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Идёт набор NCT07108049

Strengthening Relationships and Mental Health Through a Couples-Based Economic Empowerment Intervention

Без фазы С лечением Mental Health Empathy Relation, Interpersonal

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Let us Grow Together: Economic Wellbeing for Families.
Кому может быть актуально
Состояния в реестре: Mental Health, Empathy, Relation, Interpersonal. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

The study uses a cluster randomized controlled trial design to avoid contamination between participants. Clusters (such as villages or community centers) are randomly assigned to either the intervention or control arm by an external trial statistician. All eligible couples within intervention clusters receive the couples' sessions program, whereas couples in control clusters do not receive any structured intervention during the study period (control participants continue with services as usual). Both arms undergo identical baseline and endline assessments. The endline survey, conducted after completion of the six sessions, collects data on relationship strength, empathy, and mental health to measure changes from baseline. By comparing these changes between the intervention and control arms, the study will estimate the intervention's causal effect on the targeted outcomes.

In addition to direct outcome evaluation, an exploratory mediation analysis is planned. This analysis will test whether any improvement in mental health (GHQ-6 scores) due to the intervention occurs indirectly through enhanced relationship strength and empathy. In other words, the study will examine if the intervention's effect on participants' mental well-being is mediated by stronger couple relationships and greater spousal empathy. This will help elucidate the mechanism of impact: whether the economic and gender content improves mental health by improving how partners relate to and support each other. Findings from this sub-study will contribute to understanding the added value of integrating relationship-building and gender equity components into economic empowerment programs for families.

Вмешательства

  • Поведенческое Let us Grow Together: Economic Wellbeing for Families
    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 ro

Первичные конечные точки

  • Mental Health Scale (General Health Questionnaire - 6) [Срок оценки: T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))]
  • Perceived Relationship Strength (PRS) [Срок оценки: T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))]
  • Relational Empathy Scale (RE) [Срок оценки: T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Индия · 2 центра
  • 50 clusters across Maharashtra, Andhra Pradesh and Rajasthan — Mumbai
  • Vayam Organisation — Noida

Публикации

  • 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
  • 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 18179329
  • 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 20954780
  • 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 34790432
  • 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 35140139
  • 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 17761566
  • 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
  • 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 20155564

Идентификаторы

NCT: NCT07108049 · TUM-EcoVi-01 · ECOVI, 101115963

Первоисточники (государственные реестры)

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