NCT00641940

Brief Summary

This is a pilot study of the Girls in Transition (GT) program, an intervention designed to promote resilience and reduce gender-related risk factors for depression. The goal of the study is to gather preliminary data on the effects of the GT program.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Oct 2005

Typical duration for phase_1 depression

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

March 24, 2008

Status Verified

March 1, 2008

Enrollment Period

2.7 years

First QC Date

March 17, 2008

Last Update Submit

March 17, 2008

Conditions

Keywords

PreventionGirlsResilience

Outcome Measures

Primary Outcomes (2)

  • Adolescents' coping strategies by self-report

    Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline

  • Adolescents' depressive symptoms by self-report

    Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline

Secondary Outcomes (3)

  • Adolescents' symptoms of anxiety by self-report

    Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline

  • Adolescents' feelings of hopelessness by self-report

    Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline

  • Adolescents' perceptions of their physical appearance by self-report

    Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline

Study Arms (2)

1

EXPERIMENTAL

Girls in Transition (GT) program

Behavioral: Girls in Transition (GT) program

2

OTHER

Waitlist control

Behavioral: Waitlist Control

Interventions

In the 11-session after-school GT program, girls learn cognitive and behavioral skills related to intrapersonal, interpersonal, and social/contextual risk factors for depression.

Also known as: GT #1
1

Participants in the waitlist control group will complete the GT program during the third year of the study.

Also known as: GT #2
2

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Student in grades 6 through 8
  • Student in participating school

You may not qualify if:

  • Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swarthmore College

Swarthmore, Pennsylvania, 19081, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Jane E. Gillham, Ph.D.

    Swarthmore College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

October 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 24, 2008

Record last verified: 2008-03

Locations