CompletedNot Applicable

The TARANG Intervention

India42 participantsStarted 2023-07-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of the Intervention

Timeframe: Post-intervention at 5 month endline survey

Acceptability

Timeframe: Post-intervention at 5 month endline survey

Usefulness

Timeframe: Post-intervention at 5 month endline survey

Trial details

NCT IDNCT06320964

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-21

Results submitted2024-07-05

View on ClinicalTrials.gov More Feasibility trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.