Girls in Transition Study: Helping Girls Enter the Teenage Years (GT)

March 17, 2008 updated by: Swarthmore College
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gender differences in rates of depression emerge during adolescence. Although rates of depression increase for both boys and girls during adolescence, the increase is more dramatic for girls. By late adolescence, girls are twice as likely as boys to develop depression. Because the transition to adolescence has been identified as a period of increased risk for girls, preventive interventions targeting early adolescent girls may promote resilience and prevent depression. The Girls in Transition (GT) program is a group intervention for 6th through 8th grade girls and is designed to address risk factors that are specific to girls. This study evaluates the effectiveness of the GT intervention in promoting coping strategies, preventing symptoms of depression and anxiety, and providing benefits in other outcomes related to depression, such as self-image.

Adolescents in this study will be assigned to one of two conditions: a group that will participate in the GT program in Spring 2006 (GT #1), or a waitlist control group that will participate in the GT program approximately two years later (GT #2). Students who participate in the program will attend eleven 90-minute after-school sessions led by the investigators. In the GT program, students learn cognitive-behavioral skills (such as strategies to cope with emotions and negative thinking) and problem-solving skills (such as assertiveness), and they discuss societal messages about women's appearance and roles. Adolescent participants will complete questionnaires about coping strategies, self-image, and feelings of hopelessness, depression and anxiety at five points during the study: at the beginning of the study (baseline) and at follow-ups approximately 6, 12, 16, and 24 months after baseline. In addition, students will complete an interview at baseline and then again 12 months later about experiences in which they have coped with stressful situations. Parents will complete a questionnaire about their child's life events at three assessment points (baseline and at follow-ups approximately 12 and 24 months after baseline).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Swarthmore, Pennsylvania, United States, 19081
        • Swarthmore College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Male

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Girls in Transition (GT) program
Behavioral: Girls in Transition (GT) program
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.
Other Names:
  • GT #1
Other: 2
Waitlist control
Behavioral: Waitlist Control
Participants in the waitlist control group will complete the GT program during the third year of the study.
Other Names:
  • GT #2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adolescents' coping strategies by self-report
Time Frame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Adolescents' depressive symptoms by self-report
Time Frame: Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline
Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Adolescents' symptoms of anxiety by self-report
Time Frame: Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline
Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline
Adolescents' feelings of hopelessness by self-report
Time Frame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Adolescents' perceptions of their physical appearance by self-report
Time Frame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swarthmore College

Collaborators

University of Pennsylvania

Investigators

  • Principal Investigator: Jane E. Gillham, Ph.D., Swarthmore College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Anticipated)

June 1, 2008

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

March 24, 2008

Last Update Submitted That Met QC Criteria

March 17, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 803680

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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