Youth FORWARD Phase 2 YRI and EPP Study

Mental Health Disorder Clinical Trial

Official title: Youth Functioning and Organizational Success for West African Regional Development: Scale Up

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder
• Mental Health Impairment
• Psychosocial Problem

• NCT number: NCT03542500
• Study type: Interventional
• Source: Boston College
• Status: Completed
• Phase: N/A
• Start date: July 19, 2019
• Completion date: December 31, 2022