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Completed

NCT Number: NCT06320964

The TARANG Intervention

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.

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Key information

Conditions

Feasibility Acceptability Family Planning Unintended Pregnancy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vikalp Sansthan

Udaipur, Rajasthan, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Husbands:

  • 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

Exclusion criteria

Newly married women:

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

Treatment and study plan

TARANG

Behavioral

For newly married women, the intervention had one introductory rapport-building session, followed by 16 group sessions facilitated by trained female moderators over 5 months. The intervention aimed to empower participants by enhancing their understanding of fundamental topics such as menstruation, conception, and contraception, choice of a method among others. Sessions also covered topics to strengthen participants' sense of agency and their ability to make informed decisions regarding family planning and the timing of their first childbirth. Similarly, for husbands, a male moderator delivered sessions on four topics: Love, Relationships and Expectations; Conception and Health; Contraception Methods, and how to choose family planning methods. For MILs, a female moderator covered four sessions: Nutrition flag, Conception and Health, communication between family members, and the final session on relationships with daughter-in-law.

Primary outcomes

  1. Feasibility of the Intervention

    Time frame: Post-intervention at 5 month endline survey

    Proportion of participants who complete 50% of the intervention sessions

  2. Acceptability

    Time frame: Post-intervention at 5 month endline survey

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

  3. Usefulness

    Time frame: Post-intervention at 5 month endline survey

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Network for Engineering and Economics Research and Management
  • Vikalp Sansthan

Registry information

Official study title

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

Acronym: TARANGPilot

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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