American University of Beirut
Beirut, 00000, Lebanon
Location status: Recruiting
NCT Number: NCT07008950
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.
Interested in participating?
Request Info15 year–15 year
Female
Interventional
Not applicable
Beirut, 00000, Lebanon
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
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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.
Time frame: 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.
Time frame: 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:
Time frame: 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:
Time frame: 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:
Time frame: 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:
Time frame: From enrollement until 3 months post intervention delivery
Improvement in key mediators in the EG compared to the CG at 3 months post intervention. Mediators will include emotional regulation measure through:
Time frame: From enrollment until 3 months post intervention
Improvement in key mediators in the EG compared to the CG at 3 months post intervention. Mediators will include a communication measure through:
Time frame: From enrollment until 3 months post intervention
Improvement in key mediators in the EG compared to the CG at 3 months post intervention. Mediators will include emotional regulation measure through:
Contact information is provided by the study sponsor or research team.
American University of Beirut Medical Center
Other
Acronym: SEEK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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