Clinical trial NCT06320964: The TARANG Intervention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility
Acceptability
Family Planning
Unintended Pregnancy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Network for Engineering and Economics Research and Management
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Vikalp Sansthan
First posted: 2024-03-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: Post-intervention at 5 month endline survey
measure: Acceptability
timeFrame: Post-intervention at 5 month endline survey
measure: Usefulness
timeFrame: Post-intervention at 5 month endline survey
Secondary outcomes:
Other outcomes:
Locations:
city: Udaipur
country: India
facility: Vikalp Sansthan
state: Rajasthan
Study officials:
affiliation: University of California, San Francisco
name: Nadia Diamond-Smith, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: