NCT03603613

Youth FORWARD Phase 1 YRI and EPP Study

Completed NA Last updated 3 June 2019

What this trial tests

NA trial testing YRI in Mental Health Disorder in 297 participants. Completed in 1 March 2019.

Timeline

31 July 2018

Primary endpoint
1 March 2019

1 March 2019

Quick facts

Lead sponsor	Boston College
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	297
Start date	31 July 2018
Primary completion	1 March 2019
Estimated completion	1 March 2019
Sites	1 location across Sierra Leone

Drugs / interventions tested

• YRI
• EPP

Conditions studied

• Mental Health Disorder — all drugs for Mental Health Disorder →
• Mental Health Impairment — all drugs for Mental Health Impairment →
• Psychosocial Impairment — all drugs for Psychosocial Impairment →
• Emotional Dysfunction — all drugs for Emotional Dysfunction →

Sponsor

Boston College

Who can join

Adults 18 to 26, any sex, with Mental Health Disorder or Mental Health Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Youth Functioning and Organizational Success for West African Regional Development (Youth FORWARD): Study Protocol.
   Betancourt TS, Hansen N, Farrar J, Borg RC, et al · · 2021 · cited 12× · PMID 33291974 · DOI 10.1176/appi.ps.202000009
2. Alternative Delivery Platforms for Expanding Evidence-based Mental Health Interventions for Youth in Sierra Leone: A Pilot Study.
   Desrosiers A, Freeman J, Mitra R, Bond L, et al · · 2023 · cited 10× · PMID 36684805 · DOI 10.1080/17450128.2022.2094518
3. Alternate delivery platforms and implementation models for bringing evidence-based behavioral interventions to scale for youth facing adversity: a case study in West Africa.
   Bond L, Farrar J, Borg RC, Keegan K, et al · · 2022 · cited 4× · PMID 35168661 · DOI 10.1186/s43058-022-00259-5
4. Alternate Delivery Platforms and Implementation Models for Bringing Evidence-Based Behavioral Interventions to Scale for Youth Facing Adversity: A Case Study in West Africa
   Bond L, Farrar J, Borg RC, Keegan K, et al · · 2021 · DOI 10.21203/rs.3.rs-369401/v1
5. Alternate Delivery Platforms and Implementation Models for Bringing Evidence-Based Behavioral Interventions to Scale for Youth Facing Adversity: A Case Study in West Africa
   Bond L, Farrar J, Borg RC, Keegan K, et al · · 2021 · DOI 10.21203/rs.3.rs-300525/v1