Preventing Early Child Marriage in Nepal

• ClinicalTrials.gov Identifier: NCT04015856
• Recruitment Status: Completed
• First Posted: July 11, 2019
• Last Update Posted: February 17, 2022
• Sponsor: Emory University
• Collaborator: Cooperative for Assistance and Relief Everywhere, Inc. (CARE)
• Information provided by (Responsible Party): Kathryn Yount, Emory University

Tracking Information

• First Submitted Date: July 9, 2019
• First Posted Date: July 11, 2019
• Last Update Posted Date: February 17, 2022
• Actual Study Start Date: May 2, 2019
• Actual Primary Completion Date: January 4, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 9, 2019)

• Change in proportion of never married adolescents [ Time Frame: Baseline, Month 30 ]
  The proportion of never-married adolescents (aged under 20) in each study arm will be examined.
• Change in proportion of married adolescents [ Time Frame: Baseline, Month 30 ]
  The proportion of married adolescents (aged under 20) in each study arm will be examined.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 30, 2020)

• Change in decision making [ Time Frame: Baseline, Month 30 ]
  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.
• Change in Adolescent Sexual and Reproductive Health and Rights (ASRHR) [ Time Frame: Baseline, Month 30 ]
  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.
• Change in social norms [ Time Frame: Baseline, Month 30 ]
  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.
• Change in movement building among adolescent girls [ Time Frame: Baseline, Month 30 ]
  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.
• Change in gender attitudes among community adults [ Time Frame: Baseline, Month 30 ]
  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.
• Change in attitudes on ASRHR among community adults [ Time Frame: Baseline, Month 30 ]
  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.

Original Secondary Outcome Measures (submitted: July 9, 2019)

• Change in decision making [ Time Frame: Baseline, Month 30 ]
  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.
• Change in Adolescent Sexual and Reproductive Health and Rights (ASRHR) [ Time Frame: Baseline, Month 30 ]
  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.
• Change in social norms [ Time Frame: Baseline, Month 30 ]
  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.
• Change in movement building among adolescent girls [ Time Frame: Baseline, Month 30 ]
  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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Preventing Early Child Marriage in Nepal
• Official Title: Impact Evaluation of the Tipping Point Project in Nepal: An Intervention to Prevent Early Child Marriage
• Brief 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.

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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Wards (the lowest government administrative units in Nepal) will be treated as clusters or the primary sampling units in this study. Each cluster will be randomly assigned to one of the three arms. Adolescents residing in the study wards will be recruited.

Masking: None (Open Label)
Primary Purpose: Prevention

• Condition: 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.
• Behavioral: 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.

Study Arms

• 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.
  Intervention: Behavioral: Full TP intervention
• 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
  Intervention: Behavioral: Light TP intervention
• No Intervention: Control
  The control group will not have any study interventions.

• Publications *: Yount KM, Clark CJ, Bergenfeld I, Khan Z, Cheong YF, Kalra S, Sharma S, Ghimire S, Naved RT, Parvin K, Al Mamun M, Talukder A, Laterra A, Sprinkel A; Tipping Point Program Study Team. Impact evaluation of the Care Tipping Point Initiative in Nepal: study protocol for a mixed-methods cluster randomised controlled trial. BMJ Open. 2021 Jul 26;11(7):e042032. doi: 10.1136/bmjopen-2020-042032.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 30, 2020): 2828
• Original Estimated Enrollment (submitted: July 9, 2019): 3094
• Actual Study Completion Date: January 4, 2022
• Actual Primary Completion Date: January 4, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 16 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Nepal

Administrative Information

• NCT Number: NCT04015856
• Other Study ID Numbers: IRB00109419
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Full baseline and endline datasets will be made available for sharing.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Individual participant data will be available for sharing upon acceptance of main results for publication or 24 months after completion of endline, whichever comes first.
• Access Criteria: Individual participant data will be accessible by written permission of the project principal investigators for analyses not related to the primary aims of this study, unless to test reproducibility. Access to the data can be requested by writing to the CARE Tipping Point Program Director anne.sprinkel@care.org

• Responsible Party: Kathryn Yount, Emory University
• Study Sponsor: Emory University
• Collaborators: Cooperative for Assistance and Relief Everywhere, Inc. (CARE)

Investigators

• Principal Investigator: Kathryn Yount, PhD; Emory University

• PRS Account: Emory University
• Verification Date: February 2022