Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474260
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
One All to Get it RYT Resilient Young Tribal Adults
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
One All to Get it RYT Resilient Young Tribal Adults A Multi Centric ParticipatoryFeasibility and Effectiveness Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n119 each for boys and girlsThe 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
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 n119 each for boys and girlsThe 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 2cattle ownership 3 type of house 4 nature of family income 5 source of water 6electricity 7 material possessions at your participants home TV two-wheeler mobile phoneThese 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 namevillagehousehold 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
1 Connor-Davidson resilience scale CD- RISC to measure participants capacity to bounce back from adversities
2 The Child Youth Resilience Measure CYRM - to measure participants capacity to bounce back from adversities
3 GHQ12 a validated measure of participants mental well-being
4 Schwarzers General Self-Efficacy Scale GSE to measure participants self-efficacy
Questionnaires 1-4 will be administered at 3 time points First time point is the baseline before the first One-all session second time point will be at the end of 12 months of receiving one-all sessions and third time point will be after 18 months of receiving One-all sessions as EndlineThe participant will undergo intervention provided by the One-all implementation team Implementation team will visit the communities for enrolling the participants for the intervention This team will pass on the list of participants who have enrolled for the intervention to the research team
One-all programme delivery by implementation team separate from research The three-year curriculum is structured as a series of chapters followed by a year-end event usually a workshop or a tournament Each chapter begins with an introduction that outlines the major content of the chapter with topics and their objectives Lesson plans have been created by the One All curriculum development team for each of these topics
Each session is designed to take maximum of one and half hours The suggested time is considered the components However the lessons can always be expanded on a given day or spread out over one or more days for deeper and more graduated learning as time permits Each session has the following 4 parts
1 Warm up provides the opportunity to prepare the children to become familiar with the learning topic for the day through a fun activity that is related to the topic
2 Drills are sporting activities that are more physically involved but also connected to the application of the learning topic
3 Game is a mixed-gender ultimate frisbee match with modified rules to emphasize the application of the learning topic
4 Spirit circle Group discussion that is used to reflect and share the learning of the day It also guides children in making thoughtful connections that anchor the learning
The implementation team will keep the records pertaining to attendance and the reflections of the sessions in detail The research team will use these records No medical records will be accessed through the course 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 2cattle ownership 3 type of house 4 nature of family income 5 source of water 6electricity 7 material possessions at your participants home TV two-wheeler mobile phoneThese 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 namevillagehousehold 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
1 Connor-Davidson resilience scale CD- RISC to measure participants capacity to bounce back from adversities
2 The Child Youth Resilience Measure CYRM - to measure participants capacity to bounce back from adversities
3 GHQ12 a validated measure of participants mental well-being
4 Schwarzers General Self-Efficacy Scale GSE to measure participants self-efficacy
Questionnaires 1-4 will be administered at 3 time points First time point is the baseline before the first One-all session second time point will be at the end of 12 months of receiving one-all sessions and third time point will be after 18 months of receiving One-all sessions as EndlineThe participant will undergo intervention provided by the One-all implementation team Implementation team will visit the communities for enrolling the participants for the intervention This team will pass on the list of participants who have enrolled for the intervention to the research team
One-all programme delivery by implementation team separate from research The three-year curriculum is structured as a series of chapters followed by a year-end event usually a workshop or a tournament Each chapter begins with an introduction that outlines the major content of the chapter with topics and their objectives Lesson plans have been created by the One All curriculum development team for each of these topics
Each session is designed to take maximum of one and half hours The suggested time is considered the components However the lessons can always be expanded on a given day or spread out over one or more days for deeper and more graduated learning as time permits Each session has the following 4 parts
1 Warm up provides the opportunity to prepare the children to become familiar with the learning topic for the day through a fun activity that is related to the topic
2 Drills are sporting activities that are more physically involved but also connected to the application of the learning topic
3 Game is a mixed-gender ultimate frisbee match with modified rules to emphasize the application of the learning topic
4 Spirit circle Group discussion that is used to reflect and share the learning of the day It also guides children in making thoughtful connections that anchor the learning
The implementation team will keep the records pertaining to attendance and the reflections of the sessions in detail The research team will use these records No medical records will be accessed through the course of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009114 | NIH | None | None |