Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05944263 |
| Other study ID # |
TWCF0631 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
July 2023 |
| Source |
citiesRISE |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
