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

March 8, 2021 updated by: John Weisz, Harvard University
The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Harvard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
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
Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.
Other Names:
  • UC
  • Usual Care
Experimental: Child STEPS
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
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.
Other Names:
  • MATCH
  • MATCH - ADTC
Other: Monitoring and Feedback System
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.
Other Names:
  • MFS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Emotion Regulation Task at End of Treatment
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
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
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change over time from Day 1 to end of treatment, assessed up to 40 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Attentional Bias Task at End of Treatment
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Granularity Task at End of Treatment
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
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
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
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
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change over time from Day 1 to end of treatment, assessed up to 40 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Coping with Children's Negative Emotions Scale (CCNES) at End of Treatment
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Parenting Stress Index-Short Form (PSI-SF) at End of Treatment
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Family Adaptability and Cohesion Scale IV (FACES-IV) at End of Treatment
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change from Baseline Five Minute Speech Sample (FMSS) at End of Treatment
Time Frame: Change over time from Day 1 to end of treatment, assessed up to 40 weeks
Change over time from Day 1 to end of treatment, assessed up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard University

Investigators

  • Principal Investigator: John R. Weisz, PhD, Harvard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

March 28, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 313704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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