"One All" to Get it RYT (Resilient Young Tribal Adults)

NCT06474260 | Recruiting

• 2 other identifiers: STUDY230100145D43TW009114-10
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Human Volunteers; Youth Resilience

Keywords

Tribal Health; Mental health; Implementation Research; Participatory approaches; CFIR; One All; Ultimate Frisbee

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  The assessments will be done ar baseline, at 12 months and 18 months..

Secondary Outcomes (2)

• Mental Health as measured by GHQ12

  The assessments will be done ar baseline, at 12 months and 18 months.

• Mental Health

  The assessments will be done ar baseline, at 12 months and 18 months.

Study Arms (1)

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.

Behavioral: "One All" Intervention

Interventions

"One All" Intervention BEHAVIORAL

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

A prospective dual site intervention in India

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All participants who are tribals and are recruited for One-all intervention

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Association for Health Welfare in the Nilgiris: collaborator

Study Sites (2)

Institute of Public Health Biligiri Rangana Hills, Chamarajanagar

Chamrajnagar, Karnataka, 571441, India

RECRUITING

Association for the Health Welfare in the Nilgiris

Gudalur, Tamil Nadu, 643212, India

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Vishwajit Nimgaonkar, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishwajit Nimgaonkar, MD, PhD

CONTACT

4127265164; vishwajitnl@upmc.edu

Triptish Bhatia, PhD

CONTACT

9910107210; trb16@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: April 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of this study.
• Access Criteria: For individual participant data, meta-analysis.

Locations

IN (2)