Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412679
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-09
Brief Title:
RESETTLE-IDPs Life-Skills Education and Psychosocial Resilience Building for Displaced Nigerians
Sponsor:
Dalhousie University
Organization:
Dalhousie University
Study Overview
Official Title:
Rebuilding Emotional Stability and Strength Through Therapeutic and Life-Skills Education for Internally Displaced Persons in Nigeria RESETTLE-IDPs A Hybrid Type II Effectiveness-implementation Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESETTLE-IDPs
Brief Summary:
The RESETTLE-IDPs study aims to address the urgent mental health needs of internally displaced youth and women in Nigeria who face high rates of depression anxiety and post-traumatic stress due to exposure to conflict violence and loss Despite the immense needs there is a severe lack of culturally appropriate evidence-based interventions to support the resilience and well-being of these vulnerable populations
To fill this gap the study will evaluate the effectiveness and implementation of a novel life skills education LSE program delivered through two innovative approaches in-person peer support groups and WhatsApp-based virtual support groups The LSE curriculum developed through extensive community engagement covers topics such as stress management communication problem-solving health safety and advocacy all tailored to the unique challenges of displacement
In the in-person arm trained IDP peers and local providers will facilitate weekly group sessions over 12 weeks providing a safe space for participants to learn practice and apply new skills while building social connections and support networks In the WhatsApp arm participants will receive weekly messages with educational content reflection prompts and exercises moderated by trained facilitators to foster dialogue and peer support
By comparing these two delivery methods the study aims to identify the most feasible acceptable and effective strategies for rolling out psychosocial support interventions in humanitarian settings particularly those with limited resources and access The study will also assess the interventions impact on key mental health outcomes including depression anxiety PTSD and well-being as well as life skills functioning and implementation metrics such as reach adoption and sustainability
Ultimately the RESETTLE-IDPs study seeks to generate actionable evidence to inform the development and scale-up of culturally responsive community-driven interventions that can promote the mental health and resilience of conflict-affected populations in Nigeria and beyond By empowering IDP youth and women with the knowledge skills and support to navigate the challenges of displacement the study aims to contribute to a brighter more hopeful future for these resilient communities
To fill this gap the study will evaluate the effectiveness and implementation of a novel life skills education LSE program delivered through two innovative approaches in-person peer support groups and WhatsApp-based virtual support groups The LSE curriculum developed through extensive community engagement covers topics such as stress management communication problem-solving health safety and advocacy all tailored to the unique challenges of displacement
In the in-person arm trained IDP peers and local providers will facilitate weekly group sessions over 12 weeks providing a safe space for participants to learn practice and apply new skills while building social connections and support networks In the WhatsApp arm participants will receive weekly messages with educational content reflection prompts and exercises moderated by trained facilitators to foster dialogue and peer support
By comparing these two delivery methods the study aims to identify the most feasible acceptable and effective strategies for rolling out psychosocial support interventions in humanitarian settings particularly those with limited resources and access The study will also assess the interventions impact on key mental health outcomes including depression anxiety PTSD and well-being as well as life skills functioning and implementation metrics such as reach adoption and sustainability
Ultimately the RESETTLE-IDPs study seeks to generate actionable evidence to inform the development and scale-up of culturally responsive community-driven interventions that can promote the mental health and resilience of conflict-affected populations in Nigeria and beyond By empowering IDP youth and women with the knowledge skills and support to navigate the challenges of displacement the study aims to contribute to a brighter more hopeful future for these resilient communities
Detailed Description:
The RESETTLE-IDPs study is a cluster-randomized type II effectiveness-implementation hybrid trial that aims to evaluate the effectiveness and implementation of a life skills education LSE intervention delivered through two innovative approaches - in-person peer support groups and WhatsApp-based virtual support groups - to improve the mental health and well-being of internally displaced persons in Nigeria
Background and Rationale
Nigeria is facing a severe humanitarian crisis with over 27 million people internally displaced due to armed conflict communal violence and natural disasters Internally displaced persons IDPs in Nigeria particularly youth and women are at high risk of mental health problems such as depression anxiety and post-traumatic stress disorder PTSD due to exposure to trauma loss and ongoing stressors Despite the immense needs there is a severe lack of culturally appropriate evidence-based interventions to support the mental health and resilience of IDP populations in Nigeria and other low-resource humanitarian settings
Life skills education LSE is a promising approach to promoting mental health and well-being among conflict-affected populations LSE programs aim to equip individuals with the knowledge attitudes and skills needed to navigate challenges cope with stress and make healthy decisions Previous studies have shown that LSE interventions can improve mental health outcomes social-emotional learning and positive youth development in various contexts However there is limited evidence on the effectiveness and implementation of LSE programs specifically tailored for IDP youth and women in Nigeria and how different delivery methods eg in-person vs mobile-based may impact their reach acceptability and sustainability
Study Objectives
The primary objective of the RESETTLE-IDPs study is to evaluate the effectiveness of a 12-week LSE intervention delivered through either in-person peer support groups or WhatsApp-based virtual support groups on mental health outcomes depression anxiety PTSD and well-being among IDP youth and women in Nigeria compared to a wait-list control group
Secondary objectives include
1 To assess the impact of the LSE intervention on life skills acquisition daily functioning and social support among IDP youth and women
2 To compare the feasibility acceptability fidelity and cost-effectiveness of in-person vs WhatsApp-based delivery methods for the LSE intervention
3 To explore the contextual factors implementation processes and mechanisms of change that influence the effectiveness and sustainability of the LSE intervention in IDP settings
4 To engage stakeholders IDP communities health workers humanitarian organizations policymakers in the design implementation and evaluation of the LSE intervention to promote its cultural relevance ownership and scalability
Methods The study will use a three-arm cluster-randomized controlled trial design with IDP camps in Nigeria randomly allocated to one of two groups 1 in-person LSE peer support groups 2 WhatsApp-based LSE virtual support groups The target population includes IDPs youth aged 13 years and above residing in selected camps in Borno State the epicenter of the Boko Haram insurgency and displacement crisis in Nigeria
The intervention will consist of a culturally adapted LSE curriculum covering topics such as stress management communication skills problem-solving health and hygiene safety and protection gender norms and community mobilization The curriculum will be developed through a participatory process involving IDP youth and women community leaders health workers and education specialists drawing on existing evidence-based resources and guidelines eg UNICEF LSE Toolkit
In the in-person arm trained IDP peers and local providers will facilitate weekly gender- and age-segregated support groups of 10-12 participants over a 12-week period The groups will provide a safe space for participants to learn and practice life skills share experiences and provide mutual support Sessions will use interactive experiential learning methods such as role-plays discussions and group projects
In the WhatsApp arm participants will be enrolled in moderated virtual support groups that deliver the LSE curriculum through weekly conversations including psychoeducational content reflection prompts skill-building exercises and peer discussion topics Trained IDP facilitators will moderate the groups to ensure safe and supportive interactions provide feedback and encourage skill application
The study will enroll a total of 500 participants 250 per arm across 20 IDP camps with an estimated 25 participants per camp Participants will be recruited through community-based mobilization strategies with support from camp leaders health workers and NGO partners
Data will be collected at baseline 3 months 6 months and 12 months using a combination of quantitative and qualitative methods Quantitative data will include validated mental health scales as well as locally adapted measures of life skills functioning and social support Qualitative data will include in-depth interviews and focus group discussions with participants facilitators and stakeholders to explore experiences perceptions and contextual factors influencing the intervention
Data analysis will use an intent-to-treat approach with mixed-effects regression models to assess intervention effects on primary and secondary outcomes accounting for clustering at the camp level Qualitative data will be analyzed thematically to identify barriers facilitators and mechanisms of change Implementation outcomes eg reach fidelity acceptability will be assessed using process evaluation frameworks eg RE-AIM
Expected Results and Impact
The RESETTLE-IDPs study aims to generate rigorous evidence on the effectiveness and implementation of a culturally adapted LSE intervention for improving the mental health and well-being of IDP youth and women in Nigeria The study findings will have important implications for the design delivery and scale-up of psychosocial support interventions in humanitarian settings particularly those affected by conflict and displacement
By comparing in-person and WhatsApp-based delivery methods the study will provide valuable insights into the relative advantages challenges and effectiveness of different approaches to reaching and engaging IDP populations The use of implementation science frameworks and participatory research methods will ensure that the intervention is not only effective but also feasible acceptable and sustainable in real-world contexts
The study will also contribute to capacity-building and empowerment of IDP communities by training and engaging youth and women as peer facilitators researchers and advocates The participatory approach aims to foster local ownership leadership and sustainability of the intervention beyond the research period
Ultimately the RESETTLE-IDPs study has the potential to inform policy practice and funding priorities for mental health and psychosocial support in humanitarian settings both in Nigeria and globally By advancing the evidence base on culturally relevant community-based interventions the study can contribute to reducing the global burden of mental health disorders and promoting the resilience and well-being of conflict-affected populations
Background and Rationale
Nigeria is facing a severe humanitarian crisis with over 27 million people internally displaced due to armed conflict communal violence and natural disasters Internally displaced persons IDPs in Nigeria particularly youth and women are at high risk of mental health problems such as depression anxiety and post-traumatic stress disorder PTSD due to exposure to trauma loss and ongoing stressors Despite the immense needs there is a severe lack of culturally appropriate evidence-based interventions to support the mental health and resilience of IDP populations in Nigeria and other low-resource humanitarian settings
Life skills education LSE is a promising approach to promoting mental health and well-being among conflict-affected populations LSE programs aim to equip individuals with the knowledge attitudes and skills needed to navigate challenges cope with stress and make healthy decisions Previous studies have shown that LSE interventions can improve mental health outcomes social-emotional learning and positive youth development in various contexts However there is limited evidence on the effectiveness and implementation of LSE programs specifically tailored for IDP youth and women in Nigeria and how different delivery methods eg in-person vs mobile-based may impact their reach acceptability and sustainability
Study Objectives
The primary objective of the RESETTLE-IDPs study is to evaluate the effectiveness of a 12-week LSE intervention delivered through either in-person peer support groups or WhatsApp-based virtual support groups on mental health outcomes depression anxiety PTSD and well-being among IDP youth and women in Nigeria compared to a wait-list control group
Secondary objectives include
1 To assess the impact of the LSE intervention on life skills acquisition daily functioning and social support among IDP youth and women
2 To compare the feasibility acceptability fidelity and cost-effectiveness of in-person vs WhatsApp-based delivery methods for the LSE intervention
3 To explore the contextual factors implementation processes and mechanisms of change that influence the effectiveness and sustainability of the LSE intervention in IDP settings
4 To engage stakeholders IDP communities health workers humanitarian organizations policymakers in the design implementation and evaluation of the LSE intervention to promote its cultural relevance ownership and scalability
Methods The study will use a three-arm cluster-randomized controlled trial design with IDP camps in Nigeria randomly allocated to one of two groups 1 in-person LSE peer support groups 2 WhatsApp-based LSE virtual support groups The target population includes IDPs youth aged 13 years and above residing in selected camps in Borno State the epicenter of the Boko Haram insurgency and displacement crisis in Nigeria
The intervention will consist of a culturally adapted LSE curriculum covering topics such as stress management communication skills problem-solving health and hygiene safety and protection gender norms and community mobilization The curriculum will be developed through a participatory process involving IDP youth and women community leaders health workers and education specialists drawing on existing evidence-based resources and guidelines eg UNICEF LSE Toolkit
In the in-person arm trained IDP peers and local providers will facilitate weekly gender- and age-segregated support groups of 10-12 participants over a 12-week period The groups will provide a safe space for participants to learn and practice life skills share experiences and provide mutual support Sessions will use interactive experiential learning methods such as role-plays discussions and group projects
In the WhatsApp arm participants will be enrolled in moderated virtual support groups that deliver the LSE curriculum through weekly conversations including psychoeducational content reflection prompts skill-building exercises and peer discussion topics Trained IDP facilitators will moderate the groups to ensure safe and supportive interactions provide feedback and encourage skill application
The study will enroll a total of 500 participants 250 per arm across 20 IDP camps with an estimated 25 participants per camp Participants will be recruited through community-based mobilization strategies with support from camp leaders health workers and NGO partners
Data will be collected at baseline 3 months 6 months and 12 months using a combination of quantitative and qualitative methods Quantitative data will include validated mental health scales as well as locally adapted measures of life skills functioning and social support Qualitative data will include in-depth interviews and focus group discussions with participants facilitators and stakeholders to explore experiences perceptions and contextual factors influencing the intervention
Data analysis will use an intent-to-treat approach with mixed-effects regression models to assess intervention effects on primary and secondary outcomes accounting for clustering at the camp level Qualitative data will be analyzed thematically to identify barriers facilitators and mechanisms of change Implementation outcomes eg reach fidelity acceptability will be assessed using process evaluation frameworks eg RE-AIM
Expected Results and Impact
The RESETTLE-IDPs study aims to generate rigorous evidence on the effectiveness and implementation of a culturally adapted LSE intervention for improving the mental health and well-being of IDP youth and women in Nigeria The study findings will have important implications for the design delivery and scale-up of psychosocial support interventions in humanitarian settings particularly those affected by conflict and displacement
By comparing in-person and WhatsApp-based delivery methods the study will provide valuable insights into the relative advantages challenges and effectiveness of different approaches to reaching and engaging IDP populations The use of implementation science frameworks and participatory research methods will ensure that the intervention is not only effective but also feasible acceptable and sustainable in real-world contexts
The study will also contribute to capacity-building and empowerment of IDP communities by training and engaging youth and women as peer facilitators researchers and advocates The participatory approach aims to foster local ownership leadership and sustainability of the intervention beyond the research period
Ultimately the RESETTLE-IDPs study has the potential to inform policy practice and funding priorities for mental health and psychosocial support in humanitarian settings both in Nigeria and globally By advancing the evidence base on culturally relevant community-based interventions the study can contribute to reducing the global burden of mental health disorders and promoting the resilience and well-being of conflict-affected populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PAA - 192178 | OTHER_GRANT | None | None |
| R-HGC-POC-2408-67370 | OTHER_GRANT | Grand Challenges Canada | None |