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

Primary Purpose

Depression, Anxiety

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Girls in Transition (GT) program
Waitlist Control
Sponsored by
Swarthmore College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Prevention, Girls, Resilience

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Male

Sites / Locations

  • Swarthmore College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Girls in Transition (GT) program

Waitlist control

Outcomes

Primary Outcome Measures

Adolescents' coping strategies by self-report
Adolescents' depressive symptoms by self-report

Secondary Outcome Measures

Adolescents' symptoms of anxiety by self-report
Adolescents' feelings of hopelessness by self-report
Adolescents' perceptions of their physical appearance by self-report

Full Information

First Posted
March 17, 2008
Last Updated
March 17, 2008
Sponsor
Swarthmore College
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00641940
Brief Title
Girls in Transition Study: Helping Girls Enter the Teenage Years
Acronym
GT
Official Title
Girls in Transition Study: Helping Girls Enter the Teenage Years
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2008 (Anticipated)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Swarthmore College
Collaborators
University of Pennsylvania

4. Oversight

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Prevention, Girls, Resilience

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Girls in Transition (GT) program
Arm Title
2
Arm Type
Other
Arm Description
Waitlist control
Intervention Type
Behavioral
Intervention Name(s)
Girls in Transition (GT) program
Other Intervention Name(s)
GT #1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Control
Other Intervention Name(s)
GT #2
Intervention Description
Participants in the waitlist control group will complete the GT program during the third year of the study.
Primary Outcome Measure Information:
Title
Adolescents' coping strategies by self-report
Time Frame
Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Title
Adolescents' depressive symptoms by self-report
Time Frame
Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline
Secondary Outcome Measure Information:
Title
Adolescents' symptoms of anxiety by self-report
Time Frame
Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline
Title
Adolescents' feelings of hopelessness by self-report
Time Frame
Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Student in grades 6 through 8 Student in participating school Exclusion Criteria: Male
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane E. Gillham, Ph.D.
Organizational Affiliation
Swarthmore College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swarthmore College
City
Swarthmore
State/Province
Pennsylvania
ZIP/Postal Code
19081
Country
United States

12. IPD Sharing Statement

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