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临床试验/NCT07595029
NCT07595029尚未招募不适用

Identifying Barriers and Enablers to Co-Design Adaptations of a Digital Mental Health Intervention (Wysa) for Adolescent Girls in Low Resource Settings in Uttar Pradesh, India

Wysa0 个研究点目标入组 179 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
Wysa
入组人数
179
主要终点
List of Final Wysa Adaptations and Implementation strategies

研究概览

简要总结

The goal of this study is to culturally and contextually adapt Wysa, an evidence-based AI-powered digital mental health intervention (DMHI), for adolescent girls (ages 13-18) with symptoms of anxiety and/or depression in rural Uttar Pradesh, India.

More specifically, the aims of this study are to (i) explore key barriers and facilitators to adoption, engagement, and usability of a digital mental health intervention (Wysa) in this setting, and to (ii) co-design contextually appropriate app adaptations and implementation strategies in collaboration with adolescent girls, their parents/guardians, and community stakeholders. At the end of this study, we would have co-developed a roadmap of potential adaptations to Wysa with implementation strategies to iteratively test and develop during the next phases of the study.

详细描述

STUDY OBJECTIVES

Primary Objective:

To develop a stakeholder-endorsed roadmap of Wysa app adaptations and implementation strategies to guide the next phases of the project, ensuring that Wysa is accessible, culturally appropriate, and responsive to the needs of adolescent girls in rural Uttar Pradesh, India.

METHODS

Recruitment Procedures:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ADOLESCENTS:
  • Inclusion Criteria:
  • Sex: girls
  • Marital status: Unmarried
  • Are between 13-18 years of age
  • Residing in the selected villages of Uttar Pradesh, India.
  • Have elevated anxiety and/or depressive symptoms on the RCADS-
  • Have access to a mobile phone (at least 1 mobile phone within the family).
  • Provide assent/ consent to participate, along with guardian consent for minors.
  • Adolescents

排除标准

  • Adolescent girls who have difficulties that would prevent them from actively participating in workshop activities (e.g. with memory or comprehension, indications of psychoses)
  • Are currently or have been in the past a girl icon in the Milaan Foundation Girl Icon program
  • PARENTS/GUARDIANS:
  • Inclusion Criteria
  • Are guardians or caregivers of a participating adolescent girl.
  • Currently reside in Uttar Pradesh
  • Provide informed consent to participate.
  • Exclusion Criteria ● They have difficulties that would prevent them from actively participating in workshop activities (e.g. with memory or comprehension, indications of psychoses).
  • COMMUNITY STAKEHOLDERS & DECISION MAKERS
  • Inclusion criteria
  • Contribute to and influence local health related-decisions or services.
  • Provide informed consent to participate.
  • Exclusion Criteria ● Stakeholders who have difficulties that would prevent them from actively participating in workshop activities (e.g. with memory or comprehension, indications of psychoses)

研究组 & 干预措施

Community Stakeholders

Community stakeholders will be strategically sampled to capture different areas of work art a village level that intersect or impact with adolescent well being including:

  • Community leaders (e.g. panchayat, district and/or state officials)
  • Individuals providing well-being or mental health services
  • Local health workers (e.g. ASHAs, ANMs, Community Health & Sanitation Committee representatives)
  • NGO representatives in adolescent programmes
  • School staff (e.g. teacher, principal)

干预措施: Digital psychosocial tool (Behavioral)

Parents/Guardians

Parents or guardians of adolescent girl participants across diverse caste, , religious, phone ownership, and ages will be included. Parents/ guardians of different genders will included

干预措施: Digital psychosocial tool (Behavioral)

Adolescent Girls

Adolescent girl participants from diverse backgrounds such as age, caste, religion, geographical location, phone ownership, and literacy levels will be included .

干预措施: Digital psychosocial tool (Behavioral)

Decision Makers

Individuals who work at the district or state level, and in different areas of work that intersect with adolescent wellbeing (such as education, health etc).

干预措施: Digital psychosocial tool (Behavioral)

结局指标

主要结局

List of Final Wysa Adaptations and Implementation strategies

时间窗: From enrollment until end of particpatory workshops at Month 6

A finalized adaptation roadmap will be developed including changes to be made in Wysa and implementation strategies to be executed to impove Wysa access and use

次要结局

未报告次要终点

研究者

发起方
Wysa
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Chaitali Sinha

Chief Clinical R&D Officer

Wysa

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