Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This project aims to follow up on a prior project examining the impact of training therapists in an executive functioning intervention Unstuck and On Target (UOT) adapted for community mental health settings. Study aims are to test the clinical and implementation effectiveness of training mental health therapists in Unstuck and On Target, an executive functioning intervention, relative to Unified Protocol for Children, a transdiagnostic intervention for emotional disorders. This includes examining the implementation of Unstuck and associated outcomes (e.g., effective delivery, expanded use of Unstuck beyond autism, the feasibility of Unstuck) and impact on changes in child executive functioning and behaviors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 99
Healthy Volunteers: t
View:

‣ Mental Health Programs:

• Publicly-funded

• Providing outpatient or school-based psychotherapy services to children

• Have at least 8 mental health providers on staff

‣ Therapists:

• Employed as staff or trainee at a participating program

• Employed at the program for at least the next 12 months

• Providing psychotherapy services to children

• Has an eligible child on current caseload (see below)

‣ Autistic Child/Caregiver Participants (enrolled in a dyad with a participating therapist):

• Child age 6-12 years

• Receiving services from an enrolled therapist

• Documented or suspected\* autism diagnosis

⁃ In the event of suspected autism diagnosis, the presence of elevated autism symptoms on the Social Responsiveness Scale-2nd Edition or the Autism Diagnostic Observation Scale-2nd Edition

‣ Non-Autistic Child/Caregiver Participants (enrolled in a dyad with a participating therapist):

• Child age 6-12 years

• Receiving services from an enrolled provider

• No history of documented or suspected autism diagnosis

Locations
United States
California
San Diego State University
RECRUITING
San Diego
Colorado
University of Colorado - Anschutz
RECRUITING
Aurora
Contact Information
Primary
Kelsey S Dickson, PhD
kdickson@sdsu.edu
858-966-7703
Backup
Hannah E Reynolds, MPH
hreynolds@sdsu.edu
Time Frame
Start Date: 2024-12-15
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 672
Treatments
Active_comparator: Unstuck and On Target
Unstuck and on Target (Unstuck; Cannon et al., 2021) is a cognitive-behavioral, intervention designed to be feasibly delivered by teachers and school staff in the elementary school setting. It was adapted for and pilot-tested in outpatient mental health. Unstuck targets key executive functions, including flexibility, goal-setting, planning, and coping. Sessions include prescribed content and activities to facilitate guided practice and home extension activities to aid generalization beyond the therapeutic session. It includes both child- and caregiver-directed strategies. It has been shown effective for youth with autism and attention-deficit/hyperactivity disorder.
Active_comparator: Unified Protocol for Children
Unified Protocol for Children is a transdiagnostic, cognitive-behaviorally based treatment targeting shared core dysfunctions underlying emotional disorders, including distress intolerance and emotional dysregulation. It was developed by integrating cognitive-behavioral and mindfulness strategies and includes prescribed activities, in-vivo experiments, and home-extension components to promote generalization. It includes both child- and caregiver-directed strategies. In addition to its effectiveness for youth with emotional disorders, recent work supports its efficacy for youth with additional non-emotional disorders (e.g., externalizing challenges, irritability).
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego, National Institute of Mental Health (NIMH), University of Colorado, Denver
Leads: San Diego State University

This content was sourced from clinicaltrials.gov