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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06651086
Enrollment
672
Registered
2024-10-21
Start date
2024-12-15
Completion date
2029-08-31
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Executive Functioning

Keywords

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

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.

Detailed description

Autism is a highly prevalent neurodevelopmental condition, affecting 1 in 36 youth. The annual cost in the U.S. of autism was $223 billion in 2020 and is estimated to rise to $589 billion by 2030. Outcomes are poor and care disparities and high rates of unmet service needs are common. Mental health services play a key role in caring for autistic youth. There have been efforts to develop evidence-based interventions (EBIs) with the potential to lessen the public health burden of autism. Yet, research indicates limited community EBI penetration. Several work gaps remain, including a focus on EBIs designed for community implementation and those addressing multilevel barriers impeding EBI use. There is an urgent need to focus on EBIs that improve mental health services for autism and optimize outcomes for this priority, complex population. Executive functioning (EF) is a potent mechanism underlying autism and commonly co-occurring mental health conditions. EF impairments (e.g., inflexibility, poor goal setting, poor planning) contribute to negative outcomes spanning multiple areas (e.g., academic, vocational, health). Our work underscores the impact of EF deficits on mental health services, including its transdiagnostic impact on the majority of children served in this setting and its role as a barrier to psychotherapy engagement and progress. EF is responsive to treatment, and mental health therapists cite a significant need and motivation for EF treatments, making EF EBIs highly relevant for community mental health settings. However, EF EBIs have not been widely used and tested in such settings. Autism EBIs, or those developed or adapted for autistic youth, have the potential to enhance mental health services, in addition to improving service quality for the populations targeted (e.g., autism). This is due to the specific components and strategies incorporated into the EBI to enhance its impact and fit. We propose a Hybrid Type 2 randomized trial examining the effectiveness and implementation of an autism EF EBI (Unstuck and On Target) in community mental health settings. Unstuck and On Target is a cognitive-behavioral EF intervention effective for autism. With NIMH funding (K23MH115100;), Unstuck and On Target were systematically adapted for and tested in mental health settings, with a pilot test suggesting its preliminary effectiveness, high fidelity, and use beyond autism. Findings have the potential to transform implementation and service quality for the high-priority population of autistic youth as well as youth generally. Aim 1. Evaluate the effectiveness and implementation of an autism EBI (Unstuck and On Target), relative to a non-autism transdiagnostic intervention (Unified Protocol for Children) for autistic youth. Aim 2. Evaluate mediators of EBI training effects to confirm engaged change mechanisms of clinical and implementation outcomes. Aim 3. Explore the generalized effects of EBI training on reach and improved psychotherapy quality with non-autistic youth.

Interventions

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).

Sponsors

San Diego State University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Diego
CollaboratorOTHER
University of Colorado, Denver
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Observational Coders Direct Assessor

Intervention model description

Participating mental health programs from California and Colorado will be randomized to one of two conditions: Unstuck and On Target training and Unified Protocol for Children training. Therapists will be recruited from each participating program and enrolled as a dyad with target children. Autistic children will be enrolled at the beginning of therapist participation and before intervention training. Non-autistic children will be enrolled after intervention training and implementation or approximately 6 months after therapist enrollment. Participating therapists and child clients served in those programs will receive the same condition as their enrolled program.

Eligibility

Sex/Gender
ALL
Age
6 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Child Mental Health SymptomsPre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementationChanges 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 implementationPrimary 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 implementationA 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 implementationTherapist 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).

Secondary

MeasureTime frameDescription
Evidence-Based Intervention Reach6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementationTherapists will report on evidence-based intervention (EBI) reach as operationalized by the number and types of clients (e.g., presenting problem, diagnostic profile) of clients treated with EBI, including specific components used. Measure was adapted from prior work and used in the PI's feasibility trial.
Psychotherapy Quality6-months post-EBI implementationTherapists will complete the Evidence-Based Practice Concordant Care Assessment-Therapist Report (ECCA). With funding from NIMH (R01MH100134; PI: Brookman-Frazee/Lau), ECCA was developed and validated as a pragmatic measure of evidence-based strategy delivery in psychotherapy sessions useful in indexing mental health quality of care. It has internal consistency and inter-rater reliability. Therapists will complete weekly regarding strategies within a given session with a participating client.

Countries

United States

Contacts

CONTACTKelsey S Dickson, PhD
kdickson@sdsu.edu858-966-7703
CONTACTHannah E Reynolds, MPH
hreynolds@sdsu.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026