NCT06651086 Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services
| NCT ID | NCT06651086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | San Diego State University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 672 participants |
| Start Date | 2024-12-15 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 672 participants in total. It began in 2024-12-15 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06651086 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 99 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06651086 currently recruiting?
Yes, NCT06651086 is actively recruiting participants. Contact the research team at kdickson@sdsu.edu for enrollment information.
Where is the NCT06651086 trial being conducted?
This trial is being conducted at San Diego, United States, Aurora, United States.
Who is sponsoring the NCT06651086 clinical trial?
NCT06651086 is sponsored by San Diego State University. The trial plans to enroll 672 participants.