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Clinical Trials/CTRI/2025/03/082016
CTRI/2025/03/082016
Not yet recruiting
Phase 1/2

Gender Transformative Intervention for Male Partners of Tribal Women in the Perinatal Period

UGC2 sites in 1 country38 target enrollmentStarted: April 1, 2025Last updated:

Overview

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
UGC
Enrollment
38
Locations
2
Primary Endpoint
For Perinatal Tribal Women:

Overview

Brief Summary

Introduction

This study focuses on improving the well-being, quality of life, and mental health of perinatal tribal women residing in the Attapady Tribal Settlement, Kerala. Perinatal mental health is a crucial public health issue, as this period involves significant physiological, psychological, and social transitions. The study aims to assess the effectiveness of a culturally adapted brief gender-transformative intervention among male partners of tribal perinatal women to enhance their engagement in perinatal care and improve maternal well-being.

Methodology

Study Setting: The research is conducted in the Attapady Tribal Settlement in Kerala, which includes the Irula, Kurumba, and Muduga tribal groups.

Research Design: A quasi-experimental study with a pre-post assessment without a control group.

Study Population: Couples within the tribal community, where women are in their perinatal period (pregnancy up to three months postpartum).

Sample Size: 38 couples (including a 10% non-response rate).

Sampling Method: Convenience sampling.

Phases of the Study

1.    Formative Phase (Intervention Co- adaption phase)

Conducting Key Informant Interviews (KIIs) with healthcare professionals.

Focus Group Discussions (FGDs) with community members, including tribal leaders, ASHA workers, and NGOs.

Pilot testing of research tools.

2.    Intervention Phase:

Pre-assessment using standardized scales.

4-session gender-transformative intervention with husbands, including:

Session 1: Mental health & well-being(for Couples)

Session 2: Positive masculinity & partner support(Husband only)

Session 3: Family dynamics & conflict resolution(Husband only)

Session 4: Fatherhood involvement(Husband only)

3.    Post-Intervention Phase:

Assessing changes in key variables three months postpartum.

Data analysis and report writing.

Tools for Data Collection

Generalized Anxiety Disorder Scale (GAD-7)

Patient Health Questionnaire (PHQ-9)

WHO-QOL BREF (Quality of Life Assessment)

WHO-5 Well-being Index

Dyadic Adjustment Scale (DAS)

Malayalam Domestic Violence Scale

Multidimensional Perceived Social Support Scale (MPSS)

Semi-structured questionnaires for demographic and clinical details

Intervention Manual (Co- adaptation from previous manuals)

The intervention is based on previous gender-transformative intervention models like:

Bandebereho Intervention (Rwanda)

Mbereko+Men Programme (Zimbabwe)

UNESCO Gender Transformative Interventions (Bastar, India)

These interventions focus on male involvement, family engagement, and promoting gender equity in maternal health.

Ethical Considerations

Ethical approval from the Institutional Ethics Committee (NIMHANS).

Permission from the State Tribal Development Department, Kerala and Forest department Keral

Informed consent from participants.

Confidentiality and anonymity ensured.

Referral mechanisms for participants experiencing mental distress or domestic violence.

Conclusion

This study aims to evaluate and enhance the role of husbands in perinatal care using a gender-transformative approach. By engaging men in maternal well-being, family support, and gender equity, the intervention is expected to improve perinatal mental health, quality of life, and social dynamics within tribal communities. The findings will contribute to policy recommendations for better maternal and child health programs in tribal settlements.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Perinatal Tribal (Pregnancy period) women and their husbands.
  • The perinatal period has been defined in this study as those with less than 28 weeks (7 months) of pregnancy.
  • Aged more than 18 years
  • Understand and speak the local language, that is, Malayalam or Tamil.

Exclusion Criteria

  • Those who have clinical evidence of intellectual disability (inability to speak or comprehend)
  • Individuals who obtained a high score on the GHQ and PHQ.

Outcomes

Primary Outcomes

For Perinatal Tribal Women:

Time Frame: The intervention plan includes 3 sessions with the husbands and one joint session with couples. | Each session is allocated 45 minutes to 1 hours, ensuring a focused and engaging | experience for participants. The sessions will be meticulously preplanned and conducted | systematically, adhering to a carefully designed structure. To allow for an effective learning | and implementation process, the sessions will be conducted over five months, with a break of | days 10 to 15 interspersed between them. | Post assessments for the intervention will be conducted | approximately three months postpartum (after delivery), allowing participants a reasonable | timeframe that aligns with their convenience.

1. Improved Quality of Life

Time Frame: The intervention plan includes 3 sessions with the husbands and one joint session with couples. | Each session is allocated 45 minutes to 1 hours, ensuring a focused and engaging | experience for participants. The sessions will be meticulously preplanned and conducted | systematically, adhering to a carefully designed structure. To allow for an effective learning | and implementation process, the sessions will be conducted over five months, with a break of | days 10 to 15 interspersed between them. | Post assessments for the intervention will be conducted | approximately three months postpartum (after delivery), allowing participants a reasonable | timeframe that aligns with their convenience.

2. Enhanced Mental Health

Time Frame: The intervention plan includes 3 sessions with the husbands and one joint session with couples. | Each session is allocated 45 minutes to 1 hours, ensuring a focused and engaging | experience for participants. The sessions will be meticulously preplanned and conducted | systematically, adhering to a carefully designed structure. To allow for an effective learning | and implementation process, the sessions will be conducted over five months, with a break of | days 10 to 15 interspersed between them. | Post assessments for the intervention will be conducted | approximately three months postpartum (after delivery), allowing participants a reasonable | timeframe that aligns with their convenience.

3. Better Well-being

Time Frame: The intervention plan includes 3 sessions with the husbands and one joint session with couples. | Each session is allocated 45 minutes to 1 hours, ensuring a focused and engaging | experience for participants. The sessions will be meticulously preplanned and conducted | systematically, adhering to a carefully designed structure. To allow for an effective learning | and implementation process, the sessions will be conducted over five months, with a break of | days 10 to 15 interspersed between them. | Post assessments for the intervention will be conducted | approximately three months postpartum (after delivery), allowing participants a reasonable | timeframe that aligns with their convenience.

4. Increased Utilization of Perinatal Services Increased Decision.

Time Frame: The intervention plan includes 3 sessions with the husbands and one joint session with couples. | Each session is allocated 45 minutes to 1 hours, ensuring a focused and engaging | experience for participants. The sessions will be meticulously preplanned and conducted | systematically, adhering to a carefully designed structure. To allow for an effective learning | and implementation process, the sessions will be conducted over five months, with a break of | days 10 to 15 interspersed between them. | Post assessments for the intervention will be conducted | approximately three months postpartum (after delivery), allowing participants a reasonable | timeframe that aligns with their convenience.

Secondary Outcomes

  • For Husbands:(1. Positive Attitude Change Toward Perinatal Care)

Investigators

Sponsor
UGC
Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Manukrishnan

National institute of Mental Health and Neurosciences

Study Sites (2)

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