- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07595029
Co-designing Adaptations of a Digital Mental Health Intervention (Wysa) for Adolescent Girls With Anxiety or Depression in Rural India
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
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.
연구 개요
상세 설명
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:
The study will be conducted across the 5 districts of Bahraich, Barabanki, Hardoi, Lucknow, and Sitapur in Uttar Pradesh.
One-on-one or group Awareness sessions will be conducted in Hindi and/or English (based on their preference) to recruit community stakeholders, adolescent girls, and parents/ guardians in each district. All communication will be age-appropriate and emphasize voluntary participation and confidentiality. The goal of the awareness activities is to build culturally relevant mental health understanding, provide clear study information for informed participation, and allow individuals to reflect on their experiences and interests.
Study Activities:
This study is a sequential study with 122-179 participants and will be conducted in 3 phases. Quota-based purposive sampling will be utilized to select adolescent girls in each district (N=60-90). Further, parents/ guardians of participating adolescents in each district (N=35-50), key community stakeholders in each district (N=25-35); and 2-4 decision makers will be selected using a targeting purposive sampling criteria. Data collection methods include participatory co-design focus group workshops and supplementary interviews, rapid ethnography, and Delphi surveys.
All selected participants will receive access to versions of Wysa to try out before the participatory workshops begin. Participatory workshops will be conducted seperately with adolescent girls, parents/ guardians of adolescent girl participants, and key community stakeholders to identify the barriers and enablers to adoption and engagement of Wysa app. Additionally, semi-structured individual interviews with a subset of adolescent girl participants will be conducted to further explore their in-depth perspectives. Next, Two rounds of Delphi surveys will be conducted in a participatory workshop a mixed-group of purposively sampled participants to prioritise and rate the identified barriers that have emerged from the previous phase of the participatory workshops and corresponding strategies against the APEASE criteria. Lastly, a final adaptation roadmap of key barriers to address and solutions to implement will be developed in a participatory workshop with a purposively sampled mixed sub-group of 18-24 participants.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Chaitali Sinha
- 전화번호: +16262368661
- 이메일: chaitali@wysa.io
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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-25.
- 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 Exclusion Criteria:
- 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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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:
|
Wysa is a digital psychosocial tool that provides AI conversational chatbot support. The conversational agent acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT), mindfulness, and motivational intervention. Users can learn different techniques and practice them in their daily life. The app also provides a repository of tools to manage problems and SOS resources for high distress In Aim 1 study (which is part of larger 5 year project), participants will recieve the current version of the digital psychosocial tool to provide their feedback. It is not being used as an intervention in this Aim 1 study |
|
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
|
Wysa is a digital psychosocial tool that provides AI conversational chatbot support. The conversational agent acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT), mindfulness, and motivational intervention. Users can learn different techniques and practice them in their daily life. The app also provides a repository of tools to manage problems and SOS resources for high distress In Aim 1 study (which is part of larger 5 year project), participants will recieve the current version of the digital psychosocial tool to provide their feedback. It is not being used as an intervention in this Aim 1 study |
|
Adolescent Girls
Adolescent girl participants from diverse backgrounds such as age, caste, religion, geographical location, phone ownership, and literacy levels will be included .
|
Wysa is a digital psychosocial tool that provides AI conversational chatbot support. The conversational agent acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT), mindfulness, and motivational intervention. Users can learn different techniques and practice them in their daily life. The app also provides a repository of tools to manage problems and SOS resources for high distress In Aim 1 study (which is part of larger 5 year project), participants will recieve the current version of the digital psychosocial tool to provide their feedback. It is not being used as an intervention in this Aim 1 study |
|
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).
|
Wysa is a digital psychosocial tool that provides AI conversational chatbot support. The conversational agent acts as a companion, and understands, empathizes, and guides users through exercises grounded in cognitive behavioral therapy (CBT), mindfulness, and motivational intervention. Users can learn different techniques and practice them in their daily life. The app also provides a repository of tools to manage problems and SOS resources for high distress In Aim 1 study (which is part of larger 5 year project), participants will recieve the current version of the digital psychosocial tool to provide their feedback. It is not being used as an intervention in this Aim 1 study |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
List of Final Wysa Adaptations and Implementation strategies
기간: 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
|
From enrollment until end of particpatory workshops at Month 6
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 26-WYSA-01
- 321110/Z/24/Z (기타 보조금/기금 번호: Wellcome Trust)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Digital psychosocial tool에 대한 임상 시험
-
Weill Medical College of Cornell University알려지지 않은
-
Icahn School of Medicine at Mount SinaiNorthwestern University; The Cleveland Clinic; University of California, Davis; RxHealth완전한
-
Necmettin Erbakan UniversityKonya City Hospital모병
-
Columbia UniversityNational Institute of Nursing Research (NINR)완전한
-
Carilion ClinicDigitally Enhanced Screening Applications빼는
-
Brigham and Women's Hospital완전한
-
Scripps Whittier Diabetes InstituteSan Diego State University; University of California, San Diego완전한
-
Mount Sinai Hospital, CanadaMOUNT SINAI HOSPITAL; Trillium Health Partners모병
-
Boston Children's Hospital모집하지 않고 적극적으로