Youth FORWARD Phase 2 YRI and EPP Study

NCT03542500 | Completed DMC

• 1 other identifier: 18.068.02
• Study Type: interventional
• Target: 1,783
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (8)

• Costing Analysis

  A costing analysis will be conducted to determine the financial feasibility of the YRI. We will conduct a return on investment (ROI) analysis. The main categories of cost to be quantified are: * Salaries/wages of staff involved in the scale-up study (e.g. salaries of agency staff)-including supplementary benefits, allowances, and employer contributions to local/national taxes or health insurance plans * Facility operating costs associated with running the establishments involved in the scale-up study (e.g. EPP training centers) * Overhead and capital costs relating to the intervention Cost estimates will be obtained from various sources, such as invoices, quotes, employee and contracts. For costs that are difficult to determine with accuracy, we will use estimates by consulting sources to provide effectiveness estimates of the YRI and cost per participant and cost-per-outcome.

  12 months

• Facilitator-level outcome measures

  At the facilitator level we are most interested in assessing one's experience delivering the intervention, including information regarding fidelity, feasibility, and acceptability. These measures include: * Seed Team Assessment Battery, sum scores, higher scores denote higher levels of collaboration and cohesion * Evidence-based Practice Attitudes Scale (adapted) * Levels of Collaboration Scale (adapted) * Team Assessment Questionnaire (adapted) * Perceived Cohesion Scale (adapted) * Facilitator Qualitative Interview Guide

  3 months and 12 months

• Implementation science measures

  * YRI Fidelity Checklist * Dissemination and Implementation Facilitator Survey, higher scores denote higher elements of dissemination and implementation * Dissemination and Implementation Agency Survey, see above for scoring * Dissemination and Implementation Participant Survey, see above for scoring

  baseline and 3 months

• Difficulties in Emotion Regulation

  Changes in youth emotion regulation will be assessed via: • Difficulties in Emotion Regulation (DERS), clinical cut point of 62.5, higher scores denote higher emotion dysregulation

  baseline, 5-weeks, 3-months and 12-months follow-up

• Oxford Measure of Psychosocial Adjustment

  Changes in youth psychosocial adjustment will be assessed via the Oxford Measure of Psychosocial Adjustment which assesses mental health, prosocial attitudes, and functioning. Higher scores on this measure indicate worse psychosocial adjustment.

  baseline, 5-weeks, 3-months and 12-months follow-up

• Hopkins Symptom Checklist

  Changes in youth mental health will be assessed via the Hopkins Symptom Checklist which assesses anxiety and depression. Higher scores on this measure indicate worse mental health.

  baseline, 5-weeks, 3-months and 12-months follow-up

• WHO Disability Assessment Schedule

  Changes in youth functioning will be assessed via: the WHO Disability Assessment Schedule, there is no cut point for this measure but higher scores indicted greater functional impairment.

  baseline, 5-weeks, 3-months and 12-months follow-up

• Economic Self Sufficiency

  Youth economic self sufficiency will be assessed using a template that captures employment across different employment sectors, income generated, and hours worked. This template looks at change over time.

  baseline, 5-weeks, 3-months and 12-months follow-up

Study Arms (3)

Control

NO INTERVENTION

Youth randomized into the control arm of this study will be quantitatively assessed at the same time points as youth randomized into the two treatment arms (baseline, 3-months, 12-months). Due to access to funding and feasibility, youth in the control arm and EPP-only arm will not have the opportunity to receive the YRI once the study period concludes. However, GIZ is conducting a phased roll out of their EPP programming, meaning they will offer their EPP throughout 2018 past their participation in Youth FORWARD. Youth will also be compensated for their participation in our quantitative assessments.

Entrepreneurship Training

EXPERIMENTAL

Youth randomized into the Entrepreneurship Training-only arm will receive GIZ's employment programming approximately three months after the completion of the baseline assessments. The GIZ-supported Entrepreneurship Training program includes six training modules, delivered over three weeks, to include skills development, financial literacy, and other skills necessary to secure employment or engage in livelihood activities.

Behavioral: Entrepreneurship Training

YRI+Entrepreneurship Training

EXPERIMENTAL

Youth randomized into the YRI+Entrepreneurship Training arm will begin the YRI module within two weeks after the completion of baseline assessments. The YRI curriculum (12 modules), will be delivered in 12 weekly 90-minute sessions, with additional time taken as needed. These weekly sessions assume a peer-to-peer group learning format deemed culturally appropriate for a setting like Sierra Leone where limited resources for mental health services exist. Once youth complete the YRI they will complete a post-intervention (3-months) quantitative assessment. Following the completion of the quantitative assessments, youth will receive the Entrepreneurship Training.

Behavioral: Youth Readiness Intervention (YRI); Behavioral: Entrepreneurship Training

Interventions

Youth Readiness Intervention (YRI) BEHAVIORAL

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.

YRI+Entrepreneurship Training

Entrepreneurship Training BEHAVIORAL

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.

Also known as: EPP

Entrepreneurship Training; YRI+Entrepreneurship Training

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Youth aged 18-30 will be included in the Youth FORWARD scale-up study based upon eligibility to the employment program, focusing specifically on socioeconomic status and willingness and interest in participation in an employment program, as well as mental health screening, which will include questions on daily functioning and emotional regulation.
• be Sierra Leonean,
• be female or male aged 18-26,
• be considered a vulnerable youth who is disengaged from both education and employment programs,
• 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)54 and,
• have elevated t-scores (62.5 or above) on the Disturbances in Emotion Regulation Scale (DERS).55
• be a "service provision agency" in Sierra Leone,
• have a minimum of two experts employed, one with subject-specific knowledge and; experience, and another with pedagogical experience in adult education and working with youth with low literacy, and
• sign a Memorandum Of Understanding (MOU) with Boston College (BC) regarding intellectual property of the YRI.
• be employed by one of the agencies selected in GIZ's competitive bidding process, and
• agree to participation in the ICTA which utilizes an enhanced supervision structure throughout the intervention.
• be over age 18,
• be nominated by the youth participant,
• provide oral consent to participate in the quantitative assessments, and
• have daily to weekly contact with the youth participant throughout the duration of this scale-up study, which will be assess via verbal confirmation when obtaining oral consent.

You may not qualify if:

• present with severe mental illness (e.g., psychosis), or
• developmental disability that precludes comprehension of the intervention content and assessments.
• severe, active suicidality or psychosis as assessed via the MINI-KID diagnostic assessment administered by a study social worker and,
• serious cognitive impairments that might preclude one's ability to comprehend informed consent and complete study assessments as determined by a study social worker.
• Youth who report active suicidality or symptoms of psychosis requiring more intensive mental health care will be referred for immediate individual mental health services
• Agencies will be excluded from participation if:
• they are not considered a "service provision agency", and
• if they do not have a minimum of two experts employed: one with subject-specific knowledge and experience, and another with pedagogical experience in adult education and working with youth with low literacy.
• Those holding leadership positions within the agencies selected to deliver the intervention will be excluded from participation in the qualitative interviews if:
• they are not employed at the agencies selected, or
• are not considered to be in a leadership position within the agency.
• Facilitators will be excluded from participation in delivering the intervention if:
• they are unable to deliver core components of the YRI and EPP intervention, and
• if they are unable to meet the logistical demands of the ICTA
• The third-party reporter will be excluded from the study if:

Sponsors & Collaborators

• Boston College: lead
• German Society for International Cooperation: collaborator
• Caritas Freetown: collaborator
• University of Georgia: collaborator
• Innovations for Poverty Action: collaborator

Study Sites (3)

Kailahun District

Kailahun, Sierra Leone

Location

Koinadugu District

Koinadugu, Sierra Leone

Location

Kono District

Kono, Sierra Leone

Location

Related Publications (4)

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

  PMID: 22310560 BACKGROUND

• Freeman JA, Farrar JC, Placencio-Castro M, Desrosiers A, Brennan RT, Hansen NB, Akinsulure-Smith AM, Su S, Bangura J, Betancourt TS. Integrating Youth Readiness Intervention and Entrepreneurship in Sierra Leone: A Hybrid Type II Cluster Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2024 Jul;63(7):708-719. doi: 10.1016/j.jaac.2023.09.552. Epub 2023 Dec 22.

  PMID: 38143022 DERIVED

• Bond L, Farrar J, Borg RC, Keegan K, Journeay K, Hansen N, Mac-Boima E, Rassin A, Betancourt TS. Alternate delivery platforms and implementation models for bringing evidence-based behavioral interventions to scale for youth facing adversity: a case study in West Africa. Implement Sci Commun. 2022 Feb 16;3(1):16. doi: 10.1186/s43058-022-00259-5.

  PMID: 35168661 DERIVED

• Betancourt TS, Hansen N, Farrar J, Borg RC, Callands T, Desrosiers A, Antonaccio CM, Williams MJ, Bangura J, Brennan RT. Youth Functioning and Organizational Success for West African Regional Development (Youth FORWARD): Study Protocol. Psychiatr Serv. 2021 May 1;72(5):563-570. doi: 10.1176/appi.ps.202000009. Epub 2020 Dec 9.

  PMID: 33291974 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Theresa Betancourt, Sc.D., M.A.

  Boston College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Under the supervision of Innovations for Poverty Action (IPA) Sierra Leone, local research assistants (blind to site and youth condition assignments) will conduct all screening, baseline, and follow up quantitative assessments. Ongoing data collection at all sites will include youth attendance and satisfaction with YRI content, counselor satisfaction with content and delivery via scales and qualitative exit interviews, as well as monitored audio-recording of all sessions for fidelity by an independent expert rater hired by CARITAS. The expert fidelity monitor will be a skilled YRI trainer and supervisor from our prior RCT and will not be a part of the CTA Seed Team, thus allowing them to provide impartial and blinded fidelity ratings of all audio-transcripts.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type 2 Effectiveness-Implementation Cluster Randomized three-arm trial

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: May 31, 2018
• Study Start: July 19, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SI (3)