Clinical trial NCT07008950: Self-efficacy and Knowledge (SEEK) Trial to Improve Sexual Reproductive Health and Well-being for Syrian Refugee Women and Girls in Lebanon
Official title: Self-efficacy and Knowledge (SEEK) Trial to Improve Sexual Reproductive Health and Well-being for Syrian Refugee Women and Girls in Lebanon
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Care
Sexual Health Quality of Life
Family Planning Services
Keywords: sexual health
reproductive health
psychosocial support
wellbeing
RCT
Lebanon
Refugees
Girls and young women
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Elrha
First posted: 2025-06-06
Enrollment: 485
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will report on a community based RCT in which syrian refugee women and girls aged 15-24 recruited from 2 PHCs in Lebanon were randomly allocated into control and experimental groups. The aim is to examine changes in key outcomes of sexual reproductive health, family planning, and wellbeing as a result of receiving the WHO-developed integrated intervention package. The experimental group will receive the intervention package by attending 8 sessions on this topic over a period of 8 weeks. The control group will not receive the intervention package.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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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:

1. are currently married and between the ages of 15 - 24 years,
2. completed an average stay in Lebanon for a minimum of 6 months,
3. 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,
4. have none of the exclusion criteria listed below upon screening.

Exclusion Criteria:

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

1. are currently pregnant and/or lactating,
2. have reported chronic health problems interfering with the ability to follow the intervention protocol,
3. 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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Primary outcomes:
measure: Family Planning Use
timeFrame: From enrollement until 3 months post intervention delivery
Secondary outcomes:
measure: Anxiety and Depression Measure
timeFrame: From enrollment until 3 months post intervention
measure: General Wellbeing Measure
timeFrame: From enrollment until the end of 3 months post treatment follow up
measure: Self Efficacy Measure
timeFrame: From enrollment until the end of the intervention at 3 months post treatment
measure: Perceived Social Support Measure
timeFrame: From enrollment until the end of the intervention at 3 months post treatment
Other outcomes:
measure: Emotional Regulation Measure
timeFrame: From enrollement until 3 months post intervention delivery
measure: Interpersonal Communication Measure
timeFrame: From enrollment until 3 months post intervention
measure: Ways of Coping Measure
timeFrame: From enrollment until 3 months post intervention
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: Global Health Institute American University of Beirut
name: Shadi Saleh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: World Health Organization
name: Lale Say, MD
role: PRINCIPAL_INVESTIGATOR
References: