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

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ClinicalTrials.gov Identifier: NCT03112265
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
John Weisz, Harvard University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Trauma Behavior Problems Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems Other: Monitoring and Feedback System Behavioral: Treatment as usual Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes
Study Start Date : January 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: MFS
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:
  • Usual Care
  • UC


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112265


Contacts
Contact: John R. Weisz, PhD john_weisz@harvard.edu

Locations
United States, Massachusetts
Harvard University Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: John R. Weisz, PhD       john_weisz@harvard.edu   
Principal Investigator: John R. Weisz, PhD         
Sponsors and Collaborators
Harvard University
Investigators
Principal Investigator: John R. Weisz, PhD Harvard University
More Information
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Publications:
Chorpita, B.F., & Weisz, J.R. (2009). Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC). Satellite Beach, FL: PracticeWise, LLC.

Responsible Party: John Weisz, Professor and Primary Investigator, Harvard University
ClinicalTrials.gov Identifier: NCT03112265     History of Changes
Other Study ID Numbers: 313704
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Keywords provided by John Weisz, Harvard University:
mental health
anxiety
depression
trauma
behavior problems
evidence-based treatments
 manualized treatments
cognitive-behavioral therapy
youth
self-regulation
neuroimaging

Additional relevant MeSH terms:
Depression
Problem Behavior
Behavioral Symptoms