An interventional study of YRI and Income generating activity program in Anxiety Disorder/Anxiety State, Depressive Disorder/Psychology and Social Problems/Psychology, sponsored by Boston College. Completed at 1 site in Sierra Leone. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by Boston College · Not applicable, Interventional, and Health services research
The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial functioning outcomes in youth aged 15 - 24. The research also intends to examine whether youth participating in YRI and complementary income generating activities will fare better than an employment only control group. Finally, the research intends to examine whether utilizing lay health workers are a is cost-effective and scalable method for addressing mental health concerns.
The research will investigate the following hypotheses:
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.
This exploratory randomized control study of youth aged 15-24 comparing outcomes among youth participating in YRI proceeding enrollment in an income generating activity program (YRI + EP) to a control group that participates only in income generating activity programs (EP). This study is not fully powered to detect differences between groups and is instead a test of the intervention feasibility and acceptability, with quantitative participant assessments occurring at baseline, 3-months, 6-months, and 12-months with respect to employment related measures, and participant and interventionists interviews to elucidate mechanisms by which the intervention was more or less successful.
The YRI is an evidence-based group intervention developed in 2010 to address key emotional, behavioral, and functioning difficulties identified by the PI's prior longitudinal study of war-affected youth. The YRI has three overarching goals: (1) To improve interpersonal and community relationships through work with youth and community members; (2) To help vulnerable youth develop skills in emotional regulation, problem-solving, and interpersonal interactions necessary to be successful members of their communities; (3) To promote the healthy integration of difficult memories for youth who experience difficulties due to traumatic exposure. 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. During this study YRI will be delivered by trained counselors,
Income generating activity programming will be carried out by GOAL and their partner St. George's Foundation through use of their current grant funding. GOAL focuses on supporting people in need by providing healthcare resources, advocating and advancing child protection practices and policies, and administering livelihood programs to empower them improve their lives in a sustainable manner. The St. George's Foundation's addresses child welfare concerns by actively reaching out to homeless and orphaned children. Their already existing employment program is 4 months in length and consists of skills training, soft skills development (primarily in numeracy and literacy), and a cash transfer of $200. The employment intervention is carried out by social workers and counselors, who have been trained to support delivery of the intervention.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Boston College is the lead sponsor of 38 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Participants at risk of harm to themselves or others, as well as those requiring treatment beyond the scope of YRI will be referred to local mental health or social work treatment facilitates as appropriate.
Immediately following enrollment participants will complete the YRI intervention, followed by an income generating activity program.
Behavioral: YRI · Other: Income generating activity program
Immediately following enrollment participants will complete an income generating activity program.
Other: Income generating activity program
Youth Readiness Intervention (YRI) is an innovative, evidence-based mental health intervention to address co-morbid difficulties with externalizing problems (anger/emotion dysregulation) and internalizing problems (hopelessness/anxiety) among violence-affected youth. YRI methodology draws on evidence-based treatment elements commonly used in both cognitive-behavioral intervention and group interpersonal therapy. YRI has cross-cutting efficacy across a range of mental health conditions common in violence-affected youth. YRI will be delivered in 12 sessions over the course of 3 months.
Also known as: Youth Readiness Intervention
Income generating activity programming will be carried out by GOAL in partnership with St. George's foundation through use of their current funding. GOAL focuses on supporting people in need by providing healthcare resources, advocating and advancing child protection practices and policies, and administering livelihood programs to empower them improve their lives in a sustainable manner. The St. George's Foundation's addresses child welfare concerns by actively reaching out to homeless and orphaned children. The program is 4 months in length and consists of skills training, soft skills development (primarily in numeracy and literacy), and a cash transfer of $200.
Change in % of youth with improved health outcomes
The percent of youth with improved mental health and daily functioning will be measured through a quantitative assessment battery including measurements from the Hopkins Symptoms Checklist, Oxford Measure of Psychosocial Adjustment, Ways of Coping Questionnaire, UCLA Traumatic Stress Disorder Reaction Index, World Health Organization Disability Adjustment Scale, Difficulties in Emotion Regulation Scale.
Time frame: Baseline, 3 months, 6 months, and 12 months
YRI Fidelity Protocol
Feedback will be gained on the more or less successful programmatic mechanisms and the intervention quality and sustainability through semi-structured qualitative exit interviews with interventionists and youth.
Time frame: 3 months
Change in knowledge, attitudes, and behaviors of youth around employment and access to employment services.
Supervisors will assess youth on attendance, workplace performance, economic self-sufficiency, financial consumption/expenditures, savings and employment-related behaviors (supervisors will be interviewed about each young person blind to their group assignment).
Time frame: 6 months
Ran from Sep 2015 to primary completion in Aug 2017, 23 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 23 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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