Clinical trial NCT04295512: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Mental Health Disorder
Executive Dysfunction
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Rady Children's Hospital, San Diego
First posted: 2020-03-04
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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, 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 Unstuck and On Target 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 Unstuck and On Target 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 (Unstuck and On Target) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/setting.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of Intervention Measure
timeFrame: 6 months after starting implementation
measure: Intervention Appropriateness Measure
timeFrame: 6 months after starting implementation
measure: Feasibility of Intervention Measure
timeFrame: 6 months after starting implementation
measure: Average of Provider Fidelity Throughout Implementation Period
timeFrame: 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.
measure: Child Behavior Checklist
timeFrame: At baseline and 6 months post-implementation.
Secondary outcomes:
measure: Eyberg Child Behavior Inventory
timeFrame: At baseline and 6 months post-implementation.
Other outcomes:
measure: Wechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale
timeFrame: At baseline and 6 months post-implementation.
measure: Executive Functioning Challenge Task
timeFrame: At baseline and 6 months post-implementation.
measure: Behavior Rating Inventory of Executive Function Second Edition
timeFrame: At baseline and 6 months post-implementation.
Locations:
city: San Diego
country: United States
facility: Child and Adolescent Services Research Center
state: California
Study officials:
References:
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.