Development and Testing of Balika Bodhu
1 other identifier
interventional
2,918
1 country
1
Brief Summary
The study aims to generate knowledge on barriers experienced by married adolescent girls (MAGs) in demanding, accessing and practicing their rights regarding their sexual and reproductive health (SRH), including family planning (FP) use, conception, and seeking health care relating to SRH. We will also explore the underlying factors influencing such barriers. The study will develop and test a social norms intervention that addresses the gaps in programming and in the literature combining a comprehensive empowerment programme for MAGs with engagement of other stakeholders to increase demand, access and practices of positive behaviours in relation to sexual and reproductive health and rights (SRHR) among these girls. We will collaborate with a local organization, who usually work on empowerment and SRHR of women, for implementing the intervention and will build their capacity as well. The study will employ a mixed-method two-arm cluster randomized controlled trial design. All the information generated will inform the program and policy about the barriers and potential solutions to improve demand, access and practices of SRHR among the MAGs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2023
CompletedStudy Start
First participant enrolled
November 8, 2023
CompletedFirst Posted
Study publicly available on registry
November 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedNovember 18, 2023
November 1, 2023
1.3 years
October 12, 2023
November 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Instrumental agency of MAGs in decision making regarding SRHR
The MAGs will be asked about who was the main decision maker regarding: (a) FP use; (b) timing of first conception; and (c) number of children to have. The response options included "1=the MAG herself", "2=husband", "3=jointly" and "4=someone else". A follow up question, "what kind of joint decision it was", was asked in every case when the respose was "jointly". The response options included "1=he said about his choice and I agreed", "he said his choice and forced me to agree", and "3=I said my choice and he agreed". A MAG will be considered having the agency in decision making regarding a specific theme of SRHR and will be coded as "Yes=1" if she decided herself or it was a joint decision without any force on her, and "No=2" otherwise. We will generate a summative score, with higher score indicating higher agency. The score will then be divided into tertiles.
15 months
Secondary Outcomes (21)
Intrinsic agency of MAGs
15 months
Instrumental agency of MAGs
15 months
Collective agency of MAGs
15 months
Critical Consciousness of MAGs related to their consent and choice in SRH
15 months
Knowledge of MAGs regarding SRHR
15 months
- +16 more secondary outcomes
Study Arms (2)
The social norm intervention
EXPERIMENTALThe married adolescent girls (MAGs) and their spouses, and community members from the intervention clusters will receive the social norm intervention.
Pure Control
NO INTERVENTIONParticipants, including married adolescent girls (MAGs), their spouses, and community members from the control clusters, will not receive any intervention.
Interventions
The intervention will target Married adolescent girls, their spouses, and elderly/influential community members. Thirty-six 2-hour weekly sessions will be conducted with MAGs. The session topics will be categorized into two broad headings: i) Health and life skills sessions covering, for example topics such as sex and gender, rights, marriages, SRHR, and ii) Business and entrepreneurship sessions. Spouses of the MAGs will receive 20 2-hour bi-weekly sessions. A total of three 2-hour couples sessions will be held. Elderly women and influential community members will have three 2-hour bi-monthly sessions. In addition, MAGs with leadership qualities will be identified and trained to conduct campaigns and activism. They will also receive training on income generating.
Eligibility Criteria
You may qualify if:
- For MAGs:
- i) Adolescent girls aged 15-19 years; ii) Currently married and living with husband; and iii) Both the girl and her husband have no intention of migrating out within the next 15 months.
- For husbands:
- i) The husbands of the selected adolescent girls will also be eligible to be included in the study.
- For community members:
- i) Aged 35-59 years.
You may not qualify if:
- i) MAGs who are physically or mentally unstable; ii) Any couple having plans to migrate out during the next one and a half years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212, Bangladesh
Related Publications (1)
Mamun MA, Mahmud S, Antu JF, Talukder A, Naved RT. A protocol for a cluster randomized controlled trial to assess the impact of Balika Bodhu: A combined empowerment and social norm based sexual and reproductive health and rights intervention for married adolescent girls in rural Bangladesh. PLoS One. 2024 Aug 23;19(8):e0304988. doi: 10.1371/journal.pone.0304988. eCollection 2024.
PMID: 39178272DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruchira Tabassum naved, PhD
Emeritus Scientist
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2023
First Posted
November 13, 2023
Study Start
November 8, 2023
Primary Completion
February 28, 2025
Study Completion
March 31, 2025
Last Updated
November 18, 2023
Record last verified: 2023-11