Child MarriageNCT04015856
Preventing Early Child Marriage in Nepal
A study testing Full TP intervention and Light TP intervention in people with Child Marriage, run by Emory University at 1 site in Nepal.
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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Child Marriage
- What is being tested?
- Full TP intervention and Light TP intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,828 participants
- Where
- 1 siteNepal
- Study dates
- 2 May 2019to 4 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 16Show fewer
- 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
- at least 25 years of age
- living in one of the study Communities
- no plans to migrate during the next two years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Evaluation of the Tipping Point Project in Nepal: An Intervention to Prevent Early Child Marriage
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.
Read the 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.
- Conditions
- Child Marriage
- Being tested
- Full TP intervention, Light TP intervention
- Keywords
- Social research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full TP interventionBehavioural
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 interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Light TP intervention |
| Control | No intervention | The control group will not have any study interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of never married adolescents
The proportion of never-married adolescents (aged under 20) in each study arm will be examined.
Measured: Baseline, Month 30
Change in proportion of married adolescents
The proportion of married adolescents (aged under 20) in each study arm will be examined.
Measured: Baseline, Month 30
Secondary outcomes (6)
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.
Measured: Baseline, Month 30
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.
Measured: Baseline, Month 30
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.
Measured: Baseline, Month 30
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.
Measured: Baseline, Month 30
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.
Measured: Baseline, Month 30
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.
Measured: Baseline, Month 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start2 May 2019
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child MarriageStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2,828 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative for Assistance and Relief Everywhere, Inc. (CARE)
- Responsible party
- Principal investigator, Kathryn Yount, Emory University
- Investigators
- Kathryn Yount, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015856
- Sponsor's protocol ID
- IRB00109419
- Status last verified
- Feb 2022
- First submitted
- 9 Jul 2019
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Full baseline and endline datasets will be made available for sharing.
Publications
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.
PubMed 38054604Yount 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.
PubMed 37251506Yount 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.
PubMed 34312191
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the Tipping Point Project in Nepal: An Intervention to Prevent Early Child Marriage
- ClinicalTrials.gov ID
- NCT04015856
- Acronym / sponsor ID
- IRB00109419
- Conditions
- Child Marriage
- Keywords
- Social research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,828 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Cooperative for Assistance and Relief Everywhere, Inc. (CARE)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Full TP intervention including emphasized social norms change | Experimental | Behavioral: Full TP interventionParticipants in this study arm will receive the full TP intervention, including emphasized social norms change, for 18 months. |
| Light TP intervention without emphasized social norms change | Active comparator | Behavioral: Light TP interventionParticipants in this study arm will receive the light TP intervention, without emphasized social norms change, for 18 months |
| Control | No intervention | –The control group will not have any study interventions. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full TP interventionCARE'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. | Behavioural | Full TP intervention including emphasized social norms change |
| Light TP interventionThe 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. | Behavioural | Light TP intervention without emphasized social norms change |
Primary outcome
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.
6 secondary outcomes
Change in decision making
Time frame: Baseline, Month 30
Change in Adolescent Sexual and Reproductive Health and Rights (ASRHR)
Time frame: Baseline, Month 30
Change in social norms
Time frame: Baseline, Month 30
Change in movement building among adolescent girls
Time frame: Baseline, Month 30
Change in gender attitudes among community adults
Time frame: Baseline, Month 30
Change in attitudes on ASRHR among community adults
Time frame: Baseline, Month 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Derived from this study: PubMed 38054604Clark 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.
- Derived from this study: PubMed 37251506Yount 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.
- Derived from this study: PubMed 34312191Yount 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.
- Individual participant dataSharing planned: Yes. Full baseline and endline datasets will be made available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Yount, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full TP intervention and Light TP intervention in people with Child Marriage, run by Emory University at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proportion of never married adolescents (time frame: Baseline, Month 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04015856, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.