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

Not Applicable

Recruiting

• Conditions: Mental Health Care; Sexual Health Quality of Life; Family Planning Services

• Registration Number: NCT07008950
• Lead Sponsor: American University of Beirut Medical Center

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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2025-02-28
• Primary Completion: 2025-05-01
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 485

Inclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Family Planning Use	From enrollement until 3 months post intervention delivery	Improvement in family planning use among the EG compared to the CG at 3 months post intervention. This will be measured using the Pan Arab-Family Health (PAPFAM) survey. This is a descriptive tool with values indicating use or no use of family planning services. It is not scored, but rather yields un-scored percentages. Higher percentages may mean worse or better outcomes depending on the question.

Secondary Outcome Measures

Name	Time	Method
Anxiety and Depression Measure	From enrollment until 3 months post intervention	Improved well-being among the EG compared to the CG at 3 months post intervention. One of the dimensions to assess well being includes: - anxiety and depression using the Hopkins Symptom Checklist-25 (values range from 1 to 4 per question with higher scores indicating worse outcomes)
General Wellbeing Measure	From enrollment until the end of 3 months post treatment follow up	Improved well-being among the EG compared to the CG at 3 months post intervention. One of the dimensions to assess well being includes: - general wellbeing using the World Health Organization-5 questionnaire (values range from 0 to 5 per question with higher scores indicating better outcomes),
Self Efficacy Measure	From enrollment until the end of the intervention at 3 months post treatment	Improved well-being among the EG compared to the CG at 3 months post intervention. One of the dimensions to assess well being includes: - self efficacy using the General Self-Efficacy Scale (values range from 1 to 4 per question, with higher scores indicating better outcomes)
Perceived Social Support Measure	From enrollment until the end of the intervention at 3 months post treatment	Improved well-being among the EG compared to the CG at 3 months post intervention. One of the dimensions to assess well being includes: - perceived social support using the Multidimensional Scale of Perceived Social Support for Arab Women (values range from 1 to 7 per question with higher scores indicating better outcomes)

Trial Locations

Locations (1)

American University of Beirut; 🇱🇧 Beirut, Lebanon