Clinical trial NCT04015856: Preventing Early Child Marriage in Nepal
Official title: Impact Evaluation of the Tipping Point Project in Nepal: An Intervention to Prevent Early Child Marriage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Marriage
Keywords: Social research
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Cooperative for Assistance and Relief Everywhere, Inc. (CARE)
First posted: 2019-07-11
Enrollment: 2828
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in proportion of never married adolescents
timeFrame: Baseline, Month 30
measure: Change in proportion of married adolescents
timeFrame: Baseline, Month 30
Secondary outcomes:
measure: Change in decision making
timeFrame: Baseline, Month 30
measure: Change in Adolescent Sexual and Reproductive Health and Rights (ASRHR)
timeFrame: Baseline, Month 30
measure: Change in social norms
timeFrame: Baseline, Month 30
measure: Change in movement building among adolescent girls
timeFrame: Baseline, Month 30
measure: Change in gender attitudes among community adults
timeFrame: Baseline, Month 30
measure: Change in attitudes on ASRHR among community adults
timeFrame: Baseline, Month 30
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Interdisciplinary Analysts
Study officials:
affiliation: Emory University
name: Kathryn Yount, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.