RecruitingNot ApplicableNCT06651086

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


Sponsor

San Diego State University

Enrollment

672 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 99 Years

Inclusion Criteria18

  • 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

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Interventions

BEHAVIORALUnstuck 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.

BEHAVIORALUnified 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).


Locations(2)

San Diego State University

San Diego, California, United States

University of Colorado - Anschutz

Aurora, Colorado, United States

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NCT06651086


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