The TARANG Intervention

Feasibility Clinical Trial

— TARANG Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06320964
• Other study ID #: R01HD108252_1
• Secondary ID: R01HD108252
• Status: Completed
• Phase: N/A
• Start date: July 14, 2023
• Est. completion date: January 21, 2024

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 21, 2024
• Est. primary completion date: January 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acceptability
• Family Planning
• Feasibility
• Unintended Pregnancy

Intervention

Behavioral:
• TARANG
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.

Locations

Country	Name	City	State
India	Vikalp Sansthan	Udaipur	Rajasthan

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Network for Engineering and Economics Research and Management, Vikalp Sansthan

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention	Proportion of participants who complete 50% of the intervention sessions	Post-intervention at 5 month endline survey
Primary	Acceptability	Proportion of participants who were completely or somewhat satisfied with the intervention	Post-intervention at 5 month endline survey
Primary	Usefulness	Proportion of participants who found the TARANG intervention sessions very useful or somewhat useful	Post-intervention at 5 month endline survey