NCT04015856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,828

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2022

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

2.7 years

First QC Date

July 9, 2019

Last Update Submit

February 16, 2022

Conditions

Child Marriage

Keywords

Social research

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Change in decision making

    Baseline, Month 30

  • Change in Adolescent Sexual and Reproductive Health and Rights (ASRHR)

    Baseline, Month 30

  • Change in social norms

    Baseline, Month 30

  • Change in movement building among adolescent girls

    Baseline, Month 30

  • Change in gender attitudes among community adults

    Baseline, Month 30

  • +1 more secondary outcomes

Study Arms (3)

Full TP intervention including emphasized social norms change

EXPERIMENTAL

Participants in this study arm will receive the full TP intervention, including emphasized social norms change, for 18 months.

Behavioral: Full TP intervention

Light TP intervention without emphasized social norms change

ACTIVE COMPARATOR

Participants in this study arm will receive the light TP intervention, without emphasized social norms change, for 18 months

Behavioral: Light TP intervention

Control

NO INTERVENTION

The control group will not have any study interventions.

Interventions

Full TP interventionBEHAVIORAL

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.

Full TP intervention including emphasized social norms change
Light TP interventionBEHAVIORAL

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.

Light TP intervention without emphasized social norms change

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • marginalized communities based on CARE Nepal formula
  • communities prioritized by Nepal Government
  • no concurrent non-governmental organization (NGO) programming
  • no concurrent CARE programming
  • unmarried
  • age 12 -under 17
  • living in study community
  • no plans to migrate in subsequent 24 months
  • male and female parental figures of an adolescent who has been recruited to participate in the intervention and associated measurement

You may not qualify if:

  • none
  • at least 25 years of age
  • living in one of the study Communities
  • no plans to migrate during the next two years
  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interdisciplinary Analysts

Kathmandu, 44600, Nepal

Location

Related Publications (3)

  • Clark CJ, Jashinsky K, Renz E, Bergenfeld I, Durr RL, Cheong YF, Kalra S, Laterra A, Yount KM. Qualitative endline results of the tipping point project to prevent child, early and forced marriage in Nepal. Glob Public Health. 2023 Jan;18(1):2287606. doi: 10.1080/17441692.2023.2287606. Epub 2023 Dec 6.

    PMID: 38054604DERIVED

  • Yount KM, Durr RL, Bergenfeld I, Sharma S, Clark CJ, Laterra A, Kalra S, Sprinkel A, Cheong YF. Impact of the CARE Tipping Point Program in Nepal on adolescent girls' agency and risk of child, early, or forced marriage: Results from a cluster-randomized controlled trial. SSM Popul Health. 2023 Apr 17;22:101407. doi: 10.1016/j.ssmph.2023.101407. eCollection 2023 Jun.

    PMID: 37251506DERIVED

  • 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.

    PMID: 34312191DERIVED

Study Officials

  • Kathryn Yount, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 11, 2019

Study Start

May 2, 2019

Primary Completion

January 4, 2022

Study Completion

January 4, 2022

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Full baseline and endline datasets will be made available for sharing.

Shared Documents
STUDY PROTOCOL, 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

Locations

NE(1)