Violence, Non-accidental Clinical Trial
Official title:
Adapting Mental Health Interventions for War-Affected Youth Through Employment Programs in Sierra Leone
NCT number | NCT02561949 |
Other study ID # | 0603-04 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | October 2017 |
Verified date | May 2018 |
Source | Boston College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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:
1. Participants who are exposed to YRI will demonstrate greater reduction in mental health
and behavioral problems than participants who are waitlisted for YRI over the same
period; emotion regulation will operate as a major mechanism of YRI improvements; high
comorbidity will be a treatment modifier;
2. Improvements in mental health and functioning due to YRI will lead to (mediate) greater
employment outcomes and superior economic self-sufficiency over time; and
3. Homelessness, orphanhood, young parenthood, and high problems in emotion regulation
co-morbid with other mental health conditions will be major moderators lessening the
effectiveness of YRI.
4. Lay and trained practitioners at agencies participating in the combined mental
health-employment program will demonstrate high fidelity to evidence-based treatment
components and that good satisfaction, social support, and professional exchange of
evidence-based practices will emerge.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 24 Years |
Eligibility |
Inclusion Criteria: 1. Participants must be between the ages 15-24 (UN definition of youth); 2. Participants must have an elevated score on internalizing (depression/anxiety) or externalizing (aggression/ hostility) on a measure validated for use in Sierra Leone; 3. Participants must report some impairment in daily functioning as a result of emotional or behavior problems based on a series of questions adapted from the WHODAS; and 4. Participants must neither be enrolled in school nor have gainful employment of 20 or more hours of work per week over the past four weeks. Exclusion Criteria: 1. Participant fails to meet the age requirements; 2. Participant is either currently enrolled in school or has gainful employment of 20 hours or more of work per week over the past four weeks; 3. Participant is not in favor of joining an employment program; 4. Participants does not have an elevated score on internalizing (depression/anxiety) or externalizing (aggression/ hostility) on a measure validated for use in Sierra Leone; 5. Participant does not report some impairment in daily functioning as a result of emotional or behavior problems based on a series of questions adapted from the WHODAS; 6. Participant identified by clinical staff as: (a) experiencing suicidality, or (b) psychosis. 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. |
Country | Name | City | State |
---|---|---|---|
Sierra Leone | CARITAS | Freetown |
Lead Sponsor | Collaborator |
---|---|
Boston College | Caritas Freetown, The City College of New York, World Bank |
Sierra Leone,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 3 months, 6 months, and 12 months | |
Secondary | 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. | 3 months | |
Secondary | 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). | 6 months |
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