Healthy Human VolunteersNCT06474260
"One All" to Get it RYT (Resilient Young Tribal Adults)
A study testing "One All" Intervention in people with Healthy Human Volunteers and Youth Resilience, run by University of Pittsburgh at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Human Volunteers, Youth Resilience
- What is being tested?
- "One All" Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesIndia
- Study dates
- 22 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All participants who are tribals and are recruited for One-all intervention
Who cannot join
- All participants who are recruited for One-all intervention, but, are nottribals.
- Any child joining the programme subsequently after the baseline measuresare taken and the first session is delivered will not be recruited.
- If a participant is not fluent in any of the languages listed, they will not beable to participate in the research study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
Institute of Public Health Biligiri Rangana Hills, Chamarajanagar
Chamrajnagar, Karnataka, 571441
Varadharajan Sriniwasan, +919560900978, vardhus@gmail.com
Joseph K U: Sabu, PhD, +917012453006
- Recruiting
Association for the Health Welfare in the Nilgiris
Gudalur, Tamil Nadu, 643212
Varadharajan Srinivasan, +919560900978, vardhus@gmail.com
Smitha Mohanraj, PhD
About this study
Official title: "One All" to Get it RYT (Resilient Young Tribal Adults): A Multi Centric, Participatory,Feasibility and Effectiveness Study
: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:
Read more
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.
Read the 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:
- Connor-Davidson resilience scale (CD- RISC) to measure participant's capacity to bounce back from adversities.
- The Child Youth Resilience Measure (CYRM) - to measure participant's capacity to bounce back from adversities.
- GHQ12, a validated measure of participant's mental well-being.
- Schwarzer's General Self-Efficacy Scale (GSE), to measure participant's 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 Endline.The 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:
- 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.
- Drills: are sporting activities that are more physically involved, but also connected to the application of the learning topic.
- Game: is a mixed-gender "ultimate frisbee" match with modified rules to emphasize the application of the learning topic.
- 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.
- Conditions
- Healthy Human Volunteers, Youth Resilience
- Being tested
- "One All" Intervention
- Keywords
- Tribal Health, Mental health, Implementation Research, Participatory approaches, CFIR, One All, Ultimate Frisbee
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"One All" InterventionBehavioural
One-all is a Three-year curriculum targeted at specific outcomes for each yearfacilitated by young people from the community. The facilitators are inducted througha rigorous facilitators programme of three to five months' length. The facilitators areencouraged to adapt the program to their needs and provide the programme incustomized forms appropriate and as required for the communities. The interventionhas thus far been provided to the fishermen communities in Chennai and anecdotalfield evidence suggest, gains in the intended goals. After these experiences theintervention was being tried amongst the tribal adolescents in Gudalur. One-alltargets to provide the undermentioned skills to achieve the mentioned Goals andSkills:
- self-management • understanding feelings
- social awareness • conflict resolution
- relationship skills • empathy building
- self-awareness Skills •nurturing interpersonal relationships
- identity building • awareness about gender stereotypes
| Study group | Role | What they receive |
|---|---|---|
| A prospective dual site intervention in India | Experimental | The study will utilize a pre-post study design to evaluate the intervention for intendedoutcomes at the end of Year 1. Receives: Behavioral: "One All" Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
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.
Measured: The assessments will be done ar baseline, at 12 months and 18 months.
Resilience meaured by the Child Youth Resilience Measure (CYRM) - a 28 item questionnaires
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.
Measured: The assessments will be done ar baseline, at 12 months and 18 months..
Secondary outcomes (2)
Mental Health as measured by GHQ12
The first secondary outcome is change in Mental health using the GHQ12, a validated measure of psychological well-being. The minimum score is 12 and maximum 36.
Measured: The assessments will be done ar baseline, at 12 months and 18 months.
Mental Health
The second secondary outcome is change in Mental health using the Schwarzer's General Self-Efficacy Scale (GSE), a 10-item validated measure for self-efficacy. The range is 0 to 10.
Measured: The assessments will be done ar baseline, at 12 months and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start22 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Human VolunteersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective dual site intervention in India addressing mental health issues amongyoung adults. The study will consist of three phases. Phase 1 will utilize a case study research design to explore and describe theparticipatory methods used for introduction of "One All". Phase 2 will utilize a mixed methods study design to evaluate facilitator trainingcomponents of "One All" implementation and intervention. Phase 3 will utilize a pre-post study design to evaluate the intervention for intendedoutcomes at the end of Year 1.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Association for Health Welfare in the Nilgiris
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit Nimgaonkar, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474260
- Sponsor's protocol ID
- STUDY23010014
- Other IDs
- 5D43TW009114-10
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "One All" to Get it RYT (Resilient Young Tribal Adults): A Multi Centric, Participatory,Feasibility and Effectiveness Study
- ClinicalTrials.gov ID
- NCT06474260
- Acronym / sponsor ID
- STUDY23010014
- Conditions
- Healthy Human Volunteers, Youth Resilience
- Keywords
- Tribal Health, Mental health, Implementation Research, Participatory approaches, CFIR, One All, Ultimate Frisbee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Association for Health Welfare in the Nilgiris
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: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:
- Connor-Davidson resilience scale (CD- RISC) to measure participant's capacity to bounce back from adversities.
- The Child Youth Resilience Measure (CYRM) - to measure participant's capacity to bounce back from adversities.
- GHQ12, a validated measure of participant's mental well-being.
- Schwarzer's General Self-Efficacy Scale (GSE), to measure participant's 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 Endline.The 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:
- 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.
- Drills: are sporting activities that are more physically involved, but also connected to the application of the learning topic.
- Game: is a mixed-gender "ultimate frisbee" match with modified rules to emphasize the application of the learning topic.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective dual site intervention in India addressing mental health issues amongyoung adults. The study will consist of three phases. Phase 1 will utilize a case study research design to explore and describe theparticipatory methods used for introduction of "One All". Phase 2 will utilize a mixed methods study design to evaluate facilitator trainingcomponents of "One All" implementation and intervention. Phase 3 will utilize a pre-post study design to evaluate the intervention for intendedoutcomes at the end of Year 1.
| Arm | Type | Receives |
|---|---|---|
| A prospective dual site intervention in India | Experimental | Behavioral: "One All" InterventionThe study will utilize a pre-post study design to evaluate the intervention for intendedoutcomes at the end of Year 1. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All participants who are tribals and are recruited for One-all intervention
Key exclusion criteria (3 listed)
- All participants who are recruited for One-all intervention, but, are nottribals.
- Any child joining the programme subsequently after the baseline measuresare taken and the first session is delivered will not be recruited.
- If a participant is not fluent in any of the languages listed, they will not beable to participate in the research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "One All" InterventionOne-all is a Three-year curriculum targeted at specific outcomes for each yearfacilitated by young people from the community. The facilitators are inducted througha rigorous facilitators programme of three to five months' length. The facilitators areencouraged to adapt the program to their needs and provide the programme incustomized forms appropriate and as required for the communities. The interventionhas thus far been provided to the fishermen communities in Chennai and anecdotalfield evidence suggest, gains in the intended goals. After these experiences theintervention was being tried amongst the tribal adolescents in Gudalur. One-alltargets to provide the undermentioned skills to achieve the mentioned Goals andSkills: * self-management • understanding feelings * social awareness • conflict resolution * relationship skills • empathy building * self-awareness Skills •nurturing interpersonal relationships * identity building • awareness about gender stereotypes | Behavioural | A prospective dual site intervention in India |
Primary outcome
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.
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.
2 secondary outcomes
Mental Health as measured by GHQ12
Time frame: The assessments will be done ar baseline, at 12 months and 18 months.
Mental Health
Time frame: The assessments will be done ar baseline, at 12 months and 18 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vishwajit Nimgaonkar, MD, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "One All" Intervention in people with Healthy Human Volunteers and Youth Resilience, run by University of Pittsburgh at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vishwajit Nimgaonkar, MD, PhD (4127265164, vishwajitnl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: The assessments will be done ar baseline, at 12 months and 18 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.