Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women
2022年4月29日 更新者：India Ornelas、University of Washington
ALMA: A Randomized Control Trial of an Intervention to Reduce Mental Health Disparities in Mexican Immigrant Women
Latina immigrant women are particularly vulnerable to depression and anxiety due to the social and economic stressors they face, including high levels of poverty, low levels of education, family obligations, exposure to violence, and limited access to community resources.
ALMA aims to prevent and reduce depression and anxiety among Latina immigrant women.
Women attend 8 weekly sessions in a group format to teach and encourage women to use coping strategies to reduce depression and anxiety.
The intervention aims to increase participants' social ties and the social support they receive from other Latina immigrant women.
The program also helps decrease the stigma associated with mental health and connects women to mental health services when needed.
調査の概要
詳細な説明
The proposed study aims to test the efficacy of the Amigas Latinas Motivando el Alma (ALMA) intervention in a randomized control trial.
ALMA is an 8-week program offered in a group format to teach women new coping strategies and enhance their social ties and social support to prevent and reduce their depression and anxiety.
Aim 1 of the proposed study is to refine the ALMA intervention and study procedures, using information learned from focus groups and cognitive interviews with Mexican immigrant women.
Aim 2 is to determine the efficacy of the ALMA intervention to reduce depressive and anxiety symptoms using a randomized control study design.
We will recruit women from community-based organizations serving Latino immigrants to participate in the program, which will be offered in community settings.
We will assess process outcomes of recruitment, retention, fidelity, and participant satisfaction through observations and in-depth interviews with participants.
We will assess the efficacy of the intervention by comparing changes in women's depressive and anxiety symptoms in the intervention and attention control groups at four time points (pre-intervention, post-intervention, 6 months, 9 months).
Aim 3 is to assess the potential impact of the intervention on both individual (stigma, stress, coping strategies) and interpersonal (social support, social ties) factors, and whether the impact of the intervention is mediated by these factors.
The research team includes investigators in psychology, medicine, social work and public health, as well as community-based organizations serving Latina immigrants.
The study uses rigorous methods to test an innovative program that integrates both culturally relevant and evidenced-based strategies to address significant mental health disparities in a high-risk and underserved population.
Findings will help inform future research and practice.
Given the growth of the Latino population, identifying interventions that reduce mental health disparities among Mexican immigrant women can have a significant public health impact.
研究の種類
介入
入学 (実際)
226
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Washington
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Seattle、Washington、アメリカ、98144
- Casa Latina
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Seattle、Washington、アメリカ、98144
- El Centro de la Raza
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- To be eligible for study participation, participants must be at least 18 years of age, female, speak Spanish, must self-identify as Latina, and have been born outside of the United States.
Exclusion Criteria:
- Participant screened for high levels of depressive symptoms (as indicated by a score of 20 or higher on the PHQ-9) which indicates severe symptoms. Participants with scores above 20 were referred to the licensed mental health counselor on the study team. If these women are not already receiving mental health treatment, they will be referred to mental health providers offering low-cost services in Spanish. The counselor will discuss participation in the program with the potential participants and make the final determination about their ability to participate based on the care they are currently receiving and the severity of their symptoms.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：非ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：ALMA Intervention Group
Amigas Latinas Motivando el Alma (ALMA).
This group receives the intervention after baseline assessment.
|
In a series of 8 weekly sessions, the program uses a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. Over the course of the eight ALMA sessions, 25 women are (1) engaged in activities to identify coping strategies they are currently using and encouraged to continue to use them; (2) introduced to new coping strategies (e.g. mindfulness techniques, increased social ties and social support); and, (3) provided resources for seeking additional help if needed. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
|
他の：ALMA Delayed Intervention Control Group
Amigas Latinas Motivando el Alma (ALMA).
This group receives the intervention five months after the baseline assessment (after the post-intervention, and 3 month assessments have been completed).
|
In a series of 8 weekly sessions, the program uses a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. Over the course of the eight ALMA sessions, 25 women are (1) engaged in activities to identify coping strategies they are currently using and encouraged to continue to use them; (2) introduced to new coping strategies (e.g. mindfulness techniques, increased social ties and social support); and, (3) provided resources for seeking additional help if needed. Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions. |
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 |
|---|---|---|
|
Depressive Symptoms
時間枠：Change measure (baseline, 4 months, 6 months, 9 months)
|
Frequency of depressive symptoms as measured by the Patient Health Questionnaire 9 in the last two weeks.
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
Scores range from 0 to 27.
In general, a total of 10 or above is suggestive of the presence of depression.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
|
Change measure (baseline, 4 months, 6 months, 9 months)
|
|
Anxiety Symptoms
時間枠：Change measure (baseline, 4 months, 6 months, 9 months)
|
Frequency of anxiety symptoms as measured by the General Anxiety Disorders 7 in the last two weeks.
Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).
Scores range from 0 to 21. Scores ≥10.
Anxiety Severity: 1-4 minimal symptoms, 5-9 mild symptoms, 10-14 moderate symptoms, 15-21 severe symptoms
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Change measure (baseline, 4 months, 6 months, 9 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ストレス
時間枠：変化の目安（ベースライン、4ヶ月、6ヶ月、9ヶ月）
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先月に感じられたストレスの頻度。
知覚ストレス スケール (PSS) は、古典的なストレス評価手段です。
PSS の個々のスコアは 0 から 40 の範囲であり、スコアが高いほど、知覚されるストレスが高いことを示します。
0 ～ 13 の範囲のスコアは、低ストレスとみなされます。
14 ～ 26 のスコアは中程度のストレスとみなされます。
27 ～ 40 の範囲のスコアは、知覚されるストレスが高いとみなされます。
|
変化の目安（ベースライン、4ヶ月、6ヶ月、9ヶ月）
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment
時間枠：Baseline
|
Number of participants that are recruited to participate in the study
|
Baseline
|
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Retention
時間枠：First 9 months after enrollment
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Number of participant that complete study procedures, including intervention sessions and surveys.
Satisfactory retention is defined as 80% of participants complete survey and 75% attending at least half of the intervention sessions.
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First 9 months after enrollment
|
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Participant Satisfaction
時間枠：4 months, 9 months
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Survey items related to program logistics such as convenience for participants, perception of facilitators, connection with other participants, and perceived efficacy of the intervention.
Response options of 1 - 5, with 5 indicating highest satisfaction
|
4 months, 9 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：India J Ornelas, PhD, MPH、University of Washington
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年3月7日
一次修了 (実際)
2021年12月15日
研究の完了 (実際)
2022年1月1日
試験登録日
最初に提出
2018年5月11日
QC基準を満たした最初の提出物
2018年5月22日
最初の投稿 (実際)
2018年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月5日
QC基準を満たした最後の更新が送信されました
2022年4月29日
最終確認日
2022年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- STUDY00003331
- R01MD012230 (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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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