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临床试验/NCT06320964
NCT06320964已完成不适用

Feasibility and Acceptability of a Group-based Life Skills-integrated Reproductive Health Empowerment Intervention for Newly Married Women, Husbands, and Mothers-in-law

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Feasibility of the Intervention

研究概览

简要总结

The mixed methods pilot study aims to evaluate the acceptability, feasibility, and implementation challenges of the TARANG intervention in villages in rural/tribal Rajasthan to inform the study design and operational details for a larger cluster-randomized controlled trial.

详细描述

Participants will participate in the single group in the TARANG intervention arm and receive the sessions that will enable them to navigate newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills), improve participants awareness of sexual reproductive health, enable participants to challenge inequitable gender norms to reduce unintended pregnancies.

Newly married women (daughters-in-law) received 17 sessions; husbands received 4 sessions and mothers-in-law received 4 sessions. The sessions are implemented by NGO partner, Vikalp Sansthan via trained facilitators/moderators who are supervised by NGO staff.

In this mixed methods pilot study, we aimed to qualitatively understand the participants' acceptability, feasibility of the TARANG intervention delivery, content, modules, etc. We also aimed to capture the qualitative impact of the TARANG intervention and pilot activities in communities/villages as well as to understand the operational challenges of delivery from participants and NGO moderators (key informants) delivering the intervention. Quantitative pre- and post-surveys were conducted to understand implementation outcomes such as feasibility, acceptability, and satisfaction, among other outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Newly married women:
  • Age 18-25 years at the time of wedding
  • Does not plan to move out of the area for the period of the intervention
  • Mother-in-law has agreed to support daughter-in-law's participation in the study
  • Mother-in-law and husband are eligible for the study participation
  • 18 years or more at the time of the wedding
  • Does not plan to move out of the village during period of the intervention
  • Mother and wife are eligible for study participation
  • Mothers-in-law:
  • Has a daughter-in-law who is eligible and willing to participate in the study
  • Provides individual consent to participate in the study
  • Assents for daughter-in-law to participate in the study
  • Does not plan to move out of the village during period of the intervention
  • The son and the daughter-in-law are eligible for study participation

排除标准

  • Newly married women:
  • Wanting to have a child in the next 12 months at the time of baseline
  • Cognitive ability to participate in surveys

研究组 & 干预措施

TARANG arm

Experimental

The newly married women received 16 weekly group sessions and one rapport-building session, while the husbands and mothers-in-law received four group sessions each over four months. The TARANG intervention was delivered via gender-matched moderators from Vikalp Sansthan and uses three overarching themes: sexual and reproductive health, gender norms, and empowerment.

干预措施: TARANG (Behavioral)

结局指标

主要结局

Feasibility of the Intervention

时间窗: Post-intervention at 5 month endline survey

Proportion of participants who complete 50% of the intervention sessions

Acceptability

时间窗: Post-intervention at 5 month endline survey

Proportion of participants who were completely or somewhat satisfied with the intervention

Usefulness

时间窗: Post-intervention at 5 month endline survey

Proportion of participants who found the TARANG intervention sessions very useful or somewhat useful

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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