Clinical trial NCT05944263: WeRISE: Youth-led Mental Health Transformation Through Cultivating Gratitude, Kindness, and Hope
Official title: Effectiveness of an Intervention on Cultivating Character Values of Gratitude, Kindness and Hope to Enhance Mental Well-Being Among Young People in School and Community Settings in India and Nairobi: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Youth Mental Health
Keywords: adolescents
character strengths
cluster Randomized Controlled Trial (cRCT)
co-design
arts based mental health intervention
positive psychology
Lead sponsor: citiesRISE
Sponsor class: OTHER
Collaborators: name: Schizophrenia Research Foundation (SCARF India)
name: African Population and Health Research Center
First posted: 2023-07-13
Enrollment: 840
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The adolescent years for young people is a period of crucial life transitions and is fraught with a range of internal and external challenges. Young people in low- and middle-income countries (LMICs) are particularly vulnerable to mental ill health given the exposure to multiple adverse life experiences. Positive psychological interventions have been brought into the social-emotional learning curriculum of western countries and has shown efficacy in supporting the salutary effects of the same in the health and wellbeing of the young people. In most LMICs, where there is less access to psychologists and psychiatrists, the models that are used have only a limited amount of application to the young people who are struggling.

The primary goal of this project is to design and test the effects on mental health and well-being outcomes of an arts-based train-the-trainer intervention, cultivating gratitude, kindness, and hope among youth in schools and informal settlements. The central change theory is that by cultivating these key strengths, youth will experience empowering mind-set shifts that will prepare them to navigate past, present, and future life challenges, including mental illness.

In order to create a robustly tested, adaptable, and scalable intervention that speaks directly to the realities of young people in schools and informal settlements in LMICs, this project will integrate the research currently available in the fields of character development, positive psychology, and mental health. This project will support cross-border collaboration in a number of ways to successfully bridge these rich and diverse sectors. It will bring together specialists from LMICs and high-income countries (HICs), mental health and character development professionals, as well as youth and adult researchers, to produce the fundamental evidence at the nexus of character development and health outcomes.

This project will use a single-blind cluster randomized controlled trial design with 10 clusters 60 young people within schools and 30 in communities recruited from informal settlements in Nairobi and India. The evaluation will employ a mixed methods approach to determine the impact of the intervention on mental wellbeing of young people. Quantitative data will be collected through a survey at baseline and end-line while focus group discussions (FGD) will only be conducted at end-line. These will be analyzed using STATA and NVivo softwares respectively.

This project proposes that, the model and evidence generated will be innovative in a number of ways: 1) it is designed to scale in low-resource settings and takes replicability into account from the start. 2) the intervention's accessibility to a diverse range of youth in LMICs, including the most marginalized, is considered from the start; 3) it departs from the traditional approach of testing interventions based on individual character strengths in order to weave gratitude, kindness, and hope together through an integrated life course (past, present, and future) approach and; 4) the focus is on young people's leadership and their ability to support themselves and their peers. Character strengthening is associated with independent critical thinking inherently required in developing leaders. While this is not an outcome of the study the ability to lead oneself and others with compassion signifies likelihood of a longer-term impact of the character strengthening intervention. Findings from the study would contribute towards improving mental health policies and programs.

Eligibility criteria: Inclusion criteria for adolescents in community clusters

* 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

Inclusion criteria for adolescents in school clusters

* 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

Inclusion criteria for youth trainers

* Youth trainers should be between the ages 18-24
* Youth trainers' who consent to participate in the program

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mental health wellbeing
timeFrame: 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.
measure: Character strengths of gratitude, kindness and hope
timeFrame: 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:
measure: Depression
timeFrame: 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.
measure: Anxiety
timeFrame: 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.
Other outcomes:
Locations:
city: Chennai
country: India
facility: Schizophrenia Research Foundation (SCARF India)
state: Tamil Nadu
city: Nairobi
country: Kenya
facility: African Population and Health Research Center (APHRC, Nairobi)
Study officials:
affiliation: citiesRISE
name: Moiteryee Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: