Girls in Transition Study: Helping Girls Enter the Teenage Years

Depression Clinical Trial

— GT  

Official title:

Girls in Transition Study: Helping Girls Enter the Teenage Years

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00641940
• Other study ID #: 803680
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 17, 2008
• Last updated: March 17, 2008
• Start date: October 2005
• Est. completion date: June 2008

Study information

• Verified date: March 2008
• Source: Swarthmore College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female

• Student in grades 6 through 8

• Student in participating school

Exclusion Criteria:

• Male

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

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

Locations

Country	Name	City	State
United States	Swarthmore College	Swarthmore	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Swarthmore College	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adolescents' coping strategies by self-report		Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline	No
Primary	Adolescents' depressive symptoms by self-report		Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline	No
Secondary	Adolescents' symptoms of anxiety by self-report		Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline	No
Secondary	Adolescents' feelings of hopelessness by self-report		Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline	No
Secondary	Adolescents' perceptions of their physical appearance by self-report		Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline	No