DepressionPhase 1GTNCT00641940
Girls in Transition Study: Helping Girls Enter the Teenage Years
A Phase 1 study testing Girls in Transition (GT) program in people with Depression and Anxiety, run by Swarthmore College at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Girls in Transition (GT) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female
- Student in grades 6 through 8
- Student in participating school
Who cannot join
- Male
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Depression, Anxiety
- Being tested
- Girls in Transition (GT) program, Waitlist Control
- Keywords
- Prevention, Girls, Resilience
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girls in Transition (GT) programBehavioural
Also called 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.
Waitlist ControlBehavioural
Also called GT #2
Participants in the waitlist control group will complete the GT program during the third year of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Girls in Transition (GT) program Receives: Behavioral: Girls in Transition (GT) program |
| 2 | Other | Waitlist control Receives: Behavioral: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescents' coping strategies by self-report
Measured: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Adolescents' depressive symptoms by self-report
Measured: Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline
Secondary outcomes (3)
Adolescents' symptoms of anxiety by self-report
Measured: Measured at baseline and follow-ups approximately 6, 12, 16, and 24 months after baseline
Adolescents' feelings of hopelessness by self-report
Measured: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Adolescents' perceptions of their physical appearance by self-report
Measured: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startOct 2005
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swarthmore College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Investigators
- Jane E. Gillham, Ph.D., Principal investigator, Swarthmore College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641940
- Sponsor's protocol ID
- 803680
- Acronym
- GT
- Status last verified
- Mar 2008
- First submitted
- 17 Mar 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girls in Transition Study: Helping Girls Enter the Teenage Years
- ClinicalTrials.gov ID
- NCT00641940
- Acronym / sponsor ID
- GT / 803680
- Conditions
- Depression, Anxiety
- Keywords
- Prevention, Girls, Resilience
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swarthmore CollegeUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Girls in Transition (GT) programGirls in Transition (GT) program |
| 2 | Other | Behavioral: Waitlist ControlWaitlist control |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Student in grades 6 through 8
- Student in participating school
Key exclusion criteria (1 listed)
- Male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Girls in Transition (GT) programAlso: GT #1In the 11-session after-school GT program, girls learn cognitive and behavioral skills related to intrapersonal, interpersonal, and social/contextual risk factors for depression. | Behavioural | 1 |
| Waitlist ControlAlso: GT #2Participants in the waitlist control group will complete the GT program during the third year of the study. | Behavioural | 2 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane E. Gillham, Ph.D. principal investigator
Swarthmore College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Girls in Transition (GT) program in people with Depression and Anxiety, run by Swarthmore College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescents' coping strategies by self-report (time frame: Measured at baseline and follow-ups approximately 6, 12, and 24 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2008.