Skip to main content
OpenTrials
Completed

NCT Number: NCT03112265

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard University

Cambridge, Massachusetts, 02138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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  • clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress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

Treatment and study plan

Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems

Behavioral

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

Monitoring and Feedback System

Other

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

Treatment as Usual

Behavioral

Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.

Other names: Usual Care, UC

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Harvard University

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2017
Registry last updated
Mar 10, 2021

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.

Published trials that share one or more normalized conditions with this study.