- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06320964
The TARANG Intervention (TARANG Pilot)
Feasibility and Acceptability of a Group-based Life Skills-integrated Reproductive Health Empowerment Intervention for Newly Married Women, Husbands, and Mothers-in-law
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rajasthan
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Udaipur, Rajasthan, India
- Vikalp Sansthan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TARANG arm
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the intervention
Time Frame: Post-intervention at 5 month endline survey
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Proportion of participants who complete 50% of the intervention sessions
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Post-intervention at 5 month endline survey
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Acceptability
Time Frame: Post-intervention at 5 month endline survey
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Proportion of participants who were completely or somewhat satisfied with the intervention
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Post-intervention at 5 month endline survey
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Usefulness
Time Frame: Post-intervention at 5 month endline survey
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Proportion of participants who found the TARANG intervention sessions very useful or somewhat useful
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Post-intervention at 5 month endline survey
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nadia Diamond-Smith, PhD, MS, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R01HD108252_1
- R01HD108252 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on TARANG
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SangathLondon School of Hygiene and Tropical Medicine; Public Health Foundation of...CompletedHealth PromotionIndia