RESETTLE-IDPs: Life-Skills Education and Psychosocial Resilience Building for Displaced Nigerians

NCT06412679 | Active Not Recruiting

• 3 other identifiers: 2024-7085PAA - 192178R-HGC-POC-2408-67370
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Mental Health; Psychosocial Functioning; Implementation Science; Global Health; Conflict

Keywords

Conflict; Forced Displacement; Internally displaced persons; Mental health; Psychosocial support; Life skills education; Mobile health; Digital health; Humanitarian emergencies; Global mental health

Outcome Measures

Primary Outcomes (1)

• Change in Post-Traumatic Stress Disorder (PTSD) symptoms

  Metric/Method of Measurement: PTSD Checklist for DSM-5 (PCL-5) The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria. Participants rate how much they have been bothered by each symptom in the past month on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The total score ranges from 0 to 80, with higher scores indicating greater severity of PTSD symptoms. A score of 31-33 or higher suggests probable PTSD diagnosis.

  Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (6)

• Change in depressive symptoms

  Baseline, 3 months, 6 months, and 12 months

• Change in anxiety symptoms

  Baseline, 3 months, 6 months, and 12 months

• Change in life skills

  Baseline, 3 months, 6 months, and 12 months

• Change in well-being

  Baseline, 3 months, 6 months, and 12 months

• Change in perceived appropriateness of the intervention

  Baseline, 3 months

Study Arms (2)

In-Person Life Skills Education (LSE) Peer Support Groups

ACTIVE COMPARATOR

Participants will receive a culturally-adapted LSE intervention delivered through weekly in-person peer support group sessions for 12 weeks. The LSE curriculum covers topics such as stress management, communication skills, problem-solving, emotion regulation, health and hygiene, social skills, gender norms and safety, education and livelihoods, and community mobilization. Each peer support group will consist of 10-12 participants, separated by gender and age bands (12-17 and 18-24 for youth, 18+ for women), and will meet weekly for approximately 2 hours in a private, safe space within the IDP camp. Sessions will be co-facilitated by a trained IDP peer leader and a local mental health provider, following a structured format with interactive activities, discussions, and skill practice.

Behavioral: Life Skills Education

WhatsApp-Enabled LSE Virtual Peer Support Groups

ACTIVE COMPARATOR

Participants will receive the same culturally-adapted LSE curriculum as those in the In-person arm, but delivered through WhatsApp for 12 weeks. Participants will be added to a moderated WhatsApp group chat with other IDP youth or women in their camp, where they will receive three LSE-related messages per week. These messages will include brief psychoeducational content, practice exercises, reflection prompts, and reminders to engage with the virtual support group. The WhatsApp group will provide a platform for participants to discuss the LSE topics, share experiences and coping strategies, and provide emotional support to one another, with trained IDP peer facilitators moderating the chats to ensure a safe and supportive environment. Participants will also receive regular push notifications with motivational messages, links to further resources, and reminders to practice the LSE skills.

Behavioral: Life Skills Education

Interventions

Life Skills Education BEHAVIORAL

The RESETTLE-IDPs study compares two innovative delivery approaches for a culturally-adapted life skills education (LSE) intervention aimed at improving the mental health and well-being of internally displaced persons in Nigeria. The interventions are distinguished by their mode of delivery (in-person vs. WhatsApp-based), their focus on peer support and skill-building, and their tailoring to the specific needs and challenges of IDP populations.

In-Person Life Skills Education (LSE) Peer Support Groups; WhatsApp-Enabled LSE Virtual Peer Support Groups

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 13 years and above
• Ownership of smartphone
• Internally displaced for at least 6 months.
• Residing in select IDP camps in Abuja and Borno State, Nigeria
• Fluency in English and/or Hausa languages
• Willing and able to provide informed consent.

You may not qualify if:

• Active suicidal ideation or attempts (i.e having thoughts, plans, or intent to end one\'s life within the past month)
• Active psychosis
• Cognitive impairment precluding informed consent or survey completion.
• Not owning as smartphone

Sponsors & Collaborators

• Dalhousie University: lead
• University of Maiduguri Teaching Hospital: collaborator
• Brooks Insights Limited: collaborator

Study Sites (1)

Wassa and Durumi IDP camps

Abuja, Federal Capital Territory, 900001, Nigeria

Location

Related Publications (10)

• Kaiser BN, Ticao C, Boglosa J, Minto J, Chikwiramadara C, Tucker M, Kohrt BA. Mental health and psychosocial support needs among people displaced by Boko Haram in Nigeria. Glob Public Health. 2020 Mar;15(3):358-371. doi: 10.1080/17441692.2019.1665082. Epub 2019 Sep 19.

  PMID: 31535595 BACKGROUND

• Ugbe UM, Esu EB, Efut JA, Bisongedam MM, Awa TM, Ekpo OI. Sociodemographic correlates and associated factors of depression and anxiety among internally displaced adults in Ogoja, Nigeria. Gen Psychiatr. 2022 Apr 28;35(2):e100749. doi: 10.1136/gpsych-2022-100749. eCollection 2022.

  PMID: 35572773 BACKGROUND

• Wei Y, Hayden JA, Kutcher S, Zygmunt A, McGrath P. The effectiveness of school mental health literacy programs to address knowledge, attitudes and help seeking among youth. Early Interv Psychiatry. 2013 May;7(2):109-21. doi: 10.1111/eip.12010. Epub 2013 Jan 24.

  PMID: 23343220 BACKGROUND

• Taubner S, Ioannou Y, Saliba A, Sales CMD, Volkert J, Protic S, Adler A, Barkauskiene R, Conejo-Ceron S, Di Giacomo D, Mestre JM, Moreno-Peral P, Vieira FM, Mota CP, Henriques MIRS, Rossberg JI, Perdih TS, Schmidt SJ, Zettl M, Ulberg R, Heinonen E. Mediators of outcome in adolescent psychotherapy and their implications for theories and mechanisms of change: a systematic review. Eur Child Adolesc Psychiatry. 2024 Oct;33(10):3321-3358. doi: 10.1007/s00787-023-02186-9. Epub 2023 Mar 15.

  PMID: 36918434 BACKGROUND

• Sahebalzamani M, Farahani H, Feizi F. Efficacy of life skills training on general health in students. Iran J Nurs Midwifery Res. 2012 Nov;17(7):553-5.

  PMID: 23922605 BACKGROUND

• Singla DR, Waqas A, Hamdani SU, Suleman N, Zafar SW, Zill-E-Huma, Saeed K, Servili C, Rahman A. Implementation and effectiveness of adolescent life skills programs in low- and middle-income countries: A critical review and meta-analysis. Behav Res Ther. 2020 Jul;130:103402. doi: 10.1016/j.brat.2019.04.010. Epub 2019 Apr 26.

  PMID: 31146889 BACKGROUND

• Maghsoudi J, Sabour NH, Yazdani M, Mehrabi T. The effect of acquiring life skills through humor on social adjustment rate of the female students. Iran J Nurs Midwifery Res. 2010 Fall;15(4):195-201.

  PMID: 22049280 BACKGROUND

• Magnani R, Macintyre K, Karim AM, Brown L, Hutchinson P, Kaufman C, Rutenburg N, Hallman K, May J, Dallimore A; Transitions Study Team. The impact of life skills education on adolescent sexual risk behaviors in KwaZulu-Natal, South Africa. J Adolesc Health. 2005 Apr;36(4):289-304. doi: 10.1016/j.jadohealth.2004.02.025.

  PMID: 15780784 BACKGROUND

• undefined

  BACKGROUND

• Eboreime E, Obi-Jeff C, Orji R, Ojo TM, Iyamu I, Harri BI, Said JM, Oguntimehin F, Ibrahim A, Anjorin O, Duke AEE, Musami UB, Liebenberg L, Crider R, Wagami L, Dahiru AM, Uneke JC, Yaya S, Agyapong VI. In-person vs mobile app facilitated life skills education to improve the mental health of internally displaced persons in Nigeria: protocol for the RESETTLE-IDPs cluster randomized hybrid type 2 effectiveness-implementation trial. BMC Health Serv Res. 2024 Oct 22;24(1):1269. doi: 10.1186/s12913-024-11762-x.

  PMID: 39438885 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Ejemai A Eboreime, MBBS, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Vincent Agyapong, MD, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Rita Orji, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Sanni Yaya, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Type II Hybrid Effectiveness-Implementation Design

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Access Criteria: Data Sharing Statement We will share de-identified IPD underlying the published results of the RESETTLE-IDPs study, including the study protocol, statistical analysis plan, and analytic code. IPD will be made available upon reasonable request and after approval by the study's steering committee, subject to a data sharing agreement. Access Criteria and Procedure Researchers interested in accessing the IPD should submit a formal request to the study's principal investigator, specifying the purpose, scope, and timeline of the proposed analyses. Requests will be reviewed by the steering committee based on the scientific merit, feasibility, and alignment with the study's objectives and participants' informed consent.

Locations

NG (1)