Condition category
Musculoskeletal Diseases
Date applied
25/07/2018
Date assigned
02/08/2018
Last edited
31/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Engaging young male slum dwellers in Bangladesh in SRHR (sexual and reproductive health and rights) education is a considerable challenge. Slum-dwellers tend to suffer from a poorer mental and physical health status than the rest of the population, and their knowledge of SRHR issues is typically low. They can be more prone to risky behavior, early marriage, drugs, and violence. Interventions so far mostly targeted women, with men receiving less attention.
We propose a set of interventions to engage young men to explore existing and alternative attitudes towards their own and their peers’ sexual health and relationships. We will engage the study participants in guided dramatic acting to investigate individual problems and clarify issues, facilitate insights, personal growth, and integration on cognitive, affective and behavioural levels. This study will also be used to develop counselling modules and formulate innovative strategies for education on sexuality, gender and SRHR.

Who can participate?
Young men from the Vashantek Slum in Mirpur, Dhaka North City Corporation

What does the study involve?
Participants will be randomised into either the intervention or active control group.
Participants in the intervention group will be asked to take part in 4 6-hour weekly sessions of psychodrama over 5 weeks (there is a 1 week gap between the second and third sessions) in groups of 10. These sessions will involve discussions about gender role norms, masculinity, risky sexual behaviour, mental health and wellbeing, along with domestic violence, gender-based domestic chores and issues around daily life and sexual relationships. They will also be asked to participate in role presentation, role interviews, role reversal and mirroring.
Participants in the control group will be asked to attend a weekly 1 hour session for 4 weeks, involving theatrical games and discussions on stress and coping strategies in their day-to-day lives.
Participants in both groups will be asked to complete questionnaires about gender non-conformity, gender roles, sexual behaviour and general health.

What are the possible benefits and risks of participating?
The possible benefit to participants of taking part are that it will identify the underlying reasons for their risky sexual behaviour, providing knowledge on how to change this behaviour. The risk of participating is that they may have to reveal personal experiences during the sessions and it may require a significant time commitment.
If any participant shows any need for special psychiatric care, we will have a referral protocol to link them up with local mental health care facilities for professional attention.

Where is the study run from?
BRAC James P Grant School of Public Health, BRAC University, Bangladesh

When is the study starting and how long is it expected to run for?
March 2016 to September 2018

Who is funding the study?
Netherlands Organisation for Scientific Research (NWO) (The Netherlands)

Who is the main contact?
Prof. Malabika Sarker
malabika@bracu.ac.bd

Trial website

Contact information

Type

Scientific

Primary contact

Prof Malabika Sarker

ORCID ID

http://orcid.org/0000-0001-7293-8805

Contact details

BRAC James P Grant School of Public Health
BRAC University
5th Floor
(Level-6)
icddr,b Building
68 Shahid Tajuddin Ahmed Sharani
Mohakhali
Dhaka
1212
Bangladesh

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

88

Study information

Scientific title

Culturally contextualized psychodrama to change the perception of young men in the slums of Dhaka city regarding gender equitable norms: An experimental approach

Acronym

Study hypothesis

Psychodramatic interventions can have a positive change in perception of traditional masculine norms associated with risky sexual behaviors among urban young men aged 18 to 29 years.

Ethics approval

BRAC James P Grant School of Public Health, BRAC University Ethical Review Committee, 06/10/2016, reference/protocol no: 88

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mental health, masculine non-conformity, sexual health and behaviour

Intervention

80 young men aged 18-29 from the Vashantek slum in Dhaka were randomised into a 1:1 ratio into intervention and active control groups.
Participants in the intervention group participated in 4 weekly 6 hour offsite psychodrama sessions, with a 1 week gap between the second and third sessions. The participants in psychodrama are expected to examine their thoughts, attitude, and experiences with gender role norms, masculinity, risky sexual behavior, mental health, and psychological well-being. Gender-based role norms will also include discussion on domestic and intimate partner violence, gender-based domestic chores as well as issues around daily life and sexual relationship. In addition, role presentation, role interview, role reversal, mirroring, doubling techniques of psychodrama will be part of the sessions.
Participants in the active control group attended a weekly 1 hour session in the community for 4 weeks, where they took part in different theatrical games, sociometric activities and discussions on stress and coping strategies in their day-to-day lives.
The overall trial period was 4 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The following were assessed at the baseline and at the end of the intervention (4 months):
1. Attitude towards gender norms assessed using Gender Equitable Men (GEM) scale.
2. Men’s personal gender-role attitudes, behaviors, and conflicts assessed using Gender Role Conflict/Stress (GRC/S) scale.

Secondary outcome measures

The following were assessed at the end of the intervention (4 months):
1. Self-reported risky sexual behavior.
2. Psychological wellbeing assessed using the General Health Questionnaire (GHQ) scale.

Overall trial start date

03/03/2016

Overall trial end date

30/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Current resident of Vashantek slum in Mirpur North City Corporation, Dhaka, Bangladesh
2. Male
3. Aged 19-29
4. Above median GRC/S and GEM scores
5. Agree to take part in proposed intervention
6. Able to take part for entire 4 month trial period

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

80

Participant exclusion criteria

1. Exhibit any symptoms of unspecified mental health issues. We maintain a referral protocol for such individuals.
2. Fail to provide an informed consent to the interventions and subsequent data collections.

Recruitment start date

02/07/2017

Recruitment end date

31/08/2017

Locations

Countries of recruitment

Bangladesh

Trial participating centre

BRAC James P Grant School of Public Health, BRAC University
5th Floor, (Level-6), icddr,b Building, 68 Shahid Tajuddin Ahmed Sharani, Mohakhali
Dhaka
1212
Bangladesh

Sponsor information

Organisation

BRAC James P Grant School of Public Health, BRAC University

Sponsor details

5th Floor
(Level-6)
icddr,b Building
68 Shahid Tajuddin Ahmed Sharani
Mohakhali
Dhaka
1212
Bangladesh

Sponsor type

University/education

Website

http://sph.bracu.ac.bd/

Funders

Funder type

Not defined

Funder name

Netherlands Organisation for Scientific Research (NWO)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish the results from analyses to understand the impacts of the interventions in an international peer-reviewed journal. We will also organize workshops to share our findings with relevant stakeholders and policy makers.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes