Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes

Study Overview
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Brief Summary
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The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.

Detailed Description
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This project will implement and evaluate the Child STEPs treatment approach as compared to treatment as usual (known as Usual Care or UC) through a randomized controlled trial (RCT) at eight K-8 public schools. The STEPs model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists to guide their selection and sequencing of the STEPs modules. The project will examine: (a) whether self-regulation skills at baseline are associated with baseline patterns of mental health and school problems; (b) whether self-regulation skills at baseline predict degree of improvement during treatment; (c) whether self-regulation skills improve from pre-to post treatment, and whether extent of this improvement differs by treatment condition; and (d) whether self-regulation improvement (from pre-to-post treatment) mediates the long-term benefit of treatment.

Official Title
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Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes

Conditions
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Behavior Problems, Anxiety, Depression, Trauma

Intervention / Treatment
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* Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems
* Other: Monitoring and Feedback System
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: enrolled in grades 3-7 have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress Disorder Reaction Index. Exclusion Criteria: Mental retardation Pervasive developmental disorder Eating disorder children for whom attention problems or hyperactivity are the primary referral concern active psychosis and/or a suicide attempt in the previous year To participate in the two neuroimaging tasks (Emotion Regulation Task; Emotional Go/No Go Task), participants must be healthy (no major medical illness), right-handed, fluent in English, have no history of neurological impairment (including but not limited to history of loss of consciousness for great than 20 minutes, seizures, stroke, etc.), have normal or corrected to normal vision, and have no contra-indications or risk factors for MRI research (such as braces or metal implants).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Child STEPS<br>Child STEPs includes (1) a treatment protocol, Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems (MATCH-ADTC), and (2) a youth monitoring and feedback system (MFS). | Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems<br>* MATCH-ADTC is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.<br>* Other names: MATCH - ADTC;Other: Monitoring and Feedback System<br>* For each child, the web-based MFS system provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Behavior and Emotions Survey and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all the weeks of treatment.<br>* Other names: MFS;|
| Active Comparator: Usual Care<br>Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective, and researchers will not influence their work. | Behavioral: Treatment as usual<br>* Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.<br>* Other names: UC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Emotion Regulation Task at End of Treatment |  | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | 
| Change from Baseline Emotional Go/No-Go Task at End of Treatment |  | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Attentional Bias Task at End of Treatment |  | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | 
| Change from Baseline Granularity Task at End of Treatment |  | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | 
| Change from Baseline Behavior Rating Inventory of Executive Function (BRIEF) at End of Treatment |  | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | 
| Change from Baseline Early Adolescent Temperament Questionnaire Revised (EATQ-R) at End of Treatment |  | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroimaging, anxiety, depression, trauma, behavior problems, evidence-based treatments, manualized treatments, cognitive-behavioral therapy, youth, mental health, self-regulation