Mental Health CareSEEKNCT07008950
Self-efficacy and Knowledge (SEEK) Trial to Improve Sexual Reproductive Health and Well-being for Syrian Refugee Women and Girls in Lebanon
A study testing The Self-Efficacy and Knowledge Trial in people with Mental Health Care and Sexual Health Quality of Life, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Care, Sexual Health Quality of Life, Family Planning Services
- What is being tested?
- The Self-Efficacy and Knowledge Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- -
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut
Beirut, 00000
Shadi Saleh, PhD, +961 3 047 578, ss117@aub.edu.lb
About this study
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.
Read the 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.
- Being tested
- The Self-Efficacy and Knowledge Trial
- Keywords
- sexual health, reproductive health, psychosocial support, wellbeing, RCT, Lebanon, Refugees, Girls and young women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Self-Efficacy and Knowledge TrialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The Self-Efficacy and Knowledge Trial |
| Control group not receiving SEEK intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollement until 3 months post intervention delivery
Secondary outcomes (4)
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)
Measured: From enrollment until 3 months post intervention
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),
Measured: 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)
Measured: 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)
Measured: From enrollment until the end of the intervention at 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jan 2024
- Primary completion1 May 2025
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Elrha
- Responsible party
- Principal investigator, Shadi Saleh, American University of Beirut Medical Center
- Investigators
- Shadi Saleh, PhD, Principal investigator, Global Health Institute American University of BeirutLale Say, MD, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008950
- Sponsor's protocol ID
- SBS-2023-0310
- Other IDs
- 78689
- Acronym
- SEEK
- Status last verified
- Jun 2025
- First submitted
- 28 Feb 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Kobeissi L, Ibrahim S, Abdul Sater Z, Bosqui T, Honein-AbouHaidar G, Farhat T, Mohammad Fouad MF, Naal H, Hudroj L, Sarieddine D, Govender V, Say L, Hamadeh R, Saleh S. Self-efficacy and knowledge trial to improve sexual reproductive health and well-being for Syrian refugee women and girls in Lebanon: a study protocol for a randomized community-based trial. Front Glob Womens Health. 2026 Aug 6;7:1793696. doi: 10.3389/fgwh.2026.1793696. eCollection 2026.
PubMed 42625874Saleh 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.
PubMed 41547889Sarieddine 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.
PubMed 41063145
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-efficacy and Knowledge (SEEK) Trial to Improve Sexual Reproductive Health and Well-being for Syrian Refugee Women and Girls in Lebanon
- ClinicalTrials.gov ID
- NCT07008950
- Acronym / sponsor ID
- SEEK / SBS-2023-0310
- Keywords
- sexual health, reproductive health, psychosocial support, wellbeing, RCT, Lebanon, Refugees, Girls and young women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 485 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- World Health Organization, Elrha
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group receiving SEEK intervention | Experimental | Other: The Self-Efficacy and Knowledge TrialParticipants 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. |
| Control group not receiving SEEK intervention | No intervention | – |
Who may qualify
- Ages
- 15 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- -
- 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,
Key exclusion criteria (5 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Self-Efficacy and Knowledge TrialThe 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. | Other | Group receiving SEEK intervention |
Primary outcome
Family Planning Use
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.
4 secondary outcomes
Anxiety and Depression Measure
Time frame: From enrollment until 3 months post intervention
General Wellbeing Measure
Time frame: From enrollment until the end of 3 months post treatment follow up
Self Efficacy Measure
Time frame: From enrollment until the end of the intervention at 3 months post treatment
Perceived Social Support Measure
Time frame: From enrollment until the end of the intervention at 3 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 42625874Kobeissi L, Ibrahim S, Abdul Sater Z, Bosqui T, Honein-AbouHaidar G, Farhat T, Mohammad Fouad MF, Naal H, Hudroj L, Sarieddine D, Govender V, Say L, Hamadeh R, Saleh S. Self-efficacy and knowledge trial to improve sexual reproductive health and well-being for Syrian refugee women and girls in Lebanon: a study protocol for a randomized community-based trial. Front Glob Womens Health. 2026 Aug 6;7:1793696. doi: 10.3389/fgwh.2026.1793696. eCollection 2026.
- Derived from this study: PubMed 41547889Saleh 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.
- Derived from this study: PubMed 41063145Sarieddine 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.
- This link represents the SEEK trial study page on ELRHA's website.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shadi Saleh, PhD principal investigator
Global Health Institute American University of Beirut
Lale Say, MD principal investigator
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Self-Efficacy and Knowledge Trial in people with Mental Health Care and Sexual Health Quality of Life, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shadi Saleh, PhD, MPH (+961 3 047 578, ss117@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Planning Use (time frame: From enrollement until 3 months post intervention delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07008950, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.