Youth FORWARD Phase 1 YRI and EPP Study

NCT03603613 | Completed DMC

• 1 other identifier: 18.068.01
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Mental Health Disorder; Mental Health Impairment; Psychosocial Impairment; Emotional Dysfunction

Outcome Measures

Primary Outcomes (1)

• Youth-level outcome measures: emotion regulation

  Change in youth mental emotion regulation will be assessed via the following measure: • Difficulties in Emotion Regulation (DERS), clinical threshold for emotion dysregulation set at a score of 62.5, range of scores is from 36-180, higher scores denote higher levels of emotion dysregulation

  baseline and 3-months (post-intervention)

Secondary Outcomes (1)

• Youth-level outcome measure: youth employment and economic self-sufficiency

  baseline and 3-months (post-intervention)

Study Arms (3)

EPP: Entrepreneurship Programme

EXPERIMENTAL

EPP: Entrepreneurship Programme: Youth randomized into the EPP-only arm will receive GIZ's employment programming within two weeks after the completion of the baseline assessments. The GIZ-supported EPP program includes six training modules. The modules include skills related to entrepreneurship, financial literacy, and skills building.

Behavioral: EPP

EPP+YRI

EXPERIMENTAL

EPP+YRI: Youth randomized into the EPP+YRI arm will begin the Entrepreneurship programme within two weeks of baseline assessments. The entrepreneurship modules will occur for 15 days for 5 hours each day, 5 days per week. Immediately following the EPP, youth will begin receiving the YRI. The YRI curriculum (12 modules), will be delivered twice weekly over the course of 6 weeks. Each session lasts approximately 90-minutes, with additional time taken as needed. These 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 quantitative assessment.

Behavioral: YRI; Behavioral: EPP

Control

NO INTERVENTION

Control: Youth randomized into the control arm will be quantitatively assessed at the same time points as youth randomized into the two treatment arms (baseline and post-intervention). Due to access to funding and feasibility, youth in the control 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. The list of youth from the control group will be provided to GIZ so they can participate in the future phases. Youth will also be compensated for their participation in our quantitative assessments.

Interventions

YRI BEHAVIORAL

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.

Also known as: Youth Readiness Intervention

EPP+YRI

EPP BEHAVIORAL

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.

Also known as: Youth Employment Promotion Programme

EPP+YRI; EPP: Entrepreneurship Programme

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• developmental disability that precludes comprehension of the intervention content and assessments (as determined by a study social worker using the World Health Organization Disability Assessment Screener within the Youth Screening Tool available in Appendix C).
• 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, as assessed via the Youth Screening tool (Appendix C).
• 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:
• they are under age 18

Sponsors & Collaborators

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

Study Sites (1)

CARITAS

Freetown, Sierra Leone

Location

Related Publications (2)

• 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 standard CTS training condition nor the ICT 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: 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.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: July 27, 2018
• Study Start: July 31, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

SI (1)