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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD108252 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Network for Engineering and Economics Research and Management | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Vikalp Sansthan | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Newly married women:
Husbands:
Mothers-in-law:
Exclusion Criteria:
Newly married women:
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| Name | Affiliation | Role |
|---|---|---|
| Nadia Diamond-Smith, PhD, MS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vikalp Sansthan | Udaipur | Rajasthan | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41241746 | 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 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. | |
| 40916629 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TARANG Arm | Received 16 lifeskills and reproductive health empowerment sessions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TARANG Arm | A single-arm trial in which intervention groups receive an introductory rapport-building session, followed by 16 group sessions facilitated by the moderators over six months. The intervention used practical skill-building activities to empower participants by enhancing their understanding of fundamental topics such as menstruation, conception, and contraception. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Intervention | Proportion of participants who complete 50% of the intervention sessions | The outcome was only analyzed for those participants who attended at least one session. | Posted | Count of Participants | Participants | Post-intervention at 5 month endline survey |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TARANG Arm | A single-arm trial in which intervention groups receive an introductory rapport-building session, followed by 16 group sessions facilitated by the moderators over six months. The intervention used practical skill-building activities to empower participants by enhancing their understanding of fundamental topics such as menstruation, conception, and contraception. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadia Diamond-Smith, PhD, MS | University of California, San Francisco | (415) 502-5800 | nadia.diamond-smith@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 2, 2023 | Jul 5, 2024 | Prot_SAP_ICF_000.pdf |
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| 39483877 | 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. |
| 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. Reprod Health. 2024 Oct 17;21(1):147. doi: 10.1186/s12978-024-01878-y. |
| 38798481 | 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. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| Primary | Acceptability | Proportion of participants who were completely or somewhat satisfied with the intervention | Only participants who attended at least one session were analyzed. | Posted | Count of Participants | Participants | Post-intervention at 5 month endline survey |
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| Primary | Usefulness | Proportion of participants who found the TARANG intervention sessions very useful or somewhat useful | Only those who attended at least one session were asked about usefulness of sessions. | Posted | Count of Participants | Participants | Post-intervention at 5 month endline survey |
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| 0 |
| 42 |
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| 42 |
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| 42 |
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