Intervention Trial to Reduce Mental Health Disparities in Latina Immigrant Women
29 avril 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
226
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Washington
-
Seattle, Washington, États-Unis, 98144
- Casa Latina
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Seattle, Washington, États-Unis, 98144
- El Centro de la Raza
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Autre: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Depressive Symptoms
Délai: 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
Délai: 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
|
Change measure (baseline, 4 months, 6 months, 9 months)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Stress
Délai: Mesure du changement (baseline, 4 mois, 6 mois, 9 mois)
|
Fréquence du stress perçu au cours du dernier mois.
L'échelle de stress perçu (PSS) est un instrument classique d'évaluation du stress.
Les scores individuels sur le PSS peuvent aller de 0 à 40, les scores les plus élevés indiquant un stress perçu plus élevé.
Des scores allant de 0 à 13 seraient considérés comme un niveau de stress faible.
Des scores allant de 14 à 26 seraient considérés comme un stress modéré.
Des scores allant de 27 à 40 seraient considérés comme un stress perçu élevé.
|
Mesure du changement (baseline, 4 mois, 6 mois, 9 mois)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment
Délai: Baseline
|
Number of participants that are recruited to participate in the study
|
Baseline
|
|
Retention
Délai: First 9 months after enrollment
|
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.
|
First 9 months after enrollment
|
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Participant Satisfaction
Délai: 4 months, 9 months
|
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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: India J Ornelas, PhD, MPH, University of Washington
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
7 mars 2018
Achèvement primaire (Réel)
15 décembre 2021
Achèvement de l'étude (Réel)
1 janvier 2022
Dates d'inscription aux études
Première soumission
11 mai 2018
Première soumission répondant aux critères de contrôle qualité
22 mai 2018
Première publication (Réel)
4 juin 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 avril 2022
Dernière vérification
1 avril 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00003331
- R01MD012230 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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