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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

March 28, 2017
April 13, 2017
August 9, 2018
January 2015
July 2020   (Final data collection date for primary outcome measure)
  • 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 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 ]
Same as current
Complete list of historical versions of study NCT03112265 on ClinicalTrials.gov Archive Site
  • 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 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 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 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 ]
Same as current
  • 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 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 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 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 ]
Same as current
 
Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety
  • Depression
  • Trauma
  • Behavior Problems
  • 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
  • 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
  • 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).
    Interventions:
    • Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems
    • Other: Monitoring and Feedback System
  • 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.
    Intervention: Behavioral: Treatment as usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
Same as current
July 2020
July 2020   (Final data collection date for primary outcome measure)

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).

Sexes Eligible for Study: All
7 Years to 13 Years   (Child)
Yes
Contact: John R. Weisz, PhD john_weisz@harvard.edu
United States
 
 
NCT03112265
313704
Yes
Not Provided
Not Provided
John Weisz, Harvard University
Harvard University
Not Provided
Principal Investigator: John R. Weisz, PhD Harvard University
Harvard University
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP