The TARANG Intervention

NCT06320964 | Completed Results

• 2 other identifiers: R01HD108252_1R01HD108252
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Feasibility; Acceptability; Family Planning; Unintended Pregnancy

Outcome Measures

Primary Outcomes (3)

• Feasibility of the Intervention

  Proportion of participants who complete 50% of the intervention sessions

  Post-intervention at 5 month endline survey

• Acceptability

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

  Post-intervention at 5 month endline survey

• Usefulness

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

  Post-intervention at 5 month endline survey

Study Arms (1)

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.

Behavioral: TARANG

Interventions

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.

TARANG arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Network for Engineering and Economics Research and Management: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Vikalp Sansthan: collaborator

Study Sites (1)

Vikalp Sansthan

Udaipur, Rajasthan, India

Location

Related Publications (5)

• Gopalakrishnan L, Patil S, Das D, Paul A, Sharma P, Kachhwaha A, Choudhary U, Diamond-Smith N. Feasibility and acceptability of a life skills and reproductive health empowerment intervention for young newly married women in Rajasthan, India: a pre-post convergent mixed methods pilot study. Pilot Feasibility Stud. 2025 Nov 15;11(1):142. doi: 10.1186/s40814-025-01720-7.

  PMID: 41241746 DERIVED

• Gopalakrishnan L, Choudhary U, Vallin J, Das D, Sharma P, Kachhwaha A, Panjalingam T, Ruwala R, Diamond-Smith N. Implementation and evaluation of a family planning intervention engaging mothers-in-law of young women in India: a mixed methods pilot study. Glob Health Action. 2025 Dec;18(1):2554435. doi: 10.1080/16549716.2025.2554435. Epub 2025 Sep 8.

  PMID: 40916629 DERIVED

• Gopalakrishnan L, Patil S, Das D, Paul A, Sharma P, Kachhwaha A, Choudhary U, Diamond-Smith N. Feasibility and acceptability of a life skills and reproductive health empowerment interventionfor young newly married women in Rajasthan, India: A pre-post convergent mixed methods pilot study. Res Sq [Preprint]. 2024 Oct 16:rs.3.rs-4255712. doi: 10.21203/rs.3.rs-4255712/v1.

  PMID: 39483877 DERIVED

• Diamond-Smith N, Vaishnav Y, Choudhary U, Sharma P, Kachhwaha A, Panjalingam T, Vallin J, Das D, Gopalakrishnan L. Individual empowerment and community norm effects of engaging young husbands in reproductive health in rural India: findings from a pilot study. Reprod Health. 2024 Oct 17;21(1):147. doi: 10.1186/s12978-024-01878-y.

  PMID: 39420379 DERIVED

• Diamond-Smith N, Vaishnav Y, Choudhary U, Sharma P, Kachhwaha A, Panjalingam T, Vallin J, Das D, Gopalakrishnan L. Individual empowerment and community norm effects of engaging young husbands in reproductive health in rural India: findings from a pilot study. Res Sq [Preprint]. 2024 May 15:rs.3.rs-4376443. doi: 10.21203/rs.3.rs-4376443/v1.

  PMID: 38798481 DERIVED

Results Point of Contact

• Title: Nadia Diamond-Smith, PhD, MS
• Organization: University of California, San Francisco

nadia.diamond-smith@ucsf.edu

(415) 502-5800

Study Officials

• Nadia Diamond-Smith, PhD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: July 14, 2023
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2024
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)