NCT06916377

Brief Summary

This project aims to test the scalability and cost-effectiveness of edutainment-soap operas designed to challenge harmful social norms and promote resilience-as a strategy to improve mental health and reduce intimate partner violence (IPV) in rural Bangladesh. Investigators will run a clustered randomized control trial in which villages will be randomized to one of three versions of the same soap opera: (i) Norms: Challenges harmful norms that condone IPV, targeting the belief that violence is an acceptable way to assert control or maintain reputation, (ii) Norms + Skills: builds on the norms campaign by adding CBT-based skills for stress management and non-violent conflict resolution, (iii) Placebo: No violence content. Investigators will evaluate the impact on attitudes towards IPV and IPV incidence.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

September 19, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

March 31, 2025

Last Update Submit

March 31, 2025

Conditions

Outcome Measures

Primary Outcomes (11)

  • Demographic and Health Survey (DHS) to assess Acceptability of IPV

    Standardized attitudinal questions from the Demographic and Health Survey (DHS), which capture whether violence is considered justified in specific situations to measure changes in husbands' personal attitudes towards IPV. Measured by the average score on a justification index across treatments. This index is a normalized index of how justified men think it is for a husband to use IPV.

    1 month post intervention

  • Hypothetical vignettes to assess Acceptability of IPV

    Hypothetical vignettes, where respondents evaluate the likely and socially acceptable behavior of a hypothetical husband whose wife transgressed a gender norm. These vignettes mitigate social desirability bias and improve the accuracy of responses on sensitive topics to measure changes in husbands' personal attitudes towards IPV. Measured by the average level of violence respondents across treatments believe hypothetical husband will and should assign if the hypothetical wife transgresses. The scale will be between 0 and 5.

    1 month post intervention

  • Hypothetical vignettes to assess Perceptions about others' acceptability of IPV.

    Husbands' perceptions about others' attitudes towards IPV were measured using the hypothetical vignettes. Respondents estimate the attitudes of the other surveyed men in their community using visual aids and stickers, each representing a different respondent. Hypothetical vignettes, where respondents evaluate the likely and socially acceptable behavior of a hypothetical husband whose wife transgressed a gender norm. These vignettes mitigate social desirability bias and improve the accuracy of responses on sensitive topics to measure changes in husbands' personal attitudes towards IPV. This will be measured by the average level of violence respondents across treatments believe other men in their community will assign if the hypothetical wife transgresses. The scale will be between 0 and 5.

    1 month post intervention

  • Use of coping strategies to assess Men's resilience and mental health.

    Men's coping and emotional self-regulation strategies are measured using an index constructed from responses provided by their wives. This index includes selected questions on men's approaches to conflict management from the Revised Conflict Tactics Scale, adapted items from the Bengali version of the Brief Resilient Coping Scale that capture spouses' perceptions of men's behavior, and measures of substance use. IPV-related questions are intentionally excluded, as these behaviors represent a distinct conceptual category measured separately. To simplify interpretation, the index is standardized relative to the control group by subtracting the control group's mean and dividing by its standard deviation. Consequently, the resulting index has a mean of zero and a standard deviation of one within the control group. Higher values of the index indicate more positive coping styles and better emotional regulation.

    1 month post intervention

  • Patient Health Questionnaire-9 (PHQ-9) to assess Men's resilience and mental health.

    Husbands' self-reported symptoms of depression measured using the PHQ-9 scale. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.

    1 month post intervention

  • Stressors and experiences to assess Men's resilience and mental health.

    Husbands' open-ended responses on daily stressors and positive experiences to measure husbands' resilience and emotional well-being. A summary index with two subcomponents is developed. First, a sub-index of daily events using an adapted version of the Daily Hassles and Uplifts Scale that includes items relevant to our target population. Second, a sub-index that aggregates men's appraisal of stressors and is based on the 10-item version of the Perceived Stress Scale validated in Bangladesh. Each subcomponent is standardized to have a mean of zero and a standard deviation of one for the control group. The summary index is defined as the equally weighted average of these standardized sub-indexes, with signs oriented so that higher values consistently indicate more favorable outcomes (fewer stressors and/or lower perceived stress).

    1 month post intervention

  • Biometric stress indicators to assess Men's resilience and mental health.

    Biometric stress indicators, captured by Empatica E4 wristbands during sensitive survey modules, measuring physiological markers of emotional regulation and stress to measure husbands' resilience and emotional well-being. Specifically, electrodermal activity (EDA) data, expressed in microsiemens (μS), is used to analyze Skin Conductance Responses (SCRs). SCRs are quantified using a trough-to-peak (TTP) analysis, where the amplitude of each response is measured as the difference between the peak and the preceding trough within a defined time window. To identify event-related SCRs, a response window of 1 to 5 seconds following a stimulus is applied, with a minimum amplitude threshold of 0.01 μS to detect significant responses. The primary outcome variable is the sum of SCR amplitudes for significant responses. The average sum of SCR amplitudes across treatment groups is compared to assess differences in physiological stress responses.

    1 month post intervention

  • Adapted version of the DHS to assess Prevalence and frequency of IPV.

    An adapted version of the DHS, covering physical, psychological, financial, and sexual violence. To enhance privacy and reduce misreporting, women use visual response tools to answer these questions privately to measure women's experiences of IPV. Measured by the average of a standardized IPV index. This is a normalized index which captures the frequency (never, very few times, sometimes, or very often) of women's reported experiences of IPV in the past six months. Higher values indicate higher frequency of IPV.

    1 month post intervention

  • Number of participants with IPV-related injuries to assess Prevalence and frequency of IPV.

    Enumerators' reports of visible IPV-related injuries, such as bruises, documented using a standardized reporting protocol. Enumerators receive specialized training to identify and record signs of physical violence, with a focus on facial bruises and scratches, which remain visible even for veiled women to measure women's experiences of IPV.

    1 month post intervention

  • Health assessments to assess Prevalence and frequency of IPV.

    Health assessments by community health workers, who check for IPV-related injuries to measure women's experiences of IPV. Measured by the percentage of female respondents across treatments on whom community health workers identify IPV-related injuries.

    1 month post intervention

  • Incidence of IPV to assess Prevalence and frequency of IPV.

    Women's self-reports of IPV through rolling phone surveys six to twelve months post-intervention. Measured by the average of a standardized IPV index. This is a normalized index which captures the frequency (never, very few times, sometimes, or very often) of women's reported experiences of IPV in the past six months.

    Baseline and 6-12 months post intervention

Secondary Outcomes (5)

  • Respectable man scale to assess Men's self-esteem.

    1 month post intervention

  • Perceived respectabillity to assess Men's reputation

    1 month post intervention

  • Cost-effectiveness of the edutainment campaigns assessed by Reduction to IPV exposure

    1 month post intervention

  • Cost-effectiveness of the edutainment campaigns assessed by benefit-to-cost ratio

    1 month post intervention

  • Cost-effectiveness of the edutainment campaigns assessed by benefit-to-cost ratio

    1 month post intervention

Study Arms (12)

Norms with Private Delivery

EXPERIMENTAL

Soap opera that challenges harmful norms that condone IPV, targeting the belief that violence is an acceptable way to assert control or maintain reputation Private Delivery Mode: Men watch the soap opera privately at home on handheld devices.

Behavioral: Edutainment Content: Norms Campaign

Norms + Skills with Private Delivery

EXPERIMENTAL

Soap opera that builds on the norms campaign by adding CBT-based skills for stress management and non-violent conflict resolution Private Delivery Mode: Men watch the soap opera privately at home on handheld devices.

Behavioral: Edutainment Content: Norms CampaignBehavioral: Cognitive Behavioral Therapy (CBT)-based skills

Placebo with Private Delivery

EXPERIMENTAL

Soap opera that features unrelated content to serve as a control group, isolating the effects of norms and resiliency messaging. Private Delivery Mode: Men watch the soap opera privately at home on handheld devices.

Behavioral: Edutainment Content: Placebo Campaign

Norms with Public Delivery

EXPERIMENTAL

Soap opera that challenges harmful norms that condone IPV, targeting the belief that violence is an acceptable way to assert control or maintain reputation Public Delivery Mode: Men watch the soap opera publicly through community screenings.

Behavioral: Edutainment Content: Norms Campaign

Norms + Skills with Public Delivery

EXPERIMENTAL

Soap opera that builds on the norms campaign by adding CBT-based skills for stress management and non-violent conflict resolution Public Delivery Mode: Men watch the soap opera publicly through community screenings.

Behavioral: Edutainment Content: Norms CampaignBehavioral: Cognitive Behavioral Therapy (CBT)-based skills

Placebo with Public Delivery

EXPERIMENTAL

Soap opera that features unrelated content to serve as a control group, isolating the effects of norms and resiliency messaging. Public Delivery Mode: Men watch the soap opera publicly through community screenings.

Behavioral: Edutainment Content: Placebo Campaign

Norms with Private Delivery and Cash-for-Work program

EXPERIMENTAL

Soap opera that challenges harmful norms that condone IPV, targeting the belief that violence is an acceptable way to assert control or maintain reputation Private Delivery Mode: Men watch the soap opera privately at home on handheld devices. Cash-for-Work: Small weekly payments for viewing and providing feedback on the media content.

Behavioral: Edutainment Content: Norms Campaign

Norms + Skills with Private Delivery and Cash-for-Work program

EXPERIMENTAL

Soap opera that builds on the norms campaign by adding CBT-based skills for stress management and non-violent conflict resolution Private Delivery Mode: Men watch the soap opera privately at home on handheld devices. Cash-for-Work: Small weekly payments for viewing and providing feedback on the media content.

Behavioral: Edutainment Content: Norms CampaignBehavioral: Cognitive Behavioral Therapy (CBT)-based skills

Placebo with Private Delivery and Cash-for-Work program

EXPERIMENTAL

Soap opera that features unrelated content to serve as a control group, isolating the effects of norms and resiliency messaging. Private Delivery Mode: Men watch the soap opera privately at home on handheld devices. Cash-for-Work: Small weekly payments for viewing and providing feedback on the media content.

Behavioral: Edutainment Content: Placebo Campaign

Norms with Public Delivery and Cash-for-Work program

EXPERIMENTAL

Soap opera that challenges harmful norms that condone IPV, targeting the belief that violence is an acceptable way to assert control or maintain reputation Public Delivery Mode: Men watch the soap opera publicly through community screenings. Cash-for-Work: Small weekly payments for viewing and providing feedback on the media content.

Behavioral: Edutainment Content: Norms Campaign

Norms + Skills with Public Delivery and Cash-for-Work program

EXPERIMENTAL

Soap opera that builds on the norms campaign by adding CBT-based skills for stress management and non-violent conflict resolution Public Delivery Mode: Men watch the soap opera publicly through community screenings. Cash-for-Work: Small weekly payments for viewing and providing feedback on the media content.

Behavioral: Edutainment Content: Norms CampaignBehavioral: Cognitive Behavioral Therapy (CBT)-based skills

Placebo with Public Delivery and Cash-for-Work program

EXPERIMENTAL

Soap opera that features unrelated content to serve as a control group, isolating the effects of norms and resiliency messaging. Public Delivery Mode: Men watch the soap opera publicly through community screenings. Cash-for-Work: Small weekly payments for viewing and providing feedback on the media content.

Behavioral: Edutainment Content: Placebo Campaign

Interventions

Soap opera that challenges harmful norms that condone IPV, targeting the belief that violence is an acceptable way to assert control or maintain reputation.

Norms + Skills with Private DeliveryNorms + Skills with Private Delivery and Cash-for-Work programNorms + Skills with Public DeliveryNorms + Skills with Public Delivery and Cash-for-Work programNorms with Private DeliveryNorms with Private Delivery and Cash-for-Work programNorms with Public DeliveryNorms with Public Delivery and Cash-for-Work program

CBT-based skills for stress management and non-violent conflict resolution.

Norms + Skills with Private DeliveryNorms + Skills with Private Delivery and Cash-for-Work programNorms + Skills with Public DeliveryNorms + Skills with Public Delivery and Cash-for-Work program

Soap opera that features unrelated non-violent content

Placebo with Private DeliveryPlacebo with Private Delivery and Cash-for-Work programPlacebo with Public DeliveryPlacebo with Public Delivery and Cash-for-Work program

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsHusband (male) and wife (female) from each household
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • married men and women over the legal age of majority in Bangladesh

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BRAC University

Dhaka, Bangladesh

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nina Buchmann, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Treatment assignment was stratified at the union level, the smallest administrative rural unit. From the two districts combined, a total of 88 unions were selected using Probability Proportional to Size (PPS). Each union contained 5 clusters (villages), yielding a total of 440 clusters. In each village, investigators randomly sampled 20 married couples aged 18-65, yielding a total of 8,800 married couples.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 8, 2025

Study Start

September 19, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 8, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations