Self-efficacy and Knowledge (SEEK) Trial to Improve Sexual Reproductive Health and Well-being for Syrian Refugee Women and Girls in Lebanon

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-15
SponsorAmerican University of Beirut Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • The Self-Efficacy and Knowledge Trial

    Other intervention

    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.

Treatment groups

485 Participants
are divided into 2 treatment groups
Group A: Group receiving SEEK interventionExperimental treatment 1 intervention
Group B: Control group not receiving SEEK interventionNo intervention 0 interventions

Trial outcomes

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.

Time frame
From enrollement until 3 months post intervention delivery

Secondary outcomes

1

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)

Time frame
From enrollment until 3 months post intervention
2

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),

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

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)

Time frame
From enrollment until the end of the intervention at 3 months post treatment
4

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)

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

Other outcomes

1

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)

Time frame
From enrollement until 3 months post intervention delivery
2

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)

Time frame
From enrollment until 3 months post intervention
3

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)

Time frame
From enrollment until 3 months post intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American University of Beirut Medical Center

Lead sponsor

World Health Organization

Collaborator

Elrha

Collaborator