About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
The Self-Efficacy and Knowledge Trial
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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)
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),
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)
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)
Other outcomes
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)
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)
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)
Sponsors and contacts
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American University of Beirut Medical Center
Lead sponsor
World Health Organization
Collaborator
Elrha
Collaborator