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FeasibilityTARANGPilotNCT06320964

The TARANG Intervention

A study testing TARANG in people with Feasibility and Acceptability, run by University of California, San Francisco at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Feasibility, Acceptability, Family Planning
What is being tested?
TARANG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteIndia
Study dates
14 Jul 2023to 21 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 15Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Vikalp Sansthan

    Udaipur, Rajasthan

Other trials in India

About this study

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

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.

Read the detailed 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.

Being tested
TARANG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TARANGBehavioural

    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.

Study groups in NCT06320964
Study groupRoleWhat they receive
TARANG armExperimentalThe 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.
Receives: Behavioral: TARANG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the Intervention

    Proportion of participants who complete 50% of the intervention sessions

    Measured: Post-intervention at 5 month endline survey

  2. Acceptability

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

    Measured: Post-intervention at 5 month endline survey

  3. Usefulness

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

    Measured: Post-intervention at 5 month endline survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start14 Jul 2023
  3. Primary completion21 Jan 2024
  4. Study completion21 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06320964
Sponsor's protocol ID
R01HD108252_1
Other IDs
R01HD108252
Acronym
TARANGPilot
Status last verified
Feb 2025
First submitted
13 Mar 2024
Last updated
6 Feb 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41241746

  • 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.

    PubMed 40916629

  • 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.

    PubMed 39483877

  • 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.

    PubMed 39420379

  • 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.

    PubMed 38798481

Questions about this trial

What is this clinical trial studying?

A study testing TARANG in people with Feasibility and Acceptability, run by University of California, San Francisco at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the Intervention (time frame: Post-intervention at 5 month endline survey). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06320964, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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