Family Planning Services, Mental Health Care, Sexual Health Quality of Life
Conditions
Keywords
sexual health, reproductive health, psychosocial support, wellbeing, RCT, Lebanon, Refugees, Girls and young women
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.
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.
Interventions
OTHERThe Self-Efficacy and Knowledge Trial
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.
Sponsors
World Health Organization
Elrha
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
\- 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: 1. are currently married and between the ages of 15 - 24 years, 2. completed an average stay in Lebanon for a minimum of 6 months, 3. 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, 4. have none of the
Exclusion criteria
listed below upon screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Family Planning Use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Wellbeing Measure | 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: \- general wellbeing using the World Health Organization-5 questionnaire (values range from 0 to 5 per question with higher scores indicating better outcomes), |
| Anxiety and Depression Measure | 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: \- anxiety and depression using the Hopkins Symptom Checklist-25 (values range from 1 to 4 per question with higher scores indicating worse outcomes) |
| Self Efficacy Measure | 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: \- 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 | 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: \- 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
| Measure | Time frame | Description |
|---|---|---|
| Ways of Coping Measure | 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: \- coping using the Revised Ways of Coping Checklist (values range from 0 to 3, with higher scores indicating better outcomes) |
| Interpersonal Communication Measure | 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: \- communication using the Interpersonal Communication Competency Scale (values range from 1 to 5, with higher scores indicating better outcomes) |
| Emotional Regulation Measure | 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: \- The Difficulties in Emotion Regulation Scale Short-Form (values range from 1 to 5, with higher scores indicating worse outcomes) |
Countries
Lebanon
Contacts
Primary ContactShadi Saleh, PhD, MPH
Outcome results
None listed