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Youth FORWARD Phase 2 YRI and EPP Study

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ClinicalTrials.gov Identifier: NCT03542500
Recruitment Status : Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : July 4, 2018
Sponsor:
Collaborators:
GIZ
Caritas Freetown
University of Georgia
Innovations for Poverty Action
Information provided by (Responsible Party):
Boston College

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 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, ages 18-26, 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, 3-months, and 12-months follow-up.

Scale-up study outcomes:

Primary outcomes of the scale-up study are focused on process and implementation aspects including a costing analysis, measures of fidelity and the sustained delivery of the YRI within a Collaborative Team Approach to intervention delivery, training and supervision. Secondary outcomes are development of emotional regulation skills for healthy coping and assessment of the YRI's ability to improve youth's interpersonal skills and functional impairment.


Condition or disease Intervention/treatment Phase
Mental Health Impairment Mental Health Disorder Psychosocial Problem Behavioral: YRI+Entrepreneurship Training Behavioral: Entrepreneurship Training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Hybrid Type 2 Effectiveness-Implementation Cluster Randomized three-arm trial
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Youth Functioning and Organizational Success for West African Regional Development: Scale Up
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
No Intervention: Control
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.
Experimental: Entrepreneurship Training
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
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. Our YRI curriculum will be used for the psychosocial competency training module.
Other Name: EPP

Experimental: YRI+Entrepreneurship Training
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: YRI+Entrepreneurship Training

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 Entrepreneurship Training includes the following core components: financial literacy and entrepreneurship delivered through six modules (e.g.governance and conflict resolution, psychosocial competencies, entrepreneurship, employability). Our YRI curriculum will be used for the psychosocial competency training module.

In this arm, youth will receive the YRI and then the Entrepreneurship Training


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. Our YRI curriculum will be used for the psychosocial competency training module.
Other Name: EPP




Primary Outcome Measures :
  1. Youth-level outcome measures [ Time Frame: baseline, 3-months and 12-months follow-up ]

    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



Secondary Outcome Measures :
  1. Facilitator-level outcome measures [ Time Frame: 3 months and 12 months ]

    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

  2. Implementation science measures [ Time Frame: baseline and 3 months ]
    • 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

  3. Costing Analysis [ Time Frame: 12 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Youth aged 18-26 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.

Specifically, inclusion criteria for the youth sample is:

  • 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

Inclusion criteria for agencies in this study is:

  • 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.

Inclusion criteria for facilitators in this study is:

  • 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.

Inclusion criteria for third-party reporters in this study is:

  • 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.

Inclusion criteria for agency leaders is:

  • must be a part of one of the agencies selected in GIZ's competitive bidding process and,
  • must hold a leadership position in the agency.

Exclusion Criteria:

Exclusion criteria for the youth:

Youth will be excluded from the study if they do not fulfill the inclusion criteria or:

  • present with severe mental illness (e.g., psychosis), or
  • developmental disability that precludes comprehension of the intervention content and assessments.

Specifically, mental health exclusion criteria are:

  • 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

Exclusion criteria for the agencies:

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.

Exclusion criteria for the facilitators:

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

Exclusion criteria for the third-party reporters:

The third-party reporter will be excluded from the study if:

  • they are under age 18,
  • present with severe mental illness (e.g., psychosis), or
  • developmental disability that precludes comprehension of the intervention content and assessments (as determined by a study social worker), and
  • if the third-party reporter does not have at least monthly contact with the youth participant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542500


Contacts
Contact: Jordan Farrar, Ph.D. 2028349118 farrarjb@bc.edu
Contact: Nathan Hansen, Ph.D. (706) 542-4364 nhansen@uga.edu

Sponsors and Collaborators
Boston College
GIZ
Caritas Freetown
University of Georgia
Innovations for Poverty Action
Investigators
Principal Investigator: Theresa Betancourt, Sc.D., M.A. Boston College

Responsible Party: Boston College
ClinicalTrials.gov Identifier: NCT03542500     History of Changes
Other Study ID Numbers: 18.068.02
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mental Disorders