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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01220635 |
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Date of registration:
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05/10/2010 |
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Primary sponsor: |
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Public title:
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Middle School Matters Study
MSM |
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Scientific title:
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Prevention of Depression Within Salient Adolescent Contexts |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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160 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01220635 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Carolyn A McCarty, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seattle Children's Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 7th and 8th grade students at 4 participating middle schools
- Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately
top 25%)
- No imminent plans to move or change to non-participating school
- At minimum 6th grade language skills
- Agree to participate in random assignment and research interviews
- One Parent/caregiver willing to complete research interviews
Exclusion Criteria:
- Student with past or current Major Depressive Disorder (MDD) or Probable MDD
- Students with parents who do not speak English or Spanish
- Students in concurrent treatment
- Students in self-contained classroom, or with cognitive delays, or emotional
behavioral problems that would preclude them from benefiting from the group or being
a good group member
- Parent not willing to complete research interviews
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
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Intervention(s)
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Behavioral: Individual Support Program
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Behavioral: Positive Thoughts and Actions Program
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Primary Outcome(s)
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Moods and Feelings Questionnaire (MFQ; child and parent version)
[Time Frame: up to 1 year]
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Secondary Outcome(s)
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Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)
[Time Frame: up to 1 year]
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Health Enhancing Behavior Index (HEBI)
[Time Frame: up to 1 year]
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Parent-Child Communication (PCC; child and parent version)
[Time Frame: up to 1 year]
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Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)
[Time Frame: up to 1 year]
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Service Use Interview (Service for Children and Adolescence Parent Interview-modified)
[Time Frame: up to 1 year]
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Secondary ID(s)
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5R34MH083076-03
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R34 MH083706
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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