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
: April 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 2018 |
Estimated Study Completion Date : | July 2018 |

Arm | Intervention/treatment |
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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).
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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:
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
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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.
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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:
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- 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 ]
- 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 ]
- 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 ]

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

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
Contact: John R. Weisz, PhD | john_weisz@harvard.edu |
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 |
Principal Investigator: | John R. Weisz, PhD | Harvard University |
Publications:
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: | April 13, 2017 |
Last Verified: | April 2017 |
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 |