Terminé

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

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Ce qui est testé

EducAid educational programming

+ YRI

+ EducAid educational programming

AutreComportemental
Qui peut participer

Troubles Mentaux+1

+ Troubles de l'humeur

+ Troubles anxieux

De 15 à 24 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude sur les services de santé

Interventionnel
Date de début : avril 2012
Voir le détail du protocole

Résumé

Sponsor principalBoston College
Dernière mise à jour : 31 mai 2018
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 avril 2012

Date à laquelle le premier participant a commencé l'étude.

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.

NCT01684488
Sponsor principalBoston College
Dernière mise à jour : 31 mai 2018
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

443 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Recherche sur les services de santé

Cette étude s'intéresse à la manière dont les soins de santé sont organisés et délivrés, et évalue l'efficacité de différents systèmes ou modèles de prise en charge.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 15 à 24 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles MentauxTroubles de l'humeurTroubles anxieuxTrouble Dépressif

Critères

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.

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

4 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Comparateur actif
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.

Groupe II

Pas d'intervention
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.

Groupe III

Expérimental
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.

Groupe IV

Expérimental
Immediately following enrollment, participants complete the YRI. Participants are then immediately enrolled in EducAid educational programming for the 2012-2013 academic year.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

CARITAS Freetown

Freetown, Sierra LeoneOuvrir CARITAS Freetown dans Google Maps
Terminé1 Centres d'Étude