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NCT Number: NCT06651086

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

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Emotional Regulation Executive Functioning Mental Disorders Neurodevelopmental Disorders Self-Control Social Behavior

Age range

6 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unstuck and On Target

Behavioral

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.

Unified Protocol for Children

Behavioral

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).

Primary outcomes

  1. Changes in Child Mental Health Symptoms

    Time frame: Pre-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.

  2. Externalizing Behaviors

    Time frame: Pre-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.

  3. Evidence-based Intervention Fidelity

    Time frame: During 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.

  4. Evidence-Based Intervention Training Engagement

    Time frame: 6-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).

Secondary outcomes

  1. Evidence-Based Intervention Reach

    Time frame: 6-months post-EBI implementation, 12-month follow-up after EBI implementation, 18-month follow-up after EBI implementation

    Therapists 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.

  2. Psychotherapy Quality

    Time frame: 6-months post-EBI implementation

    Therapists 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.

Other outcomes

  1. Clinical Mediator: Changes in Executive Functioning, BRIEF-II

    Time frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation

    Changes in executive functioning will be examined using several measures of executive functioning, including the Brief Rating Inventory of Executive Function-2nd Edition (BRIEF-II)- Parent Report, a 63-item rating scale supported by RDoC Working Group that measures real-world EF skills. This measure was shown to be sensitive to change in prior Unstuck trials, including PI's feasibility trial.

  2. Clinical Mediator: Changes in Executive Functioning, EFCT

    Time frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation

    Changes in executive functioning will be examined using several measures of executive functioning, including the Executive Function Challenge Task (EFCT), a standardized, semi-structured assessment of real-world EF abilities. This measure was shown to be sensitive to change in prior Unstuck trials, including PI's feasibility trial.

  3. Clinical Mediator: Changes in Executive Functioning, DCCS

    Time frame: Pre-EBI implementation, 6-months post-EBI implementation, 12-month follow-up after EBI implementation

    Changes in executive functioning will be examined using several measures of executive functioning, including the NIH toolbox Dimensional Change Card Sort test (DCCS), a standard, lab-based task for assessing cognitive flexibility. This measure was shown to be sensitive to change in prior Unstuck trials, including PI's feasibility trial.

  4. Clinical Mediator: Changes in Emotion Regulation

    Time frame: Pre-EBI implementation, 6-months post-EBI training, 12-month follow-up after EBI implementation

    Changes in Emotion Regulation will be examined using the Emotion Dysregulation Inventory (EDI), a 30-item parent-report ratings scale measuring emotion regulation.

  5. Implementation Mediator: Changes in Intervention Perceptions of Fit, PCIS

    Time frame: Pre-EBI implementation, 6-months post-EBI implementation

    Changes in perceptions of fit regarding the evidence-based intervention will be examined using the Perceived Characteristics of Intervention Scale (PCIS), a 20-item measure assessing perceptions towards an intervention, including compatibility or fit.

  6. Implementation Mediator: Changes in Intervention Perceptions of Fit, IAM

    Time frame: Pre-EBI implementation, 6-months post-EBI implementation

    Changes in perceptions of fit regarding the evidence-based intervention will be examined using the Intervention Appropriateness Measure (IAM), a 4-item measure that assesses the appropriateness or fit of an intervention.

  7. Implementation Mediator: Changes in Autism Self-Efficacy and Knowledge, Confidence

    Time frame: Pre-EBI implementation, 6-months post-EBI implementation

    Changes in therapist autism self-efficacy and knowledge will be examined using the Therapist Confidence Scale for Autism Spectrum Disorder (TCS-ASD), a 14-item measure assessing confidence in psychotherapy for autistic clients.

  8. Implementation Mediator: Changes in Autism Self-Efficacy and Knowledge, Knowledge

    Time frame: Pre-EBI implementation, 6-months post-EBI implementation

    Changes in therapist autism self-efficacy and knowledge will be examined using the Therapist Knowledge for Autistic Clients, a 6-item measure of knowledge of mental health-related topics for autism (e.g., core symptoms, co-occurring problems).

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah E Reynolds, MPH

CONTACT

[email protected]

Kelsey S Dickson, PhD

CONTACT

[email protected]

858-966-7703 ext. 246907

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of California, San Diego
  • University of Colorado, Denver

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 21, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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