- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04015856
Preventing Early Child Marriage in Nepal
Impact Evaluation of the Tipping Point Project in Nepal: An Intervention to Prevent Early Child Marriage
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Each year, child marriage, before age 18 years, affects more than 10 million girls globally. The practice is associated with adverse maternal and child health outcomes and diminished long-term economic empowerment. About half of all child marriages occur in South Asia. A recent study in four high prevalence South Asian countries showed declines in girl-child marriage from 1991-1994 to 2005-2007, however, these declines were concentrated in the youngest ages. Namely, significant relative reductions occurred in the marriage of girls before age 14 years in all countries, however, little or no change was seen in the marriage of 16- to 17-year-old girls for any country except Bangladesh, where the prevalence of such marriages increased.
Tipping Point (TP) is an innovative program developed by Cooperative for Assistance and Relief Everywhere, Inc. (CARE) to change community social norms and build capacity among adolescent girls to become agents of change in their communities, with the ultimate goal of reducing the risk of child marriage.
The quantitative evaluation of the TP package will involve a three arm Cluster Randomized Controlled Trial (CRCT), where the arms are as follows:
- Arm 1: Full TP intervention including emphasized social norms change
- Arm 2: Light TP intervention without emphasized social norms change
- Arm 3: Pure control
The overall evaluation in Nepal will start with the baseline study, followed by eighteen months of interventions. After the intervention phase, there will be a one year 'freeze' period, when no interventions will take place. After that one year, the end-line evaluation study will be conducted in Nepal to assess the impact of the packages.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kathmandu, Nepal, 44600
- Interdisciplinary Analysts
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Clusters
- marginalized communities based on CARE Nepal formula
- communities prioritized by Nepal Government
- no concurrent non-governmental organization (NGO) programming
- no concurrent CARE programming
Inclusion Criteria for Boys and Girls (invited to participate in the intervention, survey, in-depth interviews, focus group discussions)
- unmarried
- age 12 -under 17
- living in study community
- no plans to migrate in subsequent 24 months
Inclusion Criteria for Mothers and Fathers of Selected Boys and Girls (invited to intervention and focus group discussions)
- male and female parental figures of an adolescent who has been recruited to participate in the intervention and associated measurement
Exclusion Criteria for Mothers and Fathers of Selected Boys and Girls:
- none
Inclusion Criteria for Community Adults:
- at least 25 years of age
- living in one of the study Communities
- no plans to migrate during the next two years
Exclusion Criteria for Community Adults:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Full TP intervention including emphasized social norms change
Participants in this study arm will receive the full TP intervention, including emphasized social norms change, for 18 months.
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CARE's Tipping Point initiative focuses on addressing the root causes of child, early, and forced marriage (CEFM) and promoting the rights of adolescent girls through community-level programming and evidence generation in Nepal and Bangladesh, as well as multi-level advocacy and cross-learning efforts across the globe.
Tipping Point's approach focuses on synchronized engagement with different participant groups-including adolescent girls, adolescent boys, parents/community members, community leaders-around key programmatic pillars, and creates public spaces for all community members to engage in the dialogue.
Tipping Point's approach relies on challenging social expectations and repressive gender norms and promoting girl-centric and girl-led activism to enable adolescent girls to identify and move into social spaces where they can challenge inequality.
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Active Comparator: Light TP intervention without emphasized social norms change
Participants in this study arm will receive the light TP intervention, without emphasized social norms change, for 18 months
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The Tipping Point project also has designed a social norms light package, which includes a subset of the social norms and activism components of the full package.
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No Intervention: Control
The control group will not have any study interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in proportion of never married adolescents
Time Frame: Baseline, Month 30
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The proportion of never-married adolescents (aged under 20) in each study arm will be examined.
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Baseline, Month 30
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Change in proportion of married adolescents
Time Frame: Baseline, Month 30
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The proportion of married adolescents (aged under 20) in each study arm will be examined.
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Baseline, Month 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in decision making
Time Frame: Baseline, Month 30
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Qualitative questions on gender and rights will assess awareness of rights, progressive choices, negotiation skills, and decision making of adolescent girls.
Information will be collected during interviews asking open ended questions.
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Baseline, Month 30
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Change in Adolescent Sexual and Reproductive Health and Rights (ASRHR)
Time Frame: Baseline, Month 30
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Qualitative questions on ASRHR will assess the knowledge, progressive attitudes and practice of sexual and reproductive health rights among adolescent girls.
Information will be collected during interviews asking open ended questions.
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Baseline, Month 30
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Change in social norms
Time Frame: Baseline, Month 30
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Qualitative questions on social norms change will assess to what extent the beliefs have shifted in the community regarding what others do in terms of gender, rights (including ASRHR) and child, early and forced marriage (CEFM) and what others expect them to do in terms of gender, rights (including ASRHR) and CEFM.
Information will be collected during interviews asking open ended questions.
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Baseline, Month 30
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Change in movement building among adolescent girls
Time Frame: Baseline, Month 30
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Qualitative questions on girl-centered movement building will assess the cohesion, solidarity, leadership and mobilization skills of adolescent girls, as well as the adolescent girls' autonomous engagement with different networks, the community and government and non-government stakeholders.
Information will be collected during interviews asking open ended questions.
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Baseline, Month 30
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Change in gender attitudes among community adults
Time Frame: Baseline, Month 30
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Adults in the intervention communities will complete a 42-item questionnaire about gender attitudes.
The instrument includes the domains of gender roles, roles of girls and women, manhood and masculinity, controlling behaviors, and attitudes condoning violence against girls.
Responses are given on a scale from 1 to 4 where 1 = fully agree and 4 = fully disagree.
Summed scores range from 42 to 168, where higher scores indicate greater change in social norms.
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Baseline, Month 30
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Change in attitudes on ASRHR among community adults
Time Frame: Baseline, Month 30
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Adults in the intervention communities will complete a 16-item questionnaire about ASRHR attitudes.
Responses are given on a scale from 1 to 4 where 1 = fully agree and 4 = fully disagree.
Summed scores range from 16 to 64, where higher scores indicate greater change in social norms.
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Baseline, Month 30
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00109419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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