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CTRI Number  CTRI/2025/03/082016 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Engaging Male Partners to Support Tribal Mothers During Pregnancy and Childbirth 
Scientific Title of Study   Gender Transformative Intervention for Male Partners of Tribal Women in the Perinatal Period 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manukrishnan 
Designation  Ph.D. Scholar  
Affiliation  National institute of Mental Health and Neurosciences 
Address  Ph.D Scholar, Department of Psychiatric Social Work, NIMHANS, Bangalore,

Bangalore
KARNATAKA
560029
India 
Phone  7907355808  
Fax    
Email  manusopanam0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Manukrishnan 
Designation  Ph.D. Scholar  
Affiliation  National institute of Mental Health and Neurosciences 
Address  Ph.D Scholar, Department of Psychiatric Social Work, NIMHANS, Bangalore,

Bangalore
KARNATAKA
560029
India 
Phone  7907355808  
Fax    
Email  manusopanam0@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manukrishnan 
Designation  Ph.D. Scholar  
Affiliation  National institute of Mental Health and Neurosciences 
Address  Ph.D Scholar, Department of Psychiatric Social Work, NIMHANS, Bangalore,

Bangalore
KARNATAKA
560029
India 
Phone  7907355808  
Fax    
Email  manusopanam0@gmail.com  
 
Source of Monetary or Material Support  
UGC - JRF University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi, India Pin 110002  
 
Primary Sponsor  
Name  UGC  
Address  University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi - 110002. 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anagha N C   Attapady Traibal Settlment   Swami Vivekananda Medical Mission Hospital Agali Attapady Palakkad pin 671124
Palakkad
KERALA 		 8921380913

anaghanarayanan2@gmail.com  
Dr Kimneihat Vaiphei   National institute of Mental Health and Neurosciences  National Institute of Mental Health and Neuro Sciences (NIMHANS) Hosur Road / Marigowda Road, (Lakkasandra, Wilson Garden) Bangalore – 560029
Bangalore
KARNATAKA 		 09845110128

vaiphei1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant tribal women and their Husbands  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gender Transformative Intervention for Male Partners of Tribal Women in the Perinatal Period  Intervention Manual (Co- adaptation from previous manuals) The intervention is based on previous gender-transformative intervention models such as: • Bandebereho Intervention (Rwanda) • Mbereko+Men Programme (Zimbabwe) • UNESCO Gender Transformative Interventions (Bastar, India Themes and sessions 1. Session 1: Mental health & well-being (for Couples) 2. Session 2: Positive masculinity & partner support (Husband only) 3. Session 3: Family dynamics & conflict resolution (Husband only) 4. Session 4: Fatherhood involvement (Husband only) Application The intervention plan includes 3 sessions with the husbands and one joint session with couples. The sessions are primely focuses on providing essential information related to perinatal care, health education, maternal well-being, crisis intervention, and preparations for child rearing and infant care. Conversely, the sessions take a more interactive and activity-based approach. Games and activities will be planned and designed to enhance the partners involvement in perinatal care, foster shared activities, create family-based care plans, and emphasize the fathers role in the transition to child-rearing. 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. The timing and location of each session will be determined based on the convenience and preferences of the participants, promoting accessibility and active participation. Post assessments for the intervention will be conducted approximately three months postpartum (after delivery), allowing participants a reasonable timeframe that aligns with their convenience. The post-assessment will be conducted to evaluate the effectiveness of the intervention with the male partners of perinatal tribal women. The assessment will focus on determining the changes or improvements in perinatal womens mental health, Quality of Life (QoL), experiences of domestic violence, male partner involvement in household chores, and dyadic adjustment with their husband  
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. 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.
2. Aged more than 18 years
3. Understand and speak the local language, that is, Malayalam or Tamil 
 
ExclusionCriteria 
Details  1. Those who have clinical evidence of intellectual disability (inability to speak or
comprehend)
2. Individuals who obtained a high score on the GHQ and PHQ 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
For Perinatal Tribal Women:
1. Improved Quality of Life
2. Enhanced Mental Health
3. Better Well-being
4. Increased Utilization of Perinatal Services Increased Decision.
 		 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 Outcome  
Outcome  TimePoints 
For Husbands:
1. Positive Attitude Change Toward Perinatal Care
2. Increased Participation in Perinatal Care – Greater involvement in household chores, childcare, and emotional support.
3. Shift in Gender Norms and Reduced Gender Bias – More equitable gender role perceptions in caregiving responsibilities.
 		 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.  
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [manusopanam0@gmail.com].

  6. For how long will this data be available start date provided 31-12-2025 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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.

 

 


 
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