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

Primary Purpose

Anxiety, Depression, Trauma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Monitoring and Feedback System

Treatment as usual

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, depression, trauma, behavior problems, evidence-based treatments, manualized treatments, cognitive-behavioral therapy, youth, mental health, self-regulation, neuroimaging

Eligibility Criteria

7 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress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

Sites / Locations

Harvard University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Child STEPS

Usual Care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change from Baseline Emotion Regulation Task at End of Treatment

Change from Baseline Emotional Go/No-Go Task at End of Treatment

Secondary Outcome Measures

Change from Baseline Attentional Bias Task at End of Treatment

Change from Baseline Granularity Task at End of Treatment

Change from Baseline Behavior Rating Inventory of Executive Function (BRIEF) at End of Treatment

Change from Baseline Early Adolescent Temperament Questionnaire Revised (EATQ-R) at End of Treatment

Full Information

NCT ID

NCT03112265

First Posted

March 28, 2017

Last Updated

March 8, 2021

Sponsor

Harvard University

1. Study Identification

Unique Protocol Identification Number

NCT03112265

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

July 31, 2020 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Harvard University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression, Trauma, Behavior Problems

Keywords

anxiety, depression, trauma, behavior problems, evidence-based treatments, manualized treatments, cognitive-behavioral therapy, youth, mental health, self-regulation, neuroimaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Child STEPS

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

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

Other Intervention Name(s)

MATCH, MATCH - ADTC

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Monitoring and Feedback System

Other Intervention Name(s)

MFS

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Treatment as usual

Other Intervention Name(s)

Usual Care, UC

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline Emotion Regulation Task at End of Treatment

Time Frame