跳至主要内容
临床试验/NCT07108049
NCT07108049招募中不适用

A Randomized Controlled Trial of a Couple-Based Economic Empowerment Intervention to Improve Relationship Quality and Mental Health in Three States of India

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2025年7月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
4,500
试验地点
2
主要终点
Mental Health Scale (General Health Questionnaire - 6)

研究概览

简要总结

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.

详细描述

Studies report that couples-based programs combining financial or economic empowerment content with gender-equity and relationship-building components often yield improved relationship quality. For example, a study for low-income African-American couples describe a 20-hour workshop that significantly reduced stress and improved conflict management and relationship satisfaction at 6 months. Another study observed improved overall relationship quality among low-income couples with children, while studies from Nigeria and India document enhanced communication, trust, and joint decision-making-with adjusted relative odds for improved communication.

Interventions that combine microfinance or business training with participatory gender or relationship education report reductions in intimate partner violence-one study noted a reduction in risk by more than 50%-and improved empowerment through enhanced decision-making.

Measures of mental health and well-being, such as stress reduction and improved financial autonomy, also improved in several evaluations, although mental health outcomes appear less consistently reported than relationship outcomes. Notably, partner empathy was not an explicitly measured outcome in any study. Programs varied in intensity-from 4-8 sessions and multi-day trainings to interventions extending over 24 months-and were implemented in diverse contexts spanning low-income and rural communities in the United States, Africa, and South Asia.

This sub-study provides a focused evaluation of psychosocial outcomes within the broader "Let us Grow Together: Economic Wellbeing for Families" intervention. The main trial is designed to improve families' economic well-being through financial literacy training, while also integrating gender-transformative content to address intra-household dynamics. The sub-study specifically evaluates program impacts on marital relationship quality and mental health. It is premised on the idea that empowering couples with financial skills and promoting equitable, empathetic relationships can strengthen partner bonds and reduce psychological distress.

Participants in the intervention arm attend six structured community-based sessions for couples. These sessions blend financial literacy education (e.g. budgeting, savings, financial planning) with content on gender equity, communication, and shared decision-making. The curriculum is gender-transformative, meaning it challenges traditional gender roles and encourages empathy and cooperation between spouses. Sessions are interactive and participatory, fostering dialogue on relationship expectations, emotional support, and joint problem-solving. Between sessions, couples receive SMS text message reinforcements to encourage practice of the skills learned and to sustain engagement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

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

干预措施: Let us Grow Together: Economic Wellbeing for Families (Behavioral)

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.

结局指标

主要结局

Mental Health Scale (General Health Questionnaire - 6)

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

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.

Perceived Relationship Strength (PRS)

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

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.

Relational Empathy Scale (RE)

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

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.

次要结局

未报告次要终点

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anushree Dirangane

PhD Researcher

Technical University of Munich

研究点 (2)

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