WeRISE: Youth-led Mental Health Transformation Through Cultivating Gratitude, Kindness, and Hope

NCT05944263 | Completed

• 1 other identifier: TWCF0631
• Study Type: interventional
• Target: 840
• Locations: 2 countries
• Sites: 2

Brief Summary

The weRISE study's primary aim is to develop and test the effects of an arts-based train-the-trainer intervention developed to cultivate gratitude, kindness, and hope among youth in schools and informal settlements in both India and Kenya, on mental health and well-being outcomes. The core theory of change for weRISE is that through cultivating these key strengths, youth will undergo empowering mindset shifts that equip them to navigate past, present, and future life challenges, including mental ill-health. Through a cross-country, phased, cluster randomized controlled design, this study will explore the question: what impacts the weRISE intervention has on gratitude, kindness, hope compared with a standard mental health literacy intervention. The investigators will also assess the impacts of weRISE on secondary outcomes such as self-efficacy, the feasibility of the youth-led delivery model, and whether impacts differ depending on setting (schools versus informal settlements, India versus Kenya). The investigators hypothesize that the weRISE intervention will result in greater improvements in mental health and well-being outcomes for youth recipients compared with a standard mental health literacy intervention, and that there will be strong positive relationships between gratitude, kindness, hope, and the mental health and well-being outcomes. The investigators hypothesize that the effects of weRISE will be similar across settings (schools and informal settlements in India and Kenya) and that the youth-led train-the-trainer model will prove effective. Through this project, investigators will work together with leading experts and youth to develop an overall intervention model, contextualize it for India and Kenya respectively, and package a set of implementation tools for weRISE. Importantly, investigators plan to iterate on the content developed and contextualized for India and Kenya and publish a youth-targeted weRISE guide that will provide any young person anywhere with content and concrete activities. The investigators will also develop a series of academic outputs including scientific articles and conference presentations to disseminate evidence and lessons learned. Finally, the investigators will produce and disseminate a policy brief to facilitate uptake and scaling of weRISE by government officials and other decision-makers.

Conditions

Youth Mental Health

Keywords

adolescents; character strengths; cluster Randomized Controlled Trial (cRCT); co-design; arts based mental health intervention; positive psychology

Outcome Measures

Primary Outcomes (2)

• Mental health wellbeing

  Mental health well-being will be measured using Warwick-Edinburgh Mental Wellbeing Scale. The scale measures aspects of positive affect, functioning and interpersonal relationships as components of wellbeing. The scale has 14 items and scores can range from a minimum of 14 to a maximum of 70 points. Higher scores are associated with higher levels of mental well--being.

  Baseline status of the mental health well-being will be assessed before the intervention. Any change in status of mental health well-being when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.

• Character strengths of gratitude, kindness and hope

  Character strengths of gratitude, kindness and hope have been found to be associated with mental wellbeing and will be measured using the Values in Action Questionnaire (VIA) - Youth Version (25-item questionnaire) among adolescents and youth facilitators.

  Baseline status of the character strengths will be assessed before the intervention. Any change in the character strengths when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.

Secondary Outcomes (2)

• Depression

  Baseline status of depression will be assessed before the intervention. Any change in depression when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.

• Anxiety

  Baseline status of anxiety will be assessed before the intervention. Any change in anxiety when compared with the baseline will be assessed within 2 weeks and at 2 months post intervention.

Study Arms (2)

The gratitude, kindness and hope (GKH) program

EXPERIMENTAL

This gratitude, kindness and hope (GKH) program will be a structured manual-based intervention that has been adapted and contextualized from the previous work that has been done in this field. Each intervention session will be conducted in the school and community settings by 2 youth trainers aged 18 - 24 and who will be trained in the delivery of the intervention. The sessions will be held twice a week, concurrently in schools and in the community. Fifty per cent of the sessions will be supervised by master trainers (who are experts in charge of training the youth trainers on the intervention). The rest of the sessions will be audio-recorded and reviewed randomly during supervision meetings. The total duration of each session will be 45 minutes distributed as shown below: iv. 5 minutes warm up activity v. 30 minutes practice and explanation of concepts through interactive activities and discussions vi. 10 mins answering questions and designing homework

Behavioral: weRISE; The gratitude, kindness and hope (GKH) program

The [adapted] Stan Kutcher Teen Mental Health (TMH) program

ACTIVE COMPARATOR

The program delivered to the control group is adapted from the Stan Kutcher Teen Mental Health Curriculum. It was initially developed to help enhance the mental health literacy of students and was developed for ages 13 to 15 years which was further adapted for a slightly lower age group (12-14 yrs) as that targeted in this study through simplification of terminologies to ensure age-appropriate content. Just like the GKH program, the TMH sessions will be delivered by 2 trained youth trainers in the school and community settings. The program will be delivered over 8 sessions, two sessions a week (i.e. over a span of 4 weeks). Half of the sessions will be supervised by master trainers. Like the GKH program, each session will go for 45 minutes each .

Behavioral: The [adapted] Stan Kutcher Teen Mental Health (TMH) program

Interventions

weRISE; The gratitude, kindness and hope (GKH) program BEHAVIORAL

weRISE is an arts based train the trainer intervention that promotes positive mental health through cultivating gratitude, kindness and hope among youth in schools and informal settlements in India and Kenya

The gratitude, kindness and hope (GKH) program

The [adapted] Stan Kutcher Teen Mental Health (TMH) program BEHAVIORAL

The 'Teen Mental Health' curriculum developed by Dr. Stan Kutcher, aims to increase mental health literacy among young people ;will be used in the control group (active comparator group). The control intervention consists of eight sessions (45 minutes each) delivered by older groups of young people (ages 18-24) in schools and community settings through a didactic approach.

The [adapted] Stan Kutcher Teen Mental Health (TMH) program

Eligibility Criteria

• Age: 12 Years - 14 Years
• Gender Eligibility Details: Yes.Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents between the ages of 12-14 will be recruited in the community matching the demographic of the and living within 5 kilometers of the community-based organization will be recruited
• Parents in the community consent and the adolescent's assent to participate in the program at the community-based organization
• Students in grade 7-9 in schools that are demographically similar to the community clusters.
• Participating schools and parents in schools provide consent and the adolescents assent to participate in the program at the schools
• Youth trainers should be between the ages 18-24
• Youth trainers' who consent to participate in the program

You may not qualify if:

• Young people with forms of disabilities (e.g. sight, intellectual) that make it hard for them to meaningfully participate in the programs will be excluded.

Sponsors & Collaborators

• citiesRISE: lead
• Schizophrenia Research Foundation (SCARF India): collaborator
• African Population and Health Research Center: collaborator

Study Sites (2)

Schizophrenia Research Foundation (SCARF India)

Chennai, Tamil Nadu, India

Location

African Population and Health Research Center (APHRC, Nairobi)

Nairobi, Kenya

Location

MeSH Terms

Interventions

Acclimatization

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• Moiteryee Sinha, PhD

  citiesRISE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 13, 2023
• Study Start: July 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 19, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

KE (1); IN (1)