Feasibility Clinical Trial
— TARANG PilotOfficial title:
Feasibility and Acceptability of a Group-based Life Skills-integrated Reproductive Health Empowerment Intervention for Newly Married Women, Husbands, and Mothers-in-law
Verified date | March 2024 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
India | Vikalp Sansthan | Udaipur | Rajasthan |
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 |
India,
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 |
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