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| ID | Type | Description | Link |
|---|---|---|---|
| 78689 | Other Identifier | ELRHA |
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| Name | Class |
|---|---|
| World Health Organization | OTHER |
| Elrha | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group receiving SEEK intervention | Experimental | Participants randomly assigned to the experimental group will be further randomly assigned to 16 subgroups of no more than 12 participants per groups to receive the SEEK integrated intervention package on sexual reproductive health, family planning, and wellbeing. |
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| Control group not receiving SEEK intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Self-Efficacy and Knowledge Trial | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Family Planning Use | 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. | From enrollement until 3 months post intervention delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety and Depression Measure | 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) | From enrollment until 3 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Emotional Regulation Measure | Improvement in key mediators in the EG compared to the CG at 3 months post intervention. Mediators will include emotional regulation measure through: - The Difficulties in Emotion Regulation Scale Short-Form (values range from 1 to 5, with higher scores indicating worse outcomes) | From enrollement until 3 months post intervention delivery |
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:
Exclusion Criteria:
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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Only females assigned at birth who identify as women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shadi Saleh, PhD, MPH | Contact | +961 3 047 578 | ss117@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Shadi Saleh, PhD | Global Health Institute American University of Beirut | Principal Investigator |
| Lale Say, MD | World Health Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut | Recruiting | Beirut | 00000 | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41547889 | Derived | 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. doi: 10.1186/s13031-026-00748-7. | |
| 41063145 |
| Label | URL |
|---|---|
| This link represents the SEEK trial study page on ELRHA's website. | View source |
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Given the sensitive nature of the topic of this research, IPD will not be shared with other researchers. The studied population represents vulnerable individuals from refugee groups, and so ensuring confidentiality is necessary to keep in line with ethical guidelines and institutional policies, especially that IPD sharing was not communicated to AUB's IRB or to participants enrolled in the trial. Upon publication however, data can be made available as de-identified data to other researchers upon reasonable requests.
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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.
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| General Wellbeing Measure | 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), | From enrollment until the end of 3 months post treatment follow up |
| Self Efficacy Measure | 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) | From enrollment until the end of the intervention at 3 months post treatment |
| Perceived Social Support Measure | 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) | From enrollment until the end of the intervention at 3 months post treatment |
| Interpersonal Communication Measure | Improvement in key mediators in the EG compared to the CG at 3 months post intervention. Mediators will include a communication measure through: - communication using the Interpersonal Communication Competency Scale (values range from 1 to 5, with higher scores indicating better outcomes) | From enrollment until 3 months post intervention |
| Ways of Coping Measure | Improvement in key mediators in the EG compared to the CG at 3 months post intervention. Mediators will include emotional regulation measure through: - coping using the Revised Ways of Coping Checklist (values range from 0 to 3, with higher scores indicating better outcomes) | From enrollment until 3 months post intervention |
| Derived |
| 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. |