Depressive Disorder Clinical Trial
Official title:
A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone
This research is a continuation of the Youth Readiness Intervention (YRI) randomized clinical
trial by adding additional pre and post intervention data collection upon treatment of the
control group (N=222) with the intervention which was proven effective in the larger trial.
The overall research has investigated whether participation in the YRI intervention will
improve emotional regulation, prosocial attitudes/behavior, social support and daily and
functioning among war-affected 15-24 year olds in Sierra Leone. In this sub-study which will
involve treatment of the control group with the effective YRI intervention, the investigators
will add an additional measure of self-regulation as observed via DNA methylation in buccal
cells collected via cheek swabs. As before, after the YRI intervention, youth will be offered
a free educational opportunity at the EducAid program in Freetown or in one of its
upline/provincial sites. This stage of the research, as in the treatment with the main group,
will test whether youth enrolled in the YRI psychosocial intervention go on to demonstrate
improved attendance and behavior in a subsidized education program. In the previous phase of
the trial, the investigators did observe significant effects for the YRI intervention and
evidence that the program is indeed effective. For instance, post-intervention, YRI youth
reported greater improvements in emotion regulation (β=0.109, 95%CI 0.026 to 0.191, δ=0.31),
prosocial attitudes/behaviors (β=0.149, 95%CI 0.057 to 0.240, δ=0.38), and social support
(β=0.119, 95%CI 0.009 to 0.229, δ=0.26) than controls, and greater reductions in functional
impairments (β= -0.175, 95%CI -0.299 to -0.050, δ= -0.35). Differences in symptoms were
non-significant at six-month follow-up for the full sample; moderator analyses showed that,
for individuals in the top quartile of baseline symptoms, YRI youth had greater improvements
in emotion regulation and social support than controls. At eight-month follow-up, teachers
reported that YRI participants were 8.9 times more likely to be in school (28.8% v. 4.7%) and
showed better attendance (β=3.553, 95%CI 0.989 to 6.118, OR=34.93) and academic performance
(β= -0.954, 95%CI -1.807 to -0.102, δ= -1.31).
In this final phase of the trial as the investigators treat the wait list control group, the
investigators will test whether intervention effects observed in self-report data on improved
emotion-regulation are also upheld in biomarker data. Thus, the investigators will now
provide YRI treatment to the wait list control group and employ the use of biomarkers as a
measure of the intervention's effectiveness. The objective of the study will be to assess
whether DNA methylation (collected via cheek swabs of buccal cells) is associated with
changes in emotion regulation pre- and post- intervention. The aim is to test the hypothesis
that the YRI is associated with improvements emotion-regulation evidence both in self-report
data on emotion-regulation and in buccal cell DNA methylation. This study will add to the
evidence base for effective, culturally sensitive mental health services for youth and young
adults affected by war and other forms of adversity.
In Sierra Leone, a dangerous gap remains between long-term psychosocial needs and adequate
services. As youth affected by the war begin to enter adulthood, they face new challenges
including unemployment, interrupted education, the need to support families, marginalization
and stigma, as well as the remaining psychological effects of exposure to war. Healthy social
integration is critical to the long-term wellbeing of this generation, but the evidence base
on effective interventions to improve skills and self-efficacy is severely limited. Despite
the high burden of mental health problems among war-affected youth in Sub-Saharan Africa, few
empirically-supported behavioral treatments (ESBTs) or evidence-based interventions have been
implemented in this region. This study stands to make an important contribution to knowledge
on effective and culturally-sensitive mental health services that can be implemented in
settings fraught by multiple hardships, including war, poverty, low educational attainment,
and other hardships.
The Research Program on Children and Global Adversity at the Harvard School of Public Health
has implemented the Youth Readiness Intervention (YRI) to address some of the challenges that
youth face, including lack of education and employment, stigma and marginalization, and the
long-term psychological effects of exposure to war. The YRI is an evidence-based group
intervention designed to improve emotion regulation/reduce anger and foster prosocial
functioning among 15-24 year old war-affected youth. It is grounded in findings from
Betancourt et al.'s three wave-longitudinal study carried out from 2002 to 2008, which
provides insight into how the adjustment of youth in post-conflict Sierra Leone is shaped by
violence exposure and post -conflict loss and life disruption including family
reconfiguration.
The intervention has three main goals: (1) Develop emotion regulation skills for healthy
coping; (2) Develop problem solving skills to assist with achieving goals; (3) Improve
interpersonal skills to enable healthy relationships and effective communication. Primary
mental health outcomes include decreased anxiety, hostility, and depression, and increased
pro-social attitudes, as measured by the Oxford Refugee Studies Psychosocial Adjustment Scale
and the African Youth Psychosocial Assessment.
The addition of biomarkers research will build on a rare randomized controlled trial
conducted in 2012-2014, where the control group will now receive the treatment and will be
randomized in a lagged design to YRI or control and then all participants treated with the
YRI. Therefore, the research data collection of the biomarkers will have three overarching
aims: 1) To develop feasible and acceptable methods for collecting and analyzing genetic and
epigenetic biomarkers from war-exposed youth in Sierra Leone. This will include forging
collaborations with expert colleagues engaged in biomarker research, development of ethical
protocols for data collection/storage, and review of the literature on genetic variation and
mechanisms related to psychopathology. 2) To obtain biosamples from the control study
participants of the randomized controlled YRI trial (2012-2014) and investigate the
possibility of using this research methodology as a component of a fourth wave of data
collection among war-affected youth and their families. 3) To investigate improvements in
epigenetic marks (DNA methylation) pre- and post- the Youth Readiness Intervention and its
associations with the findings from participants' self-reports on emotion regulation and
prosocial functioning.
EducAid is a charitable trust established in 1994. Devoted to promoting education among
underprivileged and war-affected young people in Sierra Leone through holistic and academic
learning, EducAid provides free year-round education to over 1,500 youth, along with food,
medicine, and shelter when needed. EducAid has a keen interest in exploring how psychosocial
interventions can promote academic, social, and emotional well-being in students. EducAid's
education model aims to improve academic knowledge, self-efficacy, and attitudes toward
school. Additionally, it aims to nurture hope for the future and a sense of normalcy through
interactions with teachers, mentors, and peers. Following participation in the education
component, participants' employment and economic activity will be assessed using standardized
instruments for cross-cultural work, including the World Bank Living Standards Surveys.
The Douglas Institute's Research Centre is the oldest centre of its kind in Quebec. With an
annual budget of $18.5 million USD, it brings together over 300 distinguished researchers and
post-doctoral fellows from all over the world, whose breakthroughs produce some 215
scientific publications every year. Recognized as a flagship centre by the Fonds de la
recherche en santé du Québec (FRSQ), the provincial health research fund, the Research
Centre, overseen by a board of directors, is financed in part by the Douglas Institute
Foundation and in part by Canada's most prestigious research grants, including Canadian
Institutes of Health Research (CIHR) and FRSQ, to name just two. It also sets itself apart
with innovative research projects in the neurosciences, clinical and psychosocial divisions.
In addition, the World Health Organization (WHO) Collaborating Centre in Montreal chose the
Institute to establish its Centre for Research and Training in Mental Health.
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