Overview

This trial is active, not recruiting.

Conditions depression, anxiety
Treatments girls in transition (gt) program, waitlist control
Phase phase 1
Sponsor Swarthmore College
Collaborator University of Pennsylvania
Start date October 2005
End date June 2008
Trial size 32 participants
Trial identifier NCT00641940, 803680

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Girls in Transition (GT) program
girls in transition (gt) program GT #1
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)
Waitlist control
waitlist control GT #2
Participants in the waitlist control group will complete the GT program during the third year of the study.

Primary Outcomes

Measure
Adolescents' coping strategies by self-report
time frame: 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

Secondary Outcomes

Measure
Adolescents' symptoms of anxiety by self-report
time frame: 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
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

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Female - Student in grades 6 through 8 - Student in participating school Exclusion Criteria: - Male

Additional Information

Official title Girls in Transition Study: Helping Girls Enter the Teenage Years
Principal investigator Jane E. Gillham, Ph.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by Swarthmore College.