Emotional WellbeingNCT02429661
Girls First - India (2013-2015)
A study testing Peer support groups in people with Emotional Wellbeing and Social Wellbeing, run by CorStone at 1 site in United States.
Trial summary
The purpose of this study is to determine the social, emotional, physical, and educational effects of Girls First, a combined resilience and adolescent health program, vs. its components and a control group, among adolescents in India. Read more about this study
- Who is it for?
- Ages 9 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Wellbeing, Social Wellbeing, Physical Wellbeing
- What is being tested?
- Peer support groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,592 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Mar 2015
- Phase
- Interventional
- 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 9 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled at schools or present at sites selected for study
- Must complete consent/assent process
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Girls First - India Evaluation (2013-2015)
The purpose of this study is to determine the social, emotional, physical, and educational effects of Girls First, a combined resilience and adolescent health program, vs. its components and a control group, among adolescents in India.
- Conditions
- Emotional Wellbeing, Social Wellbeing, Physical Wellbeing
- Being tested
- Peer support groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support groupsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| RC (Girls First Resilience Curriculum) | Experimental | The Girls First Resilience Curriculum is delivered in peer support groups of 12-15 students per group over 23 weekly 1-hour sessions. The curriculum draws from fields such as positive psychology, emotional competence/intelligence, and restorative practices, and aims to improve students' psychosocial assets and wellbeing. Receives: Behavioral: Peer support groups |
| HC (Girls First Health Curriculum) | Experimental | The Girls First Health Curriculum is delivered in peer support groups of 12-15 students per group over 21 weekly 1-hour sessions. The curriculum covers topics such as nutrition, sexual and reproductive health, clean water, hygiene, and common diseases, and aims to improve students' physical health and wellbeing. Receives: Behavioral: Peer support groups |
| RC+HC (Girls First) | Experimental | Girls First is a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC). Receives: Behavioral: Peer support groups |
| SC (School-as-usual control) | No intervention | Participants receive no intervention and attend school as they usually would. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial assets and wellbeing
Measured by self-report scales
Measured: Change from baseline, measured at program completion (average of 6 months)
Physical health and wellbeing
Measured by self-report questions
Measured: Change from baseline, measured at program completion (average of 6 months)
Secondary outcomes (1)
Educational wellbeing
Measured by self-report questions
Measured: Change from baseline, measured at program completion (average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional WellbeingStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 4,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- CorStone
- Sponsor type
- University, hospital or other
- Collaborators
- David and Lucile Packard Foundation, Gramin Evam Nagar Vikas Parishad (GENVP), Integrated Development Foundation Nepal
- Responsible party
- Sponsor
- Investigators
- John Peabody, MD, PhD, Principal investigator, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429661
- Sponsor's protocol ID
- 01-GF-IN-2013
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Leventhal KS, DeMaria LM, Gillham J, Andrew G, Peabody JW, Leventhal S. Fostering emotional, social, physical and educational wellbeing in rural India: the methods of a multi-arm randomized controlled trial of Girls First. Trials. 2015 Oct 26;16:481. doi: 10.1186/s13063-015-1008-3.
PubMed 26503139
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girls First - India Evaluation (2013-2015)
- ClinicalTrials.gov ID
- NCT02429661
- Acronym / sponsor ID
- 01-GF-IN-2013
- Conditions
- Emotional Wellbeing, Social Wellbeing, Physical Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,592 participants (actual)
- Lead sponsor
- CorStoneUniversity, hospital or other
- Collaborators
- David and Lucile Packard Foundation, Gramin Evam Nagar Vikas Parishad (GENVP), Integrated Development Foundation Nepal
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Apr 2015 (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.
The purpose of this study is to determine the social, emotional, physical, and educational effects of Girls First, a combined resilience and adolescent health program, vs. its components and a control group, among adolescents in India.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RC (Girls First Resilience Curriculum) | Experimental | Behavioral: Peer support groupsThe Girls First Resilience Curriculum is delivered in peer support groups of 12-15 students per group over 23 weekly 1-hour sessions. The curriculum draws from fields such as positive psychology, emotional competence/intelligence, and restorative practices, and aims to improve students' psychosocial assets and wellbeing. |
| HC (Girls First Health Curriculum) | Experimental | Behavioral: Peer support groupsThe Girls First Health Curriculum is delivered in peer support groups of 12-15 students per group over 21 weekly 1-hour sessions. The curriculum covers topics such as nutrition, sexual and reproductive health, clean water, hygiene, and common diseases, and aims to improve students' physical health and wellbeing. |
| RC+HC (Girls First) | Experimental | Behavioral: Peer support groupsGirls First is a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC). |
| SC (School-as-usual control) | No intervention | –Participants receive no intervention and attend school as they usually would. |
Who may qualify
- Ages
- 9 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Enrolled at schools or present at sites selected for study
- Must complete consent/assent process
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Peer support groups | Behavioural | HC (Girls First Health Curriculum), RC (Girls First Resilience Curriculum), RC+HC (Girls First) |
Primary outcome
Psychosocial assets and wellbeing
Time frame: Change from baseline, measured at program completion (average of 6 months)
Measured by self-report scales
Physical health and wellbeing
Time frame: Change from baseline, measured at program completion (average of 6 months)
Measured by self-report questions
1 secondary outcome
Educational wellbeing
Time frame: Change from baseline, measured at program completion (average of 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Derived from this study: PubMed 26503139Leventhal KS, DeMaria LM, Gillham J, Andrew G, Peabody JW, Leventhal S. Fostering emotional, social, physical and educational wellbeing in rural India: the methods of a multi-arm randomized controlled trial of Girls First. Trials. 2015 Oct 26;16:481. doi: 10.1186/s13063-015-1008-3.
Related trials for Emotional Wellbeing
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Recruiting
Body-Based and Mind-Based Regulation in Overweight and Obese Women
Overweight and/or Obesity
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
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.
John Peabody, MD, PhD principal investigator
QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support groups in people with Emotional Wellbeing and Social Wellbeing, run by CorStone 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 2 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: finished, as of the sponsor's last update on 29 Apr 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Psychosocial assets and wellbeing (time frame: Change from baseline, measured at program completion (average of 6 months)). 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?
On the ClinicalTrials.gov record for NCT02429661, which also lists 1 linked publication.
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 29 Apr 2015.