NCT07008950

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
485

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

February 28, 2025

Last Update Submit

June 5, 2025

Conditions

Mental Health CareSexual Health Quality of LifeFamily Planning Services

Keywords

sexual healthreproductive healthpsychosocial supportwellbeingRCTLebanonRefugeesGirls and young women

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Anxiety and Depression Measure

    From enrollment until 3 months post intervention

  • General Wellbeing Measure

    From enrollment until the end of 3 months post treatment follow up

  • Self Efficacy Measure

    From enrollment until the end of the intervention at 3 months post treatment

  • Perceived Social Support Measure

    From enrollment until the end of the intervention at 3 months post treatment

Other Outcomes (3)

  • Emotional Regulation Measure

    From enrollement until 3 months post intervention delivery

  • Interpersonal Communication Measure

    From enrollment until 3 months post intervention

  • Ways of Coping Measure

    From enrollment until 3 months post intervention

Study Arms (2)

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.

Other: The Self-Efficacy and Knowledge Trial

Control group not receiving SEEK intervention

NO INTERVENTION

Interventions

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.

Group receiving SEEK intervention

Eligibility Criteria

Age15 Years - 15 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females assigned at birth who identify as women
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, 00000, Lebanon

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41063145DERIVED

Related Links

Study Officials

  • Shadi Saleh, PhD

    Global Health Institute American University of Beirut

    PRINCIPAL INVESTIGATOR

  • Lale Say, MD

    World Health Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shadi Saleh, PhD, MPH

CONTACT

+961 3 047 578ss117@aub.edu.lb

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Founding Director of the Global Health Institute

Study Record Dates

First Submitted

February 28, 2025

First Posted

June 6, 2025

Study Start

January 1, 2024

Primary Completion

May 1, 2025

Study Completion

June 30, 2025

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

LE(1)