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

Not Applicable

Completed

• Conditions: Anxiety; Behavior Problems; Trauma; Depression
• Interventions: Behavioral: Treatment as usual; Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems; Other: Monitoring and Feedback System

• Registration Number: NCT03112265
• Lead Sponsor: Harvard University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. enrolled in grades 3-7
2. have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
3. clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress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

1. Mental retardation
2. Pervasive developmental disorder
3. Eating disorder
4. children for whom attention problems or hyperactivity are the primary referral concern
5. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Treatment as usual	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.
Child STEPS	Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems	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).
Child STEPS	Monitoring and Feedback System	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).

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Harvard University; 🇺🇸 Cambridge, Massachusetts, United States