Clinical trial NCT03978533: Low Intensity Family Support for Refugees in an LMIC
Official title: Low Intensity Family Support for Refugees in an LMIC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
PTSD
Family Dynamics
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2019-06-07
Enrollment: 189
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The rapidly growing scale of humanitarian crises requires new response capabilities geared towards addressing populations with prolonged high vulnerability to mental health consequences and little to no access to mental health, health, and social resources. This R21 develops and pilot tests a novel model for helping urban refugee families in LMICs with little to no access to evidence-based mental health services, by delivering a transdiagnostic family intervention for common mental disorders in health sector and non-health sector settings. The project is located in Istanbul, Turkey. Aim 1 forms a Family Support Design Team (FSDT) to adopt the PM+ and CAFES manuals into a family support (FS) intervention for use with refugee families by lay providers in community sites and nurses in clinical sites using a four-session multiple family group format. Aim 2 pilots FS with families in community and clinical sites, and then through observations and qualitative interviews, assesses FS's feasibility, fidelity, the impact of context and local capacity, the experiences of intervention delivery, and practitioner and organizational perspectives on scale up. Aim 3 conducts pre, immediate post, and 3-month post assessments of the refugee families who received FS through all the sites, to demonstrate the kind of pre-post changes that have been reported for comparable interventions and to determine key parameters of interest with sufficient accuracy and precision. This exploratory investigation, conducted with the support and advice of the World Health Organization, will strengthen the research capabilities of the academic and community partners in Istanbul and will develop new evidence-based mental health services for refugees in Turkey and other LMICs, as well as for refugees and migrants in low resource communities in the United States.

Detailed description: RATIONALE The rapidly growing scale of global humanitarian crises requires new response capabilities geared towards addressing populations with prolonged high vulnerability to mental health consequences and little access to health and social resources. The World Health Organization (WHO), under the leadership of Dr. Mark van Ommeren, has been advocating for low resource-intensity cognitive behavioral therapy (LICBT) for such conditions. They conducted two large RCTs of Problem Management Plus (PM+), a brief, basic, one-on-one, paraprofessional-delivered version of LICBT for adults, which demonstrated clinically significant reductions in anxiety and depressive symptoms at 3 months. LICBT could help to address some needs among Syrian refugees, but our recent D43 supported longitudinal study of 30 Syrian refugee families in Istanbul, found that one key challenge is its fit with the strong family context of Syrians. The investigators found evidence of families with adult and/or children with CMD symptoms and challenges managing stress, but also evidence of family strengths and resilience, and families facing multiple adverse challenges. In August 2017, Dr. Weine met with Dr. van Ommeren at the WHO, and they agreed to work in partnership to extend the WHO's LICBT approach to families. In September 2017, Weine et al convened a roundtable with key stakeholders in Istanbul, which reached a consensus about the need for a new family intervention that included elements of PM+ but also of family interventions, for delivery in a group format. Specifically, the investigators chose to incorporate elements of Coffee and Families Education and Support (CAFES), a NIMH funded family support and education intervention that the investigators previously developed and evaluated with refugee families from Bosnia and Kosovo. Other key implementation challenges are who will conduct the intervention, what training do they require, what organizational capacity is required, and how to best integrate FS into community and clinical sites.

AIM 1 To form a Family Support Design Team (FSDT) to adopt the PM+ and CAFES manuals into a family support (FS) intervention for use with Syrian refugee families by lay providers in community sites and nurses in clinical sites using a four-session multiple family group format.

AIM 2 To pilot FS with families in community and clinical sites, and then through observations and qualitative interviews, to assess FS's feasibility, fidelity, the impact of context and local capacity, the experiences of intervention delivery, and practitioner and organizational perspectives on scale up.

AIM 3 To conduct pre, immediate post, and 3-month post assessments of the Syrian refugee families who received FS through all the sites, to demonstrate the kind of pre-post changes that have been reported for comparable interventions and to determine key parameters of interest with sufficient accuracy and precision.

Eligibility criteria: Inclusion Criteria:

* Syrian refugee family living in Istanbul
* contains both adult caregivers (18-55) and at least one of their children (\<18 and \>11 years) living in one household
* one adult or adolescent with \> 3 on the GHQ-12
* willing to participate in the intervention and research procedures
* able to give written informed consent

Exclusion Criteria:

• Families who do no have a child \<18 and \>11 years old

Primary outcomes:
measure: Change from baseline of Strengths and Difficulties Questionnaire at immediate post and three months post intervention
timeFrame: baseline, immediate post, three months post
measure: Change from baseline of Kansas Parental Satisfaction Scale at immediate post and three months post intervention
timeFrame: baseline, immediate post, three months post
measure: Change from baseline of PTSD Checklist for DSM-5 at immediate post and three months post intervention
timeFrame: baseline, immediate post, three months post
measure: Change from baseline Hospital Anxiety Depression Scale at immediate post and three months post intervention
timeFrame: baseline, immediate post, three months post
measure: Change from baseline General Health Questionnaire at immediate post and three month post intervention
timeFrame: baseline, immediate post, three months post
Secondary outcomes:
measure: Change from baseline Family Communication Questionnaire at immediate post and three month post intervention
timeFrame: baseline, immediate post, three months post
measure: Change in baseline Knowledge and Attitudes Regarding Trauma Mental Health Questionnaire at immediate post and three month post intervention
timeFrame: baseline, immediate post, three months post
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Can Association
city: Istanbul
country: Turkey
facility: Hiraeth
city: Istanbul
country: Turkey
facility: Insan for Psychosocial Support
city: Istanbul
country: Turkey
facility: Syrian Nour Association
city: Istanbul
country: Turkey
facility: Turkish Red Crescent
city: Istanbul
country: Turkey
facility: Yusra Community Center
Study officials:
affiliation: University of Illinois at Chicago
name: Stevan Weine, MD
role: PRINCIPAL_INVESTIGATOR
References: