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 (e.g. for the sculpture task described above, a flexibility score of 2 is assigned if: "The participant is unwilling to switch sculptures...").
Time Frame
Study Enrollment and 6 months post study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Therapists: 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). Inclusion Criteria for Child Participants Child age 5-13 years. Has a current ASD diagnosis on record. English or Spanish speaking. Exclusion Criteria for Child/ Parent Participants 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey S Dickson, Ph.D.
Phone
858-966-7703
Ext
246907
Email
kdickson@sdsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tana Holt, B.A.
Phone
858 966 7703
Email
tholt@sdsu.edu
Facility Information:
Facility Name
Child and Adolescent Services Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Dickson, Ph.D.
Phone
858-966-7703
Ext
246907
Email
kdickson@sdsu.edu
First Name & Middle Initial & Last Name & Degree
Kelsey S Dickson, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32699642
Citation
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.
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Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services

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