Girls in Transition Study: Helping Girls Enter the Teenage Years (GT)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Anxiety |
Behavioral: Girls in Transition (GT) program Behavioral: Waitlist Control |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Girls in Transition Study: Helping Girls Enter the Teenage Years |
- Adolescents' coping strategies by self-report [ Time Frame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline ] [ Designated as safety issue: No ]
- Adolescents' depressive symptoms by self-report [ Time Frame: Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline ] [ Designated as safety issue: No ]
- Adolescents' symptoms of anxiety by self-report [ Time Frame: Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline ] [ Designated as safety issue: No ]
- Adolescents' feelings of hopelessness by self-report [ Time Frame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: GT #1
|
|
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 Name: GT #2
|
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).
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Female
- Student in grades 6 through 8
- Student in participating school
Exclusion Criteria:
- Male
Contacts and Locations| United States, Pennsylvania | |
| Swarthmore College | |
| Swarthmore, Pennsylvania, United States, 19081 | |
| Principal Investigator: | Jane E. Gillham, Ph.D. | Swarthmore College |
More Information
No publications provided
| Responsible Party: | Jane E. Gillham, Ph.D., Swarthmore College |
| ClinicalTrials.gov Identifier: | NCT00641940 History of Changes |
| Other Study ID Numbers: | 803680 |
| Study First Received: | March 17, 2008 |
| Last Updated: | March 17, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Swarthmore College:
|
Prevention Girls Resilience |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder |
Mental Disorders Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 21, 2013