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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04295512
• Other study ID #: HS-2018-0147
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2020
• Source: San Diego State University
• Contact: Kelsey S Dickson, Ph.D.
• Phone: 858-966-7703
• Email: kdickson[@]sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: August 31, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Disease
• Executive Dysfunction
• Mental Disorders
• Mental Health Disorder

Intervention

Behavioral:
• Unstuck and on Target (UOT)
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.

Locations

Country	Name	City	State
United States	Child and Adolescent Services Research Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dickson, K.S., Aarons, G.A., Anthony, L.G., Kenworthy, L., Crandal, B., Williams, K., Brookman-Frazee, L. (under review). Adaption and pilot implementation of an executive functioning intervention in children's mental health services: A mixed-methods study protocol. Pilot and Feasibility Studies

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wechsler Abbreviated Scale of Intelligence Block Design - Change in Nonverbal Reasoning	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.	Study Enrollment and 6 months post study enrollment
Other	The Challenge Task - Change in flexibility	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...").	Study Enrollment and 6 months post study enrollment
Primary	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.	6 months post enrollment/post intervention implementation
Primary	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.	6 months post enrollment/post intervention implementation
Primary	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.	6 months post enrollment/post intervention implementation
Primary	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.	Fidelity will be measured monthly from study enrollment to 6 months post enrollment.
Secondary	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.	Study Enrollment and 6 months post study enrollment