Preventing Early Child Marriage in Nepal

Child Marriage Clinical Trial

Official title:

Impact Evaluation of the Tipping Point Project in Nepal: An Intervention to Prevent Early Child Marriage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015856
• Other study ID #: IRB00109419
• Status: Completed
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: January 4, 2022

Study information

• Verified date: February 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project evaluates an intervention designed to prevent early child marriage in Nepal. The intervention consists of community dialogues, activist trainings, and community organized activities aimed at transforming social norms around gender. There will be three groups within the study: one exposed to the full program, one exposed to a lighter version of the program, and one that has not been exposed to the program. The impact evaluation will consist of qualitative and quantitative methods that compare these three groups.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2828
• Est. completion date: January 4, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Marriage

Intervention

Behavioral:
• Full TP intervention
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.
• Light TP intervention
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.

Locations

Country	Name	City	State
Nepal	Interdisciplinary Analysts	Kathmandu

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Cooperative for Assistance and Relief Everywhere, Inc. (CARE)

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of never married adolescents	The proportion of never-married adolescents (aged under 20) in each study arm will be examined.	Baseline, Month 30
Primary	Change in proportion of married adolescents	The proportion of married adolescents (aged under 20) in each study arm will be examined.	Baseline, Month 30
Secondary	Change in decision making	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.	Baseline, Month 30
Secondary	Change in Adolescent Sexual and Reproductive Health and Rights (ASRHR)	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.	Baseline, Month 30
Secondary	Change in social norms	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.	Baseline, Month 30
Secondary	Change in movement building among adolescent girls	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.	Baseline, Month 30
Secondary	Change in gender attitudes among community adults	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.	Baseline, Month 30
Secondary	Change in attitudes on ASRHR among community adults	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.	Baseline, Month 30