NCT07108049

Brief Summary

This sub-study is part of a larger randomized controlled trial (RCT) titled Disentangling and Preventing Economic Violence against Women (ECOVI). It is conducted in rural and urban communities across Maharashtra, Andhra Pradesh, and Rajasthan, India. The sub-study evaluates the impact of a couples-based financial literacy and gender-transformative intervention on relationship strength, empathy, and mental health among married couples. Using a two-arm cluster RCT design, 150 clusters (villages or community units) are randomized to intervention or control, with \~15 husband-wife pairs per cluster (approximately 2,250 couples in total). Outcomes are measured at baseline (pre-intervention) and endline (post-intervention) approximately six months after delivery of the intervention to assess changes in perceived relationship strength, empathy (using an adapted relationship strengths and empathy scale), and mental health (General Health Questionnaire-6, GHQ-6). The study will also explore whether improvements in relationship strength and empathy mediate the intervention's effect on mental health outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,500

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jul 2025Jun 2027

First Submitted

Initial submission to the registry

July 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

July 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

July 25, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

Couples InterventionEconomic EmpowermentGender TransformationRelationship StrengthEmpathyMental HealthGHQ-6Cluster RCTIndiaFamily Economic WellbeingMarital Relationship StrengthCouple-based Empathy

Outcome Measures

Primary Outcomes (3)

  • Mental Health Scale (General Health Questionnaire - 6)

    Change in General Health Questionnaire-6 scores (psychological distress). It is scored on a scale of 0-4, where higher score indicates higher psychological distress. Hypothesis: Greater distress reduction (or well-being increase) in the intervention group.

    T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))

  • Perceived Relationship Strength (PRS)

    Change in the composite Relationship Satisfaction Index (adapted for study); looking at trust, communication, mutual support, conflict resolution. The scale is scored on 1-5 scale, with higher score indicating higher perceived relationship score. Hypothesis: Greater improvement in the intervention group than in controls.

    T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))

  • Relational Empathy Scale (RE)

    Adapted standardized Interpersonal Reactivity Index for Couples (emotional support, perspective-taking). The scale is scored on 1-5 scale, with higher score indicating higher empathy in relationship score. Hypothesis: Larger empathy gains in the intervention group.

    T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))

Other Outcomes (7)

  • Proportion of the mental-health effect that is mediated

    T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))

  • Moderator: Gender Norm Attitudes

    T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))

  • Moderator: Household Economic Strain

    T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))

  • +4 more other outcomes

Study Arms (2)

Let's Grow Together Intervention

EXPERIMENTAL

Married couples in clusters assigned to the intervention receive a structured program of six community-based sessions. Each session lasts between 2.5 and 3 hours and includes participatory activities, discussions, and exercises. All six sessions would be conducted by the same two facilitators - one male and one female. The content integrates financial literacy (e.g., household budgeting, saving practices, joint financial planning) with gender-transformative training (e.g., equitable household roles, communication skills, conflict resolution, and fostering empathy between spouses). Sessions are delivered by trained facilitators in a group setting with fifteen couples, approximately every 2-4 weeks. Some sensitive content to address economic violence context would be done in a gender segregated manner separately to encourage reflections, ensure safety and reduce defensiveness. Between sessions, SMS reminders and tips are sent to participants' mobile phones to reinforce key messages and

Behavioral: Let us Grow Together: Economic Wellbeing for Families

No Structured Support

NO INTERVENTION

Married couples in clusters assigned to the control arm do not receive the special couples training during the study period. Participants in control group continue with standard activities and resources available in the community but without the structured sessions provided to the intervention arm. This control condition represents the status quo against which the added effect of the intervention can be measured. After the conclusion of the study, control clusters may be offered the intervention materials or sessions via the NGO partners in case investigators find overall positive treatment effects, ensuring ethical considerations are met.

Interventions

Married couples in clusters assigned to the intervention receive a structured program of six community-based sessions. Each session lasts between 2.5 and 3 hours and includes participatory activities, discussions, and exercises. All six sessions would be conducted by the same two facilitators - one male and one female. The content integrates financial literacy (e.g., household budgeting, saving practices, joint financial planning) with gender-transformative training (e.g., equitable household roles, communication skills, conflict resolution, and fostering empathy between spouses). Sessions are delivered by trained facilitators in a group setting with fifteen couples, approximately every 2-4 weeks. Some sensitive content to address economic violence context would be done in a gender segregated manner separately to encourage reflections, ensure safety and reduce defensiveness. Between sessions, SMS reminders and tips are sent to participants' mobile phones to reinforce key messages and e

Let's Grow Together Intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale: 18 - 49 years, Male: 18+
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women: 18 - 49 years, Men: 18+
  • Couples: Married and co-habitating, husband-wife pairs, who regard the selected cluster in the states Maharashtra, Andhra Pradesh, or Rajasthan of India as their primary residence for the study period.
  • Consent: Both partners provide written informed consent and agree to six sessions, baseline and endline surveys, and SMS follow-ups.
  • Education: Primary schooling (4th grade) complete
  • Comprehension: Both partners understand the local language used in sessions.
  • Availability: No plans for relocation or prolonged absence before endline.

You may not qualify if:

  • Either partner \< 18 years
  • Refusal of consent or unwillingness to participate in sessions or data collection by either partner.
  • Serious physical or mental condition that prevents safe, active participation (e.g., severe mental illness, debilitating disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

50 clusters across Maharashtra, Andhra Pradesh and Rajasthan

Mumbai, Maharashtra, India

RECRUITING

Vayam Organisation

Noida, India

NOT YET RECRUITING

Related Publications (10)

  • Falconier, M. K., Kim, J., & Lachowicz, M. J. (2023). Together-A couples' program integrating relationship and financial education: A randomized controlled trial. Journal of Social and Personal Relationships, 40(1), 333-359. https://doi.org/10.1177/02654075221118816

    BACKGROUND
  • Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.

    PMID: 18179329BACKGROUND
  • Imai K, Keele L, Tingley D. A general approach to causal mediation analysis. Psychol Methods. 2010 Dec;15(4):309-34. doi: 10.1037/a0020761.

    PMID: 20954780BACKGROUND
  • Ismayilova L, Karimli L, Gaveras E, To-Camier A, Sanson J, Chaffin J, Nanema R. An Integrated Approach to Increasing Women's Empowerment and Reducing Domestic Violence: Results of a Cluster-Randomized Controlled Trial in a West African Country. Psychol Violence. 2018 Jul;8(4):448-459. doi: 10.1037/vio0000136. Epub 2017 Aug 7.

    PMID: 34790432BACKGROUND
  • John NA, Adebayo A, Boychuk NA, OlaOlorun F. Intimate partner violence (IPV) prevention using a cross-sectoral couple-based intervention: results from a cluster randomised control trial in Ibadan, Nigeria. BMJ Glob Health. 2022 Feb;7(2):e007192. doi: 10.1136/bmjgh-2021-007192.

    PMID: 35140139BACKGROUND
  • Kim JC, Watts CH, Hargreaves JR, Ndhlovu LX, Phetla G, Morison LA, Busza J, Porter JD, Pronyk P. Understanding the impact of a microfinance-based intervention on women's empowerment and the reduction of intimate partner violence in South Africa. Am J Public Health. 2007 Oct;97(10):1794-802. doi: 10.2105/AJPH.2006.095521. Epub 2007 Aug 29.

    PMID: 17761566BACKGROUND
  • Moore, Q., Wood, R. G., & Wu, A. Y. (2023). Impacts of healthy marriage and relationship education with integrated economic stability services. Family Relations, 72(4), 1422-1440. https://doi.org/10.1111/fare.12877

    BACKGROUND
  • Peloquin K, Lafontaine MF. Measuring empathy in couples: validity and reliability of the Interpersonal Reactivity Index for couples. J Pers Assess. 2010 Mar;92(2):146-57. doi: 10.1080/00223890903510399.

    PMID: 20155564BACKGROUND
  • Raj A, Ghule M, Johns NE, Battala M, Begum S, Dixit A, Vaida F, Saggurti N, Silverman JG, Averbach S. Evaluation of a gender synchronized family planning intervention for married couples in rural India: The CHARM2 cluster randomized control trial. EClinicalMedicine. 2022 Mar 5;45:101334. doi: 10.1016/j.eclinm.2022.101334. eCollection 2022 Mar.

    PMID: 35274093BACKGROUND
  • Rao KN, Begum S, Siddappa K, Ravindra K. Validity of a 6-item version of general health questionnaire (g.h.q.) in the hands of a non - psychiatrist. Indian J Psychiatry. 1992 Apr;34(2):145-7.

    PMID: 21776115BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Janina Steinert, Prof. Dr.

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Researcher

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 6, 2025

Study Start

July 29, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. However, fully anonymized datasets may be shared with project partners and qualified researchers working on related topics (e.g., mental health and economic violence) for secondary analyses, including cross-country or pooled analyses, subject to data sharing agreements and ethical approvals. Timeframe: Anonymized data may be shared beginning in 2026, following primary publications. Access Criteria: Available on request upon approval by overall study PI Prof. Dr. Steinert

Locations