Adapting Group PM+ for Venezuelan Refugees and Migrants in Colombia

Mental Health Wellness 1 Clinical Trial

Official title: Increasing Mental Health and Psychosocial Social Support for Venezuelan Refugees and Migrants: Adapting Group Problem Management Plus (Group PM+) for Venezuelan Refugees and Migrants in Colombia

Status Recruiting

Clinical Trial Summary

This study is a type 2 hybrid implementation design, which aims to evaluate the utility and effectiveness of an intervention while simultaneously assessing implementation outcomes, such as adoption, fidelity, and maintenance. The aim is to compare participant level outcomes when the intervention is delivered by facilitators that are trained and supervised by psychologists versus by lay-supervisors. Group PM+ will be delivered to participants in two phases: first, with high levels of technical support through intensive training and supervision by mental health professionals and a second phase with routine service delivery and supervision. Non-specialist community members who are trained and supervised by psychologists to deliver PM+ as part of Phase 1 will be trained to become supervisors and train and support a cohort of new non-specialist facilitators for Group PM+ delivery in Phase 2. This model employs a train-the-trainers model to replicate routine service delivery especially in settings where mental health specialists may not be available to provide robust technical support and supervision to lay PM+ facilitators. The aim is to compare effectiveness and implementation outcomes of Group PM+ when delivered within routine care, to identify best practices for implementation, and ultimately, to shorten the time lag between intervention research and routine uptake.

Clinical Trial Description

This study is a type 2 hybrid implementation design, which aims to evaluate the utility and effectiveness of an intervention while simultaneously assessing implementation outcomes, such as adoption, fidelity, and maintenance. The aim is to compare participant level outcomes when the intervention is delivered by facilitators that are trained and supervised by psychologists versus by lay-supervisors. Group PM+ will be delivered to participants in two phases: first, with high levels of technical support through intensive training and supervision by mental health professionals and a second phase with routine service delivery and supervision. Non-specialist community members who are trained and supervised by psychologists to deliver PM+ as part of Phase 1 will be trained to become supervisors and train and support a cohort of new non-specialist facilitators for Group PM+ delivery in Phase

2. This model employs a train-the-trainers model to replicate routine service delivery especially in settings where mental health specialists may not be available to provide robust technical support and supervision to lay PM+ facilitators. The aim is to compare effectiveness and implementation outcomes of Group PM+ when delivered within routine care, to identify best practices for implementation, and ultimately, to shorten the time lag between intervention research and routine uptake.

This research design offers a few points of comparison:

1. change in primary and secondary outcomes at 1-week follow-up and 3-month follow-up amongst participants that receive Group PM+ with research support (Phase 1) compared to those that receive the intervention with standard care and implementation (Phase 2), [Primary objective]

2. differences in implementation indicators (ex. Facilitator competencies, fidelity to PM+, participant retention, cost effectiveness, adverse events, human resource involvement and more) in Phase 1 of implementation compared to Phase 2,

3. change in primary and secondary outcomes amongst participants in the intervention arm compared to participants who do not receive the intervention during Phase 1. ;

Related Conditions & MeSH terms

• Mental Health Wellness 1

• NCT number: NCT05477355
• Study type: Interventional
• Source: The New School
• Contact: Manaswi Sangraula, PhD
• Phone: 5712308443
• Email: sangraum@newschool.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Completion date: December 31, 2022