Recruiting

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

Sponsor:

San Diego State University

Code:

NCT06651086

Conditions

Autism Spectrum Disorder

Executive Functioning

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

Interventions

Unstuck and On Target

Unified Protocol for Children

Study Details

Brief 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.

Conditions

Autism Spectrum Disorder

Executive Functioning

Study ID

NCT06651086

Start date

Dec 15, 2024

Status verified date

Apr, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Study Design

Enrollment

672 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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).

Interventions

Unstuck and On Target

Unified Protocol for Children

Primary outcome measure

Changes in Child Mental Health Symptoms [ Time Frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation ]
Externalizing Behaviors [ Time Frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation ]
Evidence-based Intervention Fidelity [ Time Frame: During 6-month EBI implementation ]
Evidence-Based Intervention Training Engagement [ Time Frame: 6-months post-EBI implementation ]

Central Contacts and Locations

Central contacts

Kelsey S Dickson, PhD

858-966-7703 kdickson@sdsu.edu

Hannah E Reynolds, MPH

hreynolds@sdsu.edu

Locations

San Diego State University

Recruiting

San Diego, California, United States, 92182

Contacts

Kelsey S Dickson, PhD

858-966-7703 kdickson@sdsu.edu

Hannah E Reynolds, MPH

hreynolds@sdsu.edu

Principal Investigator:

Kelsey S Dickson, PhD

University of Colorado - Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sarah Kennedy, PhD

720-777-1234 sarah.kennedy@cuanschutz.edu

Hannah E Reynolds, MPH

hreynolds@sdsu.edu

Principal Investigator:

Sarah Kennedy, PhD

More Information

Sponsor

San Diego State University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

Autism spectrum disorder
executive functioning
emotion regulation
mental health symptoms
Unified Protcol for Children
Unstuck and On Target
evidence based intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by San Diego State University on 2026-04-20.