"One All" to Get it RYT (Resilient Young Tribal Adults): A Multi Centric, Participatory,Feasibility and Effectiveness Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
- Enrollment
- 240
- Locations
- 3
- Primary Endpoint
- Resilience meaured by the Child Youth Resilience Measure (CYRM) - a 28 item questionnaires
Study Overview
Brief Summary
:The study is designed to introduce a curriculum "One All", organised around the sport, Ultimate Frisbee, as a way to improve mental health resilience. This research will examine the feasibility and effectiveness of the intervention in two locations, Gudalur in Tamil Nadu and BR Hills in Karnataka.
Objectives:
The primary objective is to assess the feasibility and acceptability of "One All" intervention among young people, evaluate its key component of facilitators training programme and assess its effectiveness in improving the mental health and resilience, in two tribal communities in South India.
Methods:
The effectiveness of the intervention (One All) will be evaluated at three time points at 12 months and 18 months. Phase i and 2 will be training of facilitators and focussed group discussion with elders and other significant others.
Phase 3 Includes; A quantitative assessment of the intended outcomes of curriculum at the end of the intervention. This will be a pre-post study (n=119) each for boys and girls).The outcomes will be assessed at 12 months and 18 months of intervention.
The sports based psychosocial curriculum "OneAll' is assessed as feasible and effective amongst the tribal young people in south India.
Detailed Description
The research activities of phase 1 and 2 will include purposively recruiting participants for focus group discussion and in-depth interviews. The implementation team will help us identify the key stakeholders in the communities. While the consent form for key stakeholder will be used for all other participants of phase 1 and 2, the consent for phase 1, 2 and 3 for young adults will be covered under 1) consent for parents, if age of participants in intervention is less than 18 and 2) participant consent if they are above 18. Phase 3 of research will follow different process. Phase 3 for children to participate in the study, who are of age less than 18, the parents will be contacted for consent, first a set of screening questions will be asked to determine the eligibility of the participant for the study, once found eligible, a baseline interview will be conducted for collecting non-identifiable socio-demographic, data of the family. The informed consent is sought at this point. The participant will undergo the interviews for the validated questionnaires at 3 time points. Once before the intervention starts, once after 12 months of intervention and once after 18 months of intervention. The consent form for parents to seek permission for participation of the these participants covers all the three phases of the study.
Screening and recruitment process: The screening will be a verbal process where the participants will be assessed whether they are eligible for participation.
The baseline interview to collect data of the non-identifiable socio-demographic data. The data points to be collected are; 1) details about the land ownership, 2)cattle ownership, 3) type of house, 4) nature of family income, 5) source of water, 6)electricity, 7) material possessions at 'your' (participant's) home (TV, two-wheeler, mobile phone).These details will be used for understanding the socio-economic differences among the participants.
Those who qualify to take part in this research study will attend two or more, one and half hour sessions every week, for the duration of one year.
They will be assigned a code (name/village/household information will not appear in any document) and placed in one of the 'One-all' groups. Each of the 'One-all' groups will have approximately 20 participants (which will undergo organized sessions and ultimate frisbee game for the duration of the study). The following questionnaires will be administered to the participants as part of evaluation:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All participants who are tribals and are recruited for One-all intervention
Exclusion Criteria
- •All participants who are recruited for One-all intervention, but, are nottribals.
- •ii. Any child joining the programme subsequently after the baseline measuresare taken and the first session is delivered will not be recruited.
- •iii. If a participant is not fluent in any of the languages listed, they will not beable to participate in the research study.
Arms & Interventions
A prospective dual site intervention in India
The study will utilize a pre-post study design to evaluate the intervention for intendedoutcomes at the end of Year 1.
Intervention: "One All" Intervention (Behavioral)
Outcomes
Primary Outcomes
Resilience meaured by the Child Youth Resilience Measure (CYRM) - a 28 item questionnaires
Time Frame: The assessments will be done ar baseline, at 12 months and 18 months..
To evaluate effectiveness for increasing primary outcome of changed resilience using the Child Youth Resilience Measure (CYRM) - a 28 item questionnaires.The range of scoring is 28 to 140.
Resilience
Time Frame: The assessments will be done ar baseline, at 12 months and 18 months.
To evaluate effectiveness for increasing primary outcome of changed resilience using the Connor-Davidson resilience scale (CD- RISC) using the 10-question scale to measure resilience.The full range of CD-RISC is 0 to 100.
Secondary Outcomes
- Mental Health(The assessments will be done ar baseline, at 12 months and 18 months.)
- Mental Health as measured by GHQ12(The assessments will be done ar baseline, at 12 months and 18 months.)
Investigators
Vishwajit Nimgaonkar, MD PhD
Professor
University of Pittsburgh