Clinical trial NCT00641940: Girls in Transition Study: Helping Girls Enter the Teenage Years
Official title: Girls in Transition Study: Helping Girls Enter the Teenage Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Depression
Anxiety
Keywords: Prevention
Girls
Resilience
Lead sponsor: Swarthmore College
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2008-03-24
Enrollment: 32
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Male

Primary outcomes:
measure: Adolescents' coping strategies by self-report
timeFrame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
measure: Adolescents' depressive symptoms by self-report
timeFrame: 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
timeFrame: Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline
measure: Adolescents' feelings of hopelessness by self-report
timeFrame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
measure: Adolescents' perceptions of their physical appearance by self-report
timeFrame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Other outcomes:
Locations:
city: Swarthmore
country: United States
facility: Swarthmore College
state: Pennsylvania
Study officials:
affiliation: Swarthmore College
name: Jane E. Gillham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: