Low Intensity Family Support for Refugees in an LMIC

NCT03978533 | Completed

• 2 other identifiers: 2018-0547R21MH117759
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 6

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.

Conditions

Depression; Anxiety; PTSD; Family Dynamics

Outcome Measures

Primary Outcomes (5)

• Change from baseline of Strengths and Difficulties Questionnaire at immediate post and three months post intervention

  Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire about 3-16 year olds. For this project, the adolescent version will be used for ages 11-17. The questionnaire comprises 5 scales of 5 items each. Total difficulties score: This is generated by summing scores from all the scales except the prosocial scale. Scoring is close to average; slightly raised (/slightly lowered); high (/low); very high (very low) Total difficulties score: 0-14; 15-17; 18-19; 20-40 Emotional problems score: 0-4; 5; 6; 7-10 Conduct problems score: 0-3; 4; 5; 6-10 Hyperactivity score: 0-5; 6; 7; 8-10 Peer problems score: 0-2; 3; 4; 5-10 Prosocial score:7-10; 6; 5; 0-4

  baseline, immediate post, three months post

• Change from baseline of Kansas Parental Satisfaction Scale at immediate post and three months post intervention

  Kansas Parental Satisfaction Scale (KPSS) asks three questions about their satisfaction with a) their children's behavior, b) them as a parent, and c) their relationship with their children. The instrument uses a 7-point Likert scale with response choices ranging from 1 ("extremely dissatisfied") to 7 ("extremely satisfied"). The scores for all three items are summed to yield a total parenting satisfaction score. Scores range from 3 - 21. Scores of 15 or less indicate low parental satisfaction.

  baseline, immediate post, three months post

• Change from baseline of PTSD Checklist for DSM-5 at immediate post and three months post intervention

  PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment; Screening individuals for PTSD; Making a provisional PTSD diagnosis. The PCL-5 is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study. It takes approximately 5-10 minutes to complete.The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." Treating each item rated as 2 = "Moderately" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (questions 1-5), 1 Criterion C item (questions 6-7), 2 Criterion D items (questions 8-14), 2 Criterion E items (questions 15-20).

  baseline, immediate post, three months post

• Change from baseline Hospital Anxiety Depression Scale at immediate post and three months post intervention

  HADS (Hospital Anxiety and Depression Scale) aims to measure symptoms of anxiety (HADS Anxiety) and depression (HADS Depression).The HADS is a fourteen item scale; seven of the items relate to anxiety and seven relate to depression. Each question is scored 0-3, a person can score between 0 and 21 for either anxiety or depression. For both scales of depression or anxiety, a score of 0-7 is normal, 8-10 is mild, 11-14 is moderate, and 15-21 is severe.

  baseline, immediate post, three months post

• Change from baseline General Health Questionnaire at immediate post and three month post intervention

  General Health Questionnaire (GHQ-12) is a screening device for identifying minor psychiatric disorders in the general population. The GHQ-12 is a quick, reliable and sensitive short form that is ideal for research studies. The GHQ-12 yields an overall total score. The GHQ scoring is 0-0-1-1, with a score range from 0-12. Any score exceeding the threshold value of 3 as achieving 'caseness'.

  baseline, immediate post, three months post

Secondary Outcomes (2)

• Change from baseline Family Communication Questionnaire at immediate post and three month post intervention

  baseline, immediate post, three months post

• Change in baseline Knowledge and Attitudes Regarding Trauma Mental Health Questionnaire at immediate post and three month post intervention

  baseline, immediate post, three months post

Study Arms (1)

Family Support Group

EXPERIMENTAL

Family Support Groups will be piloted with families in community and clinical sites. Each pair of facilitators will pilot two groups of 6 families each. Each group is 4 sessions lasting 2 hours each. Each of the sessions incorporates didactic talks, family discussion, and separate breakout groups for adolescents and adults. Family Support intervention incorporates cognitive-behavioral theory of PM+ which underlies evidence-based techniques focused on stress management and behavioral activation. Family support intervention also incorporates resilience theory, which explains family protective processes that can ameliorate the negative consequences of hardships and challenges and enable healing and growth in families.

Behavioral: Family Support Group

Interventions

Family Support Group BEHAVIORAL

Family Support Groups will be piloted with families in community and clinical sites. Each pair of facilitators will pilot two groups of 6 families each. Each group is 4 sessions lasting 2 hours each. Each of the sessions incorporates didactic talks, family discussion, and separate breakout groups for adolescents and adults. Family Support intervention incorporates cognitive-behavioral theory of PM+ which underlies evidence-based techniques focused on stress management and behavioral activation. Family support intervention also incorporates resilience theory, which explains family protective processes that can ameliorate the negative consequences of hardships and challenges and enable healing and growth in families.

Family Support Group

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (6)

Can Association

Istanbul, Turkey (Türkiye)

Location

Hiraeth

Istanbul, Turkey (Türkiye)

Location

Insan for Psychosocial Support

Istanbul, Turkey (Türkiye)

Location

Syrian Nour Association

Istanbul, Turkey (Türkiye)

Location

Turkish Red Crescent

Istanbul, Turkey (Türkiye)

Location

Yusra Community Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Stevan Weine, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 7, 2019
• Study Start: August 16, 2019
• Primary Completion: February 28, 2021
• Study Completion: July 15, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (6)