LMICにおける難民に対する低強度の家族支援
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Istanbul、トルコ（Türkiye）
- Can Association
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Istanbul、トルコ（Türkiye）
- Hiraeth
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Istanbul、トルコ（Türkiye）
- Insan for Psychosocial Support
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Istanbul、トルコ（Türkiye）
- Syrian Nour Association
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Istanbul、トルコ（Türkiye）
- Turkish Red Crescent
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Istanbul、トルコ（Türkiye）
- Yusra Community Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Family Support Group
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 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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PTSD Checklist for DSM-5 (Adult Participants)
時間枠：baseline, immediate post, three months post
|
PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A total score of 31-33 or higher generally indicates probable PTSD, with 0-80 as the total range.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=0," "A little bit=1" Moderately=2" "Quite a bit=3" and "Extremely=4." Summing all 20 items (range 0-80) provides a total severity score and using a cut-point score of 31-33 appears to be reasonable based upon current psychometric work. The higher the score, the more severe. |
baseline, immediate post, three months post
|
|
General Health Questionnaire (GHQ-12)
時間枠：baseline, immediate post, three months post
|
The 12-Item General Health Questionnaire (GHQ-12) (Goldberg & Williams, 1988) consists of 12 items, each one assessing the severity of a mental problem over the past few weeks using a 4-point Likert-type scale (from 0 to 3). The score was used to generate a total score ranging from 0 to 36, higher scores indicating poorer mental health and higher severity of distress. |
baseline, immediate post, three months post
|
|
Child and Adolescent Trauma Screen (CATS) (for Adolescent Participants)
時間枠：baseline, immediate post, 3 month post
|
The CATS is a screening instrument for posttraumatic stress symptoms (PTSS) in children and adolescents. The measure consists of 20 items assessing symptoms across the four DSM-5-defined clusters: re-experiencing, avoidance, negative mood and cognitive changes, and hyperarousal. Each item is rated on a four-point scale (0=never; 1=sometimes; 2=often; 3=almost always) reflecting both symptom frequency and intensity. For participants aged 7 to 17, a composite symptom score is derived by adding the scores of all items, resulting in a total score range 0 to 60. Higher scores= a worse outcome. Scoring: 0-14= not elevated; 15-20 mild/moderate trauma-related distress; 21 or grater= elevated distress, positive screening threshold; 25 or greater= high trauma-related distress, probably PTSD. Recommend to use a cut-off ≥ 21 as indication of a clinically relevant level of symptoms. |
baseline, immediate post, 3 month post
|
協力者と研究者
捜査官
- 主任研究者：Stevan Weine, MD、University of Illinois Chicago
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2018-0547
- R21MH117759 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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