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Clinical Trials/NCT01220635
NCT01220635
Completed
N/A

Prevention of Depression Within Salient Adolescent Contexts

Seattle Children's Hospital1 site in 1 country120 target enrollmentOctober 2010
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Seattle Children's Hospital
Enrollment
120
Locations
1
Primary Endpoint
Moods and Feelings Questionnaire (MFQ; child and parent version)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This study aims to evaluate the short-term and long-term efficacy of two preventative intervention approaches designed to support middle school youth.

Detailed Description

This study involve two parts: Part 1 entailed screening 7th and 8th graders from 4 public middle schools to identify students who may be showing moderate signs of stress. Students who score at the designated cutoff on a depression symptoms measure received a brief check-in to determine eligibility for the follow up randomized trial (Part 2). An "indicated" sample of 120 adolescents in the 7th and 8th grade and their caregivers were randomly assigned to a brief, Individual Support Program (ISP) comparison group or a Skills Group Program. Research interviews were conducted at multiple timepoints with students and caregivers, and teacher questionnaires were used to examine changes in outcome measures. Following completion of the intervention, all participants were followed for 12-months.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
October 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carolyn McCarty

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Moods and Feelings Questionnaire (MFQ; child and parent version)

Time Frame: up to 1 year

Depressive symptoms of the child are assessed on the MFQ. Youth completed the MFQ at all 4 timepoints, parent ratings of students symptoms were collected at baseline, post-intervention, and 12 month follow up.

Secondary Outcomes

  • Parent-Child Communication (PCC; child and parent version)(up to 1 year)
  • Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)(up to 1 year)
  • Health Enhancing Behavior Index (HEBI)(up to 1 year)
  • Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)(up to 1 year)
  • Service Use Interview (Service for Children and Adolescence Parent Interview-modified)(up to 1 year)

Study Sites (1)

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