Youth FORWARD Phase 1 YRI and EPP Study
Condition: Mental Health Disorder; Mental Health Impairment; Psychosocial Impairment; Emotional Dysfunction
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 an Interagency
      Collaborative Team Approach (ICTA) 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 through a pilot study and scale-up intervention study in Sierra Leone.

      Study population: The study population includes youth participants, ages 18-26, with elevated
      t-scores on assessments of functional impairment and emotional dysregulation, who live in the
      Kailhun District of Sierra Leone.

      Pilot study design: A cluster randomized three-arm trial will be employed in the pilot phase
      in the same districts as the scale-up study. Youth participants (N=180, 18-26 years old, 50%
      female), stratified by gender, will be randomized into the three study arms. Once youth
      participants are enrolled into the study, they will be assigned to community level sites
      based on geographical location. Each of these community level sites will make up one cluster.
      The clusters will then be randomly assigned into the three study arms so that sixty youth
      participants will be randomized into the youth entrepreneurship training (EPP) arm, sixty
      youth participants will be randomized into the YRI+EPP arm, and sixty youth participants will
      be randomized into the control arm . The pilot study will last approximately 12 weeks and
      data will be collected at baseline and post-intervention. Further, investigators will survey
      120 third-party reporters for a total pilot study sample size of 300 participants.

      Pilot study primary outcomes: The primary outcomes of the pilot study are to assess
      implementation science aspects related to a new partnership with the Deutsche Gesellschaft
      für Internationale Zusammenarbeit's (GIZ), who will fund and deliver the entrepreneurship
      training. This will include pretesting the measures battery, assessing the logistics of
      integrating the YRI into the entrepreneurship training, and testing use of the Interagency
      Collaborative Team Approach to training, supervision, and fidelity monitoring.
    

Detailed description: 
      Pilot study aims

        1. To examine the psychometric properties of an existing measures battery as well as a new
           battery for third-party reporting,

        2. To assess and adjust as needed structures for training and supervision, including the
           ICTA, and methods for conducting process evaluations of implementation procedures, and;

        3. To assess the feasibility of integrating the YRI into the entrepreneurship training
           (EPP) and using the ICTA to deliver an evidence-informed intervention in Sierra Leone.

      Study design

      The investigators are proposing to conduct a small cluster randomized pilot study with a
      sample of 180 youth participants, aged 18 to 26 years old. Gender within the sample will be
      evenly split with 50% male and 50% female youth participants. GIZ will initiate recruitment
      of and selection of youth participants. An electronic database will only be used by members
      of the research team to contact the youth participants about participating in the research
      study. An additional screening will be completed to ensure candidates meet specific study
      eligibility criteria. Given the socioemotional aims of the YRI, youth participants must
      demonstrate impaired functioning and emotional dysregulation.

      The research team will use the information in the database to contact the EPP-selected
      individuals about participating in our study. Research team members will first attempt to
      reach EPP-selected individuals by telephone, using the telephone numbers provided in the
      database. If an EPP-selected individual is not reachable by telephone, the research team will
      attempt to locate the youth participants at their residence, using the information in the
      database. Because GIZ is a well-known organization in Sierra Leone that has been working in
      the country for many decades and supports a number of employment programs in Kono, Kailahun
      and Koinadugu districts, the investigators do not expect this method of contacting youth to
      cause them any adverse effects.

      During the in-person appointment, the research team member will go through the informed
      consent process for the screening, the potential participant will give consent (or not) and
      the research team member will conduct the mental health screening. After this process, these
      potential participants will be told to wait for follow-up communication from the research
      team. Study investigators have used similar procedures in past studies with success when
      contacting potential study participants.

      After all candidates have been screened, a list of those who meet study criteria will be
      created and youth will be assigned to community level sites based on geographical location.
      Each of these community level sites will make up one cluster. The clusters will be randomized
      into three arms - sixty youth participants will be randomized to receive the EPP only, sixty
      youth participants will be randomized to receive YRI+EPP, and sixty youth participants will
      be randomized into the control group. At least 180 youth participants will be recruited
      assuming 15-20% attrition of subjects, informed by previous work in the region. Given gender
      and cultural norms in Sierra Leone, the YRI+EPP groups will be segregated by sex and these
      groups will be led by same-sex facilitators.

      The pilot will be conducted in Kailhun District, which is one of the districts where GIZ
      operates their employment program. This is also a districts where GIZ has historically
      worked.

      Once the SPs have been on boarded, the in-country leadership team will meet with SP staff to
      discuss the YRI and EPP in-depth and assess interest in being a part of the seed team.
      Selection of the seed team will be followed by a two-week training, which includes the YRI
      and ICTA.

      Although this pilot involves a small sample size and is only powered to detect large
      differences between the intervention groups (YRI+EPP and EPP-only) and control group (no
      treatment), investigators are most interested in assessing the feasibility of integrating the
      YRI into the EPP and using the ICTA to deliver an evidence-informed intervention in a setting
      like Sierra Leone while maintaining intervention quality and improving delivery, as well as
      pretesting the measures battery before the tools are used in the full scale-up study. The
      proposed pilot study design will allow study investigators to examine the psychometric
      properties of measures and do a preliminary assessment on feasibility of program integration
      and seed team functioning and general patterns of improvement whereby investigators expect to
      see greater improvement among youth in the YRI+EPP compared to EPP only.

      Intervention delivery

      Both the YRI and EPP will be delivered over three months. The YRI, which typically assumes a
      three-month delivery period (12 sessions in total, 1 delivered per week), will be delivered
      with two sessions per week allowing for a 1.5-month delivery period during the pilot phase.
      Youth participants will then complete the business skills modules of the EPP, which are
      expected to take another 1.5 months. While the scale-up study allows for the YRI to be
      delivered (0-3 months) followed by the EPP (3-6 months), the pilot approach will condense the
      implementation of the YRI to provide sufficient time to initiate pilot-driven changes and
      obtain Institutional Review Board (IRB) and local approvals before the scale-up is launched.

      YRI facilitators will be selected from staff at the SPs selected by GIZ to deliver the EPP
      training modules. Training and utilization of staff within the ICTA model addresses core
      issues of sustainability within the pilot and larger scale-up study. The in-country
      leadership team will assess agency staff to determine those best suited to deliver the
      YRI+EPP, especially as it concerns this innovative approach to supervision and service
      delivery.

      A sample of YRI facilitators will be selected to form a seed team as part of the ICTA within
      this pilot study. The seed team will work across study sites to engage in routine information
      sharing to promote ongoing intervention fidelity and promote cross-site learning. Those
      chosen to be a part of the seed team will receive training on this approach by in-country
      experts (Dr. Akinsulure-Smith and trained Caritas Freetown research team members) who have
      experience with previous YRI research in Sierra Leone. By incorporating the ICTA into the
      pilot, study investigators will be able to utilize the pilot seed team to train and supervise
      the larger team for the scale-up study.

      Monitoring and evaluation

      Data will be collected pre- and post-intervention by a strong team of in-country experts.
      Innovations for Poverty Action (IPA) will oversee and conduct quantitative data collection
      (youth assessment battery, seed team assessment battery, dissemination and implementation
      measures) and analysis while Caritas Freetown will oversee and conduct qualitative data
      collection as well as the assessment battery for the third-party reporters. IPA is a lead
      institution for designing randomized control and randomized cluster applied research on
      economic and health outcomes in a number of LMICs and has worked with Dr. Betancourt in
      varying capacities in Sierra Leone.

      From previous iterations of the YRI in Sierra Leone, the quantitative assessment battery for
      youth participants underwent a thorough development, translation and validation process. All
      survey tools were subjected to forward and backward translation from English to Sierra
      Leonean Krio utilizing the WHO process of translation and adaptation of instruments, Measures
      have been subjected to cognitive testing to ensure comprehension and cultural relevance in
      assessing mental health, daily functioning, and other life outcomes. However, measures on
      socioeconomic status and economic self-sufficiency did not perform well in the GCC pilot
      study. Study investigators have explored the reasons why and revised the tool used and
      selected new measures, both of which will need to be piloted before being broadly used in the
      scale-up study. Since the impact of the YRI on socioeconomic status and economic
      self-sufficiency of youth participants is one of the aspects of the scale-up study
      investigators will be assessing, it is vital to test these new measures to get a sense of
      appropriateness and performance before including them in the scale-up study. The measures
      utilized in the pilot study will be refined and utilized in the scale-up. IPA frequently
      hires local individuals for short-term data collection assignments. To develop skills and
      capacity and promote consistency, IPA makes an effort to hire the same individuals whenever
      data collection opportunities arise. Thus, over time, these individuals have gained
      experience in data collection and data management and have been trained in all aspects of the
      research process by IPA permanent, experienced, qualified staff. IPA maintains a database of
      these individuals, and this will be used to select the data collection team who will work on
      our pilot and scale-up studies.
    

Intervention name(s): YRI; EPP
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The YRI is designed to assist youth facing complex problems using evidence-based treatments that have been tested and shown to work well in other settings and cultures. The YRI has three specific goals: 1) develop emotion regulation skills for healthy coping; 2) develop problem-solving skills to assist with achieving goals, and; 3) improve interpersonal skills to enable healthy relationships and effective communication. It 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 EPP 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. Our YRI curriculum will be used for the psychosocial competency training module.
Other intervention name(s): Youth Readiness Intervention; Youth Employment Promotion Programme
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A cluster randomized three-arm trial will be employed in the pilot phase in the same districts as the scale-up study. Youth (N=180, 18-26 years old, 50% female), stratified by gender, will be randomized into the three study arms. Once youth are enrolled into the study, they will be assigned to community level sites based on geographical location. Each of these community level sites will make up one cluster. The clusters will then be randomly assigned into the three study arms so that sixty youth will be randomized into the youth employment promotion program (EPP) arm, sixty youth will be randomized into the YRI+EPP arm, and sixty youth will be randomized into the control arm . The pilot study will last approximately 12 weeks and data will be collected at baseline and post-intervention. Further, we will survey 120 third-party reporters for a total pilot study sample size of 300 participants.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment