NCT03965273

Brief Summary

This study evaluates whether an intervention, namely Tipping Point (TP), can reduce child marriage and increase decision making capability among the adolescent girls in rural areas. This is a cluster randomized controlled trial with three intervention arms - full TP package, light TP package (differs from the full TP only in terms of the intensity of the social norms change component) and control. The study is being conducted in Pirgacha sub district of Rangpur district in Bangladesh. A 18-month intervention will be in place after completion of the baseline survey and the endline survey will be conducted 18 months after the intervention completion. This design will allow the investigators to measure the impact of full TP intervention, light TP intervention and the emphasized social norms change.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,699

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 22, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

February 1, 2022

Enrollment Period

3.5 years

First QC Date

May 23, 2019

Last Update Submit

March 29, 2022

Conditions

Child Marriage

Keywords

Child marriageTipping PointCRCTImpactBangladesh

Outcome Measures

Primary Outcomes (2)

  • Child marriage

    Rate of child marriage will be measured by collecting information on age at marriage for each of the married household members during the enumeration of households. Information will be collected for each of the present members of the households as well as for members that were married of to another family during the last one year.

    36 months

  • Decision making ability of adolescent girls

    Decision making will be measured by asking few questions around decision making regarding education, marriage, mobility, participation in financial activities.

    36 months

Secondary Outcomes (6)

  • Attitudes towards gender and rights

    36 months

  • Aspiration and choices of adolescent of adolescent girls

    36 months

  • Communication and negotiation skill of adolescent girls

    36 months

  • Adolescent Sexual and Reproductive Health and Rights (ASRHR)

    36 months

  • Social norms related to child marriage

    36 months

  • +1 more secondary outcomes

Study Arms (3)

Full TP

EXPERIMENTAL

Full TP intervention including emphasized social norms change

Behavioral: Full TP

Light TP

EXPERIMENTAL

Light TP intervention without emphasized social norms change

Behavioral: Light TP

Pure control

NO INTERVENTION

Pure control

Interventions

Full TPBEHAVIORAL

The overall Tipping Point intervention package will span 18 months and will involve: i) Weekly facilitated training sessions with girls' groups and boys' groups; ii) Dialogue sessions jointly with girls' groups and fathers' groups, and girls' groups and boys' groups; iii) Community and Social Norms Change Component; iv) Facilitated sessions with mothers' groups and (separate) fathers' groups; v) 2-days intensive facilitated workshop with selected religious leaders and influential people; vi) Village savings and loans associations (VSLAs) formed by the girls' group members to create opportunities for girls to engage in age-appropriate income generating activities and build their potential as entrepreneurs; vii) Trainings of girls, boys and parents with special interest in activism.

Full TP
Light TPBEHAVIORAL

The overall Tipping Point intervention package will span 18 months and will involve: i) Weekly facilitated training sessions with girls' groups and boys' groups; ii) Dialogue sessions jointly with girls' groups and fathers' groups, and girls' groups and boys' groups; iii) Facilitated sessions with mothers' groups and (separate) fathers' groups; iv) 2-days intensive facilitated workshop with selected religious leaders and influential people; v) Village savings and loans associations (VSLAs) formed by the girls' group members to create opportunities for girls to engage in age-appropriate income generating activities and build their potential as entrepreneurs; vi) Trainings of girls, boys and parents with special interest in activism.

Light TP

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For girls' and boys'
  • Aged 12-15 years
  • Unmarried
  • Usual resident of the community
  • For Community Members
  • Aged 25 years or more and usual resident of the community
  • For fathers' and mothers'
  • Father (or mother) of adolescent girl or boy group member

You may not qualify if:

  • For girls' and boys'
  • Aged \<12 or \>15 years
  • Married
  • Not a usual resident of the community
  • For Community Members
  • Aged \<25 years or not a usual resident of the community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community

Rangpur City, 5450, Bangladesh

RECRUITING

Related Publications (47)

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  • Naved RT, Mahmud S, Al Mamun M, Parvin K, Kalra S, Laterra A, Sprinkel A. Effectiveness of combined interventions to empower girls and address social norms in reducing child marriage in a rural sub-district of Bangladesh: A Cluster Randomised Controlled Trial of the Tipping Point Initiative. J Glob Health. 2024 Feb 23;14:04020. doi: 10.7189/jogh.14.04020.

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  • Naved RT, Kalra S, Talukder A, Laterra A, Nunna TT, Parvin K, Al Mamun M. An Exploration of Social Norms That Restrict Girls' Sexuality and Facilitate Child Marriage in Bangladesh to Inform Policies and Programs. J Adolesc Health. 2022 Mar;70(3S):S17-S21. doi: 10.1016/j.jadohealth.2021.12.002.

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MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Ruchira Tabassum Naved, Ph.D

    Senior Scientist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M. A. Salam Khan, MBA

CONTACT

(+88-02) 9827084salamk@icddrb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The trial employs a three arm Cluster Randomized Controlled Trial (CRCT) design and uses both quantitative and qualitative methods for evaluating TP. 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 This 3-arm design will enable us to measure the effect of the light TP intervention as well as the effect of social norms change on TP outcomes. The effects will be determined by comparing the three arms as follows: Arm 1 - Arm 3 = Effect of full TP intervention Arm 2 - Arm 3 = Effect of light TP intervention Arm 1 - Arm 2 = Effect of emphasized social norms change TP will be implemented in one upazila (sub-district) of Rangpur district. Rangpur has been selected as the median age at marriage is 15 years among women aged 20-49, which is the lowest in the country.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 29, 2019

Study Start

October 22, 2018

Primary Completion

April 30, 2022

Study Completion

December 31, 2022

Last Updated

March 31, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

De-identified data will be shared according to icddr,b's official policy and as per requirement of the approved protocol.

Time Frame
After three years of the completion of the study
Access Criteria
The data could be shared on request from researchers who will use data absolutely on non-profitable purpose. The request has to be reached to Ms. Armana Ahmed (aahmed@icddrb.org), Head, Research Administration, icddr,b. The icddr,b research administration will then review and decide about sharing de-identified data.

Locations

BA(1)