Trial of the Youth Readiness Intervention

Study Overview
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Brief Summary
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The research will first examine data obtained from YRI participants to investigate effects of the group sessions on psychosocial and functioning outcomes in youth. In pursuit of this aim, this research will investigate the following hypothesis: Participation in the Youth Readiness Intervention will reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds in Sierra Leone. The research also intends to examine whether youth enrolled in a psychosocial Youth Readiness Intervention (YRI) and a complementary education program fare better than an education-only control group, a psychosocial-only control group, and a waitlist control group. In pursuit of this second aim, this research will investigate the following hypothesis: A combined psychosocial-education program is an effective paradigm for improving psychosocial, functional, educational, and economic self-sufficiency outcomes among war-affected youth.

Detailed Description
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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 randomized study of 416 school-intending youth age 15-24 will use a parallel design to examine the potential benefits of enrolling in a psychosocial intervention--the YRI--prior to enrolling in an educational program. Assessments will be performed pre-/post-intervention and at 6-month and 12-month follow-ups. These long-term evaluations will examine whether benefits are sustained, accrue, or depreciate over time. Data will improve understanding of how a psychosocial-education intervention translates to economic outcomes like employment, as compared to an education-only intervention. 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. It is designed to reduce symptoms of internalizing, externalizing, trauma-related symptoms, and improve prosocial skills and functioning among war-affected 15-24 year olds. 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. 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.

Official Title
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A Feasibility Trial of the Youth Readiness Intervention: A Group Psychosocial Intervention for War-affected Youth in Sierra Leone

Conditions
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Anxiety Disorder/Anxiety State, Depressive Disorder/Psychology, Social Problems/Psychology, Stress, Psychological, Violence, Non-accidental

Intervention / Treatment
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* Behavioral: YRI
* Other: EducAid educational programming


Participation Criteria
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Eligibility Criteria
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Once youth are referred to the study, a screening tool will be administered to determine whether or not they meet eligibility requirements as described below. The screening tool contains four sections; Consent and Age: assures that participants meet the age requirements Oxford Refugees Psychosocial Adjustment Scale: assesses depression, anxiety and hostility Functioning: assesses the participant's ability to carry out activities of daily living Psychological Analysis: clinician's assessment of the psychological state of the participant. Inclusion Criteria: Participants must be between 15-24 years of age; Participants must prefer to have the opportunity to join an educational program but not currently be enrolled in school; A participant's total score on the Oxford scale must equal or exceed 30 AND Participants must display at least one non-zero score on the functioning questions. Exclusion Criteria: Participant does not plan to reside in the Freetown urban area for the duration of the study (9 months from start date); Participant fails to meet age requirements; Participant is currently enrolled in school; Participant is not in favor of joining an educational program; Participant fails to meet Oxford psychosocial or functioning thresholds; Participant is judged by clinical staff as: Needing mental health treatment beyond the scope of the YRI Otherwise not suitable for a group treatment setting Participant displays the following: Cognitive delays Active suicidality Psychosis Risk of harm to themselves or others Participants at risk of harm to themselves or others, as well as those requiring treatment beyond the scope of the YRI, will be referred to local mental health or social work treatment facilities as appropriate.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Waitlist+EducAid<br>Immediately following enrollment, participants do not immediately receive any intervention. At 3 months, they are enrolled in EducAid educational programming for the 2012-2013 academic year. | Other: EducAid educational programming<br>* EducAid is a charitable trust that provides free year-round education to over 1,500 youth, along with food, medicine, and shelter when needed. 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.<br>|
| No Intervention: Waitlist<br>Participants do not receive any intervention throughout the trial period. Once the trial has concluded, participants are invited to enroll in EducAid educational programming for the 2013-2014 academic year. | |
| Experimental: YRI only<br>Immediately following enrollment, participants complete the YRI. They are then placed on a waitlist for the remainder of the trial. At the end of the trial, participants are invited to enroll in EducAid educational programming for the 2013-2014 academic year. | Behavioral: YRI<br>* The YRI brings together six empirically-supported practice elements shown to be efficacious across different mental health interventions, as well as methods intended to socialize youth and improve self-efficacy. Practice elements address the broad scope of problems evidenced in Sierra Leonean war-affected youth and enhance the YRI's pacing, which progresses through three phases traditionally used in trauma treatments (stabilization, integration, connection). The weekly intervention takes place over 10 sessions lasting approximately one hour and a half. Groups are divided by gender and age. Each group is paired with two interventionists of the same gender.<br>* Other names: Youth Readiness Intervention;Other: EducAid educational programming<br>* EducAid is a charitable trust that provides free year-round education to over 1,500 youth, along with food, medicine, and shelter when needed. 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.<br>|
| Experimental: YRI+EducAid<br>Immediately following enrollment, participants complete the YRI. Participants are then immediately enrolled in EducAid educational programming for the 2012-2013 academic year. | Behavioral: YRI<br>* The YRI brings together six empirically-supported practice elements shown to be efficacious across different mental health interventions, as well as methods intended to socialize youth and improve self-efficacy. Practice elements address the broad scope of problems evidenced in Sierra Leonean war-affected youth and enhance the YRI's pacing, which progresses through three phases traditionally used in trauma treatments (stabilization, integration, connection). The weekly intervention takes place over 10 sessions lasting approximately one hour and a half. Groups are divided by gender and age. Each group is paired with two interventionists of the same gender.<br>* Other names: Youth Readiness Intervention;Other: EducAid educational programming<br>* EducAid is a charitable trust that provides free year-round education to over 1,500 youth, along with food, medicine, and shelter when needed. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) | Primary outcomes of interest include changes in depression, anxiety, hostility, confidence, and pro-social behaviors. These constructs will be measured by the Oxford Refugee Studies Psychosocial Adjustment Scale. An additional primary outcome, daily functioning, will be assessed by the World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0). Both measures are incorporated within the study's comprehensive Youth Assessment Battery. | Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on the Youth Assessment Battery | Secondary outcomes include the participant's interpersonal and community relations, experience of daily hardships, coping skills, post-traumatic stress, emotion regulation, health, risk behaviors, and other constructs as they relate to the YRI intervention areas. | Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression/therapy;, Developing Countries;, Interpersonal Relations;, Life Change Events;, Psychotherapy, Group;, Resilience, Psychological;, Sierra Leone;, Survivors/psychology;, Social Adjustment;, Social Behavior;, War