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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Swarthmore College.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by:
Swarthmore College
ClinicalTrials.gov Identifier:
NCT00641940
First received: March 17, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Swarthmore College:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Male
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641940

Locations
United States, Pennsylvania
Swarthmore College
Swarthmore, Pennsylvania, United States, 19081
Sponsors and Collaborators
Swarthmore College
University of Pennsylvania
Investigators
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 August 28, 2014