Study of Executive Functioning Interventions for Children's Mental Health
This study is looking at two different approaches to help children with mental health challenges, especially those with Autism Spectrum Disorder and difficulties with executive functioning (skills like planning and problem-solving). It's comparing "Unstuck and On Target," an intervention adapted for mental health settings, with "Unified Protocol for Children," which helps with emotional difficulties. The goal is to see how well these interventions work in real-world mental health programs and how they affect children's mental health symptoms and behaviors. The study plans to enroll 672 participants and is currently unclear about its recruitment status. Success will be measured by changes in children's mental health symptoms and behaviors, and how well the interventions are delivered.
- Study design
- This interventional study plans to enroll 672 participants. It is comparing two different behavioral interventions.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' mental health symptoms and behaviors will be followed for 12 months after the intervention is implemented.
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Hybrid Effectiveness-Implementation Trial of an Executive Functioning Intervention for Children's Mental Health Services
At a glance
Conditions
NCT06651086
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
San Diego State University
San Diego, Californiastudy coordinator listed
Recruiting
University of Colorado - Anschutz
Aurora, Coloradostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
What this trial measures
- Changes in Child Mental Health SymptomsPre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
Changes in mental health symptoms will be measured by the Child Behavior Checklist (CBCL), a 113-item rating scale measuring a range of mental health symptoms.
- Externalizing BehaviorsPre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation
Primary outcome measures include externalizing behaviors. The Eyberg Child Behavior Inventory (ECBI), a 36-item widely used rating scale, will measure these behaviors.
- Evidence-based Intervention FidelityDuring 6-month EBI implementation
A trained observer masked to evidence-based intervention (EBI) condition and time will assess EBI delivery during recorded sessions of participating therapist-client dyads. Unique fidelity forms with items corresponding to each EBI (Unstuck and On Target and Unified Protocol for Children) will be used. Items rate adherence (i.e., the degree to which key components are delivered as intended) and competence (responsiveness, engagement, skill). Items are rated on a 1-5 scale, with higher scores indicating better fidelity. Measures have internal consistencies and are shown to be sensitive to treatment effects.
- Evidence-Based Intervention Training Engagement6-months post-EBI implementation
Therapist evidence-based intervention (EBI) training engagement will be operationalized as adherence to training requirements, including participation in training/consultation (as rated by trainers) and training-related submissions (forms, materials).