跳至主要内容
临床试验/CTRI/2025/03/082016
CTRI/2025/03/082016尚未招募1/2 期

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

UGC2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
38
试验地点
2
主要终点
For Perinatal Tribal Women:

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

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

结局指标

主要结局

For Perinatal Tribal Women:

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

时间窗: 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.

次要结局

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

研究者

发起方
UGC
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Manukrishnan

National institute of Mental Health and Neurosciences

研究点 (2)

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