An interventional study of "One All" Intervention in Healthy Human Volunteers and Youth Resilience, sponsored by University of Pittsburgh. Recruiting at 2 sites in India. Open to participants aged 12 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
: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.
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:
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:
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.
971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.
This study's planned enrollment of 240 is above the median of 116 across 830 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
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.
The study will utilize a pre-post study design to evaluate the intervention for intendedoutcomes at the end of Year 1.
Behavioral: "One All" Intervention
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
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.
Time frame: 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.
Time frame: The assessments will be done ar baseline, at 12 months and 18 months..
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.
Time frame: 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.
Time frame: The assessments will be done ar baseline, at 12 months and 18 months.
Plan to share: Yes — Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap
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