Youth FORWARD Phase 2 YRI and EPP Study

Summary

Objectives:

The objectives of this research proposal are to study the delivery of an evidence-based mental health intervention in the alternate setting of youth employment programs tied to regional economic development and to examine the use of a Collaborative Team Approach (CTA) as an implementation scale-up strategy that addresses the human resource shortage and related access to care and capacity challenges in low- and middle-income countries (LMICs). Specifically, this study aims to examine the incorporation of the evidence-based Youth Readiness Intervention (YRI) into a program that promotes employment among youth (EPP/Entrepreneurship Training program) through a pilot study and scale-up intervention study in Sierra Leone.

Study population:

The study population includes youth, ages 18-30, with elevated t-scores on assessments of functional impairment and emotional dysregulation, who live in the Kono, Koinadugu and Kailhun districts of Sierra Leone.

Scale-up study design:

For the scale-up study, a Hybrid Type 2 Effectiveness-Implementation Cluster Randomized Three-arm trial will be employed. We estimate the entire sample size for the scale-up study to be 3,630 participants, including 1200 youth, 10 agency heads, 20 intervention facilitators, and 2400 third-party informants. Upon enrollment into the study, youth will be assigned to community level sites based on geographical location. Each of these community level sites will make up one cluster. These clusters will be randomized into the three study conditions: the control condition - where youth do not receive the YRI or the EPP but are able to utilize as available resources in the community - the EPP-only condition, and the YRI+EPP condition. Data will be collected at baseline, post-YRI, post-EPP, and 12-months follow-up.

Scale-up study outcomes:

Implementation outcomes of the Hybrid Type II study are focused on process and implementation aspects including a costing analysis, measures of fidelity and the sustainment and quality of delivering YRI within a Collaborative Team Approach to support intervention delivery, training and supervision. Effectiveness outcomes of the Hybrid Type II study are development of emotion regulation, mental health assessed as anxiety and depression, and interpersonal functioning, including self report and by third-party reporters for assessment of the YRI's ability to improve youth's interpersonal skills and functioning in the community and the entrepreneurship training program. In a Hybrid Type II study implementation and effectiveness aims are dual and equally important aspects of the study. (Curran et al., 2015) Outcomes associated with both aims are considered primary outcomes in this study.

Conditions

• Mental Health Impairment
• Mental Health Disorder
• Psychosocial Problem

Interventions

BEHAVIORAL

Youth Readiness Intervention (YRI)

The Youth Readiness Intervention integrates six CBT-based, empirically-supported practice elements shown to have transdiagnostic efficacy across disorders ranging from major depressive disorder to PTSD and conduct disorders. The YRI's six evidence-based components are delivered in three phases common in trauma-informed interventions: stabilization, integration, and connection.

BEHAVIORAL

Entrepreneurship Training

The youth capacity development component of GIZ's Entrepreneurship Training includes the following core components: financial literacy, entrepreneurship, and vocational training delivered through six modules (agro-processing, solar photovoltaic installation and maintenance, governance and conflict resolution, psychosocial competencies, entrepreneurship, employability). Youth will be trained at training sites and have access to a youth center in the area. These centers will have agricultural equipment and machinery available for youth to use.

Sponsors & Collaborators

• German Society for International Cooperation

  collaborator OTHER

• Caritas Freetown

  collaborator OTHER

• University of Georgia

  collaborator OTHER

• Innovations for Poverty Action

  collaborator OTHER

• Boston College

  lead OTHER

Principal Investigators

• Theresa Betancourt, Sc.D., M.A. · Boston College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-19

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Sierra Leone

Study Locations