NCT01220635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

October 5, 2010

Last Update Submit

February 13, 2014

Conditions

Depression

Keywords

Depressive SymptomsDepression preventionAdolescentsSchool-Based ServicesHealth Behavior

Outcome Measures

Primary Outcomes (1)

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

    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.

    up to 1 year

Secondary Outcomes (5)

  • Parent-Child Communication (PCC; child and parent version)

    up to 1 year

  • Behavioral Assessment System for Children-2nd Edition (BASC-2; student, parent, & teacher version)

    up to 1 year

  • Health Enhancing Behavior Index (HEBI)

    up to 1 year

  • Service Use Interview (Service for Children and Adolescence Parent Interview-modified)

    up to 1 year

  • Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS)

    up to 1 year

Study Arms (2)

Skill Group Program

EXPERIMENTAL

Positive Thoughts and Actions Program

Behavioral: Positive Thoughts and Actions Program

Individual Support Program

ACTIVE COMPARATOR

Measure of Adolescent Potential for Suicide (MAPS) - modified

Behavioral: Individual Support Program

Interventions

Positive Thoughts and Actions ProgramBEHAVIORAL

Students in the skills group will attend a 12-session (50 minutes each), 12-week program with 4-6 other students. The skills group will take place at school during school hours. Parents in the skill group will be asked to participate in two parent group workshops to take place at their child's school or other participating middle school (2-hours each). In addition, the skill group leader will conduct two individual family meetings with the student and parent(50 minutes each).

Skill Group Program
Individual Support ProgramBEHAVIORAL

Students will be individually interviewed (60-90 minutes) at school to review areas of stress and support. The health professional conducting the interview will reinforce the student's strengths, and provide connections to sources of help from caring adults at home and at school. Parents will be called following the assessment to help the family locate appropriate resources if needed (e.g., tutoring resources, school counselor).

Individual Support Program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's

Seattle, Washington, 98115, United States

Location

Related Publications (1)

  • Duong MT, Kelly BM, Haaland WL, Matsumiya B, Huey SJ Jr, McCarty CA. Mediators and Moderators of a School-Based Cognitive-Behavioral Depression Prevention Program. Cognit Ther Res. 2016 Oct;40(5):705-716. doi: 10.1007/s10608-016-9780-2. Epub 2016 Apr 28.

    PMID: 27795599DERIVED

MeSH Terms

Conditions

DepressionHealth Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Carolyn A McCarty, Ph.D.

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 14, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations

US(1)