Self-efficacy and Knowledge (SEEK) Trial to Improve Sexual Reproductive Health and Well-being for Syrian Refugee Women and Girls in Lebanon

Обзор

This community-based randomized controlled trial (RCT) aims to evaluate a low-resource/low-intensity integrated sexual reproductive health (SRH) and wellbeing intervention package. It will be delivered in Primary Healthcare Centres (PHCs) in a rural area in Lebanon to Syrian refugee women and girls aged 15-24.

Подробное описание

Use and access to sexual and reproductive health (SRH) services are often inadequate and limited among adolescent girls and young refugee women in humanitarian settings. This is attributed to an array of factors including: limited health literacy, lack of knowledge on where and how to access services, limited availability of services, and gender norms. Further, the nature of humanitarian settings often poses additional mental health pressures because of limited safety, political instability, gender-based violence (GBV), and dire socio-economic and living conditions, among others. This is especially true for the Eastern Mediterranean Region (EMR), which hosts the largest number of humanitarian crises in the world, thus rendering the provision of SRH and psychosocial support (PSS) services in humanitarian settings highly compromised.

The proposed research aims to evaluate the impact of a WHO-developed low-intensity/low-resource psychosocial support (PSS) SRH-integrated intervention package on the use of selected SRH services, primarily family planning as well as well-being among Syrian adolescent girls and young women refugees, aged 15-24 years, in Lebanon. The research will adopt a community-based randomized controlled trial (RCT) design to evaluate the effectiveness of the PSS-SRH integrated intervention package on the use of selected SRH services as well as mental well-being. The RCT will be accompanied by a rigorous process evaluation during intervention implementation to assess intervention fidelity, attrition, dose and satisfaction, as well as to capture key lessons based on intervention implementation to inform global scale-up in different humanitarian settings.

This intervention is expected to be easily integrated into existing primary healthcare settings and specifically to improve selected SRH service use, leading to improved SRH outcomes and reduced SRH-related risks, and ultimately better wellbeing among refugee women and girls. Findings of this RCT are also expected to inform key stakeholders and better guide decision making for such interventions in humanitarian settings.

Вмешательства

• Другое The Self-Efficacy and Knowledge Trial
  The intervention is composed on 8 sessions given over a period of 8 weeks covering topics of emotional regulation, communication, problem management, decision making, self-efficacy and others in relation to sexual reproductive health, family planning, and wellbeing. The intervention package will be delivered by trained non-specialists with at least 12 years of formal education. The package will be administered once a week for a duration of 90 minutes.

Первичные конечные точки

• Family Planning Use [Срок оценки: From enrollement until 3 months post intervention delivery]

Вторичные конечные точки (4)

• Anxiety and Depression Measure [Срок оценки: From enrollment until 3 months post intervention]
• General Wellbeing Measure [Срок оценки: From enrollment until the end of 3 months post treatment follow up]
• Self Efficacy Measure [Срок оценки: From enrollment until the end of the intervention at 3 months post treatment]
• Perceived Social Support Measure [Срок оценки: From enrollment until the end of the intervention at 3 months post treatment]

Критерии участия

Критерии включения

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The target population of the study are Syrian adolescent girls and young women refugees (age 15-24 years) residing in Beqaa governorate in Lebanon. Participants will be included in the study if they meet the following inclusion criteria:

• are currently married and between the ages of 15 - 24 years,
• completed an average stay in Lebanon for a minimum of 6 months,
• are willing to take part in the study as indicated by them signing an informed consent (for young women 18 years of age or older) or through a legal guardian consent form and written assent for adolescents' girls between 15 and 17,
• have none of the exclusion criteria listed below upon screening.

Критерии исключения

Participants will be excluded from the study if they meet any of the following criteria:

• are currently pregnant and/or lactating,
• have reported chronic health problems interfering with the ability to follow the intervention protocol,
• have high levels of anxiety and/or depression as well as suicidal ideations and/or attempts upon screening and/or a current diagnosis of a severe mental illness, or undergoing mental health treatment.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Ливан · 1 центр

• American University of Beirut — Beirut

Публикации

• Saleh S, Naal H, Dakdouki AE, Chamseddine Z, Govender V, Sarieddine D, AbouHaidar GH, Bosqui T, Tamim H, Fouad F, Ibrahim S, Sater ZA, Vanderkruik R, Say L. Process evaluation of an integrated community-based intervention to improve family planning, sexual reproductive Health, and wellbeing among Syrian refugee women and girls in Lebanon during active conflict. Confl Health. 2026 Jan 17;20(1):13. PMID 41547889
• Sarieddine D, Chamseddine Z, Naal H, Dakdouki AE, Haidar GHA, Tamim H, Bosqui T, Fouad F, Ibrahim S, Sater ZA, Saleh S. Correlates of sexually transmitted infections among Syrian refugee women and girls in Lebanon: knowledge, symptoms, and health-seeking behaviors. BMC Womens Health. 2025 Oct 8;25(1):477. doi: 10.1186/s12905-025-04036-z. PMID 41063145

Идентификаторы

NCT: NCT07008950 · SBS-2023-0310 · 78689

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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