Youth FORWARD Phase 2 YRI and EPP Study
Condition: Mental Health Impairment; Mental Health Disorder; Psychosocial Problem
MeSH terms: Mental Disorders
Study type: Interventional

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.
    

Detailed description: 
      Scale-up Study Objectives

      We propose to implement and test an evidence-based intervention called the Youth Readiness
      Intervention (YRI) alongside GIZ's youth entrepreneurship training (EPP). This scale-up study
      expects to enroll 1200 youth across three treatment arms (control, EPP, YRI+EPP) across GIZ's
      three target districts. Typically, GIZ targets youth considered to be underemployed or
      unemployed and youth with low literacy levels. While that criteria will remain, given the
      socioemotional aims of the YRI, youth must also demonstrate impaired functioning and
      emotional dysregulation as assessed by a screening tool (see section 4b for more information
      regarding inclusion criteria). Together, this model is intended to improve the mental health
      and functioning of vulnerable Sierra Leonean youth while demonstrating the capacity for a
      technical behavioral change intervention to be delivered via an alternative delivery platform
      like employment programs. Past implementation of the YRI in Sierra Leone has led to the
      creation of an evidence-informed intervention that is both relevant and culturally
      responsive. Most importantly, however, the previous implementation of the YRI RCT within
      education relied on trained counselors. By demonstrating that the YRI can be delivered by
      service professionals who may not have clinical training while integrated into employment
      programming the ability for Youth FORWARD to be adopted for scale-up across Sierra Leone and
      other LMICs is further strengthened. Specifically, the objects and aims of this scale up
      study are:

      AIM 1 (Implementation Impact Evaluation): To utilize an innovative Collaborative Team
      Approach (CTA) to scaling and sustaining the YRI in terms of feasibility of this approach,
      facilitator preparedness and sense of satisfaction and impacts on fidelity and sustainment of
      delivery of YRI.

      AIM 2 (Implementation Process Evaluation): To identify internal and external factors
      influencing the integration of the YRI into the youth EPP programs via a process evaluation
      documenting barriers and facilitators to effective implementation and integration.

      AIM 3 (Clinical Effectiveness): To compare clinical effectiveness of YRI when delivered via
      the EPP platform to results of our previous randomized control trial (RCT) of YRI as measured
      by improved mental health and reduced functional impairments among high-risk youth. Emotion
      regulation will be examined as a major mechanism by which the YRI improves behavior of
      treated youth and their functioning in the EPP.

      Subjects

      The total sample size across sites is 3630. The breakdown of study participants by size and
      target population is as follows: 1200 youth participants, 2400 third-party reporters, 20 YRI
      facilitators, and 10 agency stakeholders.

      Study Design and Methods

      The scale-up study reflects a Hybrid Type 2 Effectiveness-Implementation Cluster Randomized
      three-arm trial which simultaneously evaluates the use of a CTA for service delivery,
      supervision, intervention fidelity monitoring, and sustainment of evidence-based practices.
      The study will be conducted in three rural districts in Sierra Leone and involve a total
      sample size across sites of 3630: 1200 youth participants, 2400 third-party reporters, 20
      facilitators, and 10 agency leaders. The 1200 youth (50% females, ages 18-30 years) will be
      randomized into three study arms: 1) control (n=400 youth); 2) EPP-only (n=400 youth); 3)
      YRI+EPP (n=400 youth). Data will be collected at baseline, post-YRI (sub-sample of youth
      randomized to receive the YRI+EPP), post-EPP, and 12-months follow-up.

      Study location The scale-up study will be conducted in the districts of Kono, Koinadugu and
      Kailhun in Sierra Leone, as GIZ's country programming operates exclusively in these
      locations. The most commonly used language in these districts is Krio and all study related
      materials for the field will be translated to Krio.

      Program delivery The YRI is organized into 12, 90-minute group meetings or sessions to be
      delivered over the course of 12 weeks. The YRI is designed to be delivered by a range of lay
      workers in LMICs.

      GIZ will use a competitive bidding process to hire service provision agencies that will
      design and implement the youth EPP training modules. A selection of individuals from the
      agencies will be trained as YRI facilitators.

      Training and supervision Facilitators will receive an intensive training regarding all YRI
      components. This training will be delivered by local experts who have received previous
      training from Youth FORWARD leadership and who have been integral into the creation of the
      YRI

      Data collection IPA will oversee the youth participant quantitative data collection while the
      Caritas Freetown research team will oversee qualitative data collection as well as the
      quantitative data collection regarding the third-party reporters. IPA's local research
      assistants will conduct all screening, baseline, and post-intervention quantitative
      assessments. Youth will be asked to complete the quantitative assessment battery at baseline,
      post-YRI (sub-sample of youth), post-EPP 12-months follow-up (from baseline).

      To strengthen youth self-report and provide more insight into youths' psychosocial
      functioning, we will utilize a third-party reporter to gain further insight into programmatic
      effects. Two third-party reporters will be selected per each youth across all study arms
      (control, EPP and YRI+EPP) from a list provided by the youth participant, and quantitatively
      surveyed at four time points (baseline, post-YRI (sub-sample of youth), post-EPP, and 12
      months). The surveys administered to the third-party reporter include questions related to
      youth participant emotional regulation, workplace performance and interpersonal functioning.

      Study Procedures

      Step 1. Youth who apply and meet the eligibility criteria for the EPP will be contacted by
      our research team. Information about our study will be provided and appointments for
      in-person meetings with research team members will be scheduled.

      Step 2. Consent. Consent forms will be available in Krio. The consent form will be read out
      loud to participants to ensure illiteracy does not interfere with the consenting process.

      Step 3. Once consent is obtained, information for the third-party reporters will be collected
      and youth will be screened to determine if they have elevated t-scores on functional
      impairment based on thresholds from our previous research using questions adapted from the
      World Health Organization Disability Assessment Schedule (WHODAS) (scoring at least a 1 on
      this scale) and have elevated t-scores (62.5 or above) on the Disturbances in Emotion
      Regulation Scale (DERS) as determined through previously validated screening procedures.

      Step 4. Youth who meet our study criteria and are interested in participating will be
      collated into one list. The locations of the residences of these youth will inform our
      clustering approach. Clusters of youth will be assigned to one of the three study arms.

      Step 5. Youth will be contacted and informed of their assigned study arm. The entire
      intervention is expected to last six months with the YRI delivered during the first three
      months and the EPP delivered during the second half of the intervention period.

      Step 6. Youth participants across all treatment arms will be asked to complete quantitative
      assessment batteries at baseline, post-YRI (sub-sample of youth), post-EPP and 12, follow-up.
      The assessment batteries will be used for research purposes. The intervention is delivered
      both for the treatment of the subjects' condition and research purposes.
    

Intervention name(s): Youth Readiness Intervention (YRI); Entrepreneurship Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): EPP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Hybrid Type 2 Effectiveness-Implementation Cluster Randomized three-arm trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment