Depression Clinical Trial
Official title:
Using Neuroimaging to Understand Children's Mental Health and Treatment Outcomes
NCT number | NCT03112265 |
Other study ID # | 313704 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | July 31, 2020 |
Verified date | March 2021 |
Source | Harvard University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 13 Years |
Eligibility | 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 clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-Traumatic Stress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). |
Country | Name | City | State |
---|---|---|---|
United States | Harvard University | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Harvard University |
United States,
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.
Weisz JR, Chorpita BF, Palinkas LA, Schoenwald SK, Miranda J, Bearman SK, Daleiden EL, Ugueto AM, Ho A, Martin J, Gray J, Alleyne A, Langer DA, Southam-Gerow MA, Gibbons RD; Research Network on Youth Mental Health. Testing standard and modular designs for psychotherapy treating depression, anxiety, and conduct problems in youth: a randomized effectiveness trial. Arch Gen Psychiatry. 2012 Mar;69(3):274-82. doi: 10.1001/archgenpsychiatry.2011.147. Epub 2011 Nov 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from Baseline Coping with Children's Negative Emotions Scale (CCNES) at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Other | Change from Baseline Parenting Stress Index-Short Form (PSI-SF) at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Other | Change from Baseline Family Adaptability and Cohesion Scale IV (FACES-IV) at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Other | Change from Baseline Five Minute Speech Sample (FMSS) at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Primary | Change from Baseline Emotion Regulation Task at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Primary | Change from Baseline Emotional Go/No-Go Task at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Secondary | Change from Baseline Attentional Bias Task at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Secondary | Change from Baseline Granularity Task at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Secondary | Change from Baseline Behavior Rating Inventory of Executive Function (BRIEF) at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks | ||
Secondary | Change from Baseline Early Adolescent Temperament Questionnaire Revised (EATQ-R) at End of Treatment | Change over time from Day 1 to end of treatment, assessed up to 40 weeks |
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