Community Health Worker Implementation of Transdiagnostic Evidence-based Mental Health Intervention for Spanish-speaking Latine Parents

Официальное название

Community Health Worker Implementation of Transdiagnostic Evidence-based Treatment in Spanish

Обзор

The goal of this clinical trial is to learn if it is doable for community health workers (CHWs) to deliver a mental health intervention to Spanish-speaking Latine parents experiencing anxiety, depression, and/or traumatic stress. The main questions it aims to answer are (1) Is it doable for CHWs to deliver the mental health intervention and for Latine parents to participate in the intervention, and (2) does the CHW-delivered intervention work in reducing Latine parents' mental health symptoms. Researchers will compare Latine parents receiving the intervention to Latine parents not receiving the intervention to see if the CHW-delivered intervention works to improve mental health symptoms. Participants will: * Participate in up to 14 weekly 1-hour sessions of the mental health intervention delivered by a CHW. They will be randomized to receive the intervention immediately or after a 5-month delay. * Participants will complete questionnaires about their symptoms, family and child functioning, as well as about how doable, acceptable, and appropriate they found the intervention * Participants will also complete a recorded interview about their experience in the intervention

Вмешательства

• Поведенческое Common Elements Treatment Approach (CETA)
  CETA is a transdiagnostic evidence-based treatment (EBT) designed to be implemented in low-resource settings and delivered by lay providers with little to no prior mental health training (i.e., CHWs). CETA consists of 11 modules that address the most common mental health disorders, including depression, anxiety, and post-traumatic stress. Modules are based on common elements of EBT, and include topics of psychoeducation, behavioral activation, relaxation, cognitive restructuring, exposures, safe

Первичные конечные точки

• Patient engagement [Срок оценки: Through study completion; over the course of approximately up to 5 months of participant participation]
• Fidelity [Срок оценки: Completed after each CETA session through study completion, over the course of approximately up to 5 months of participant participation]
• Patient intervention retention [Срок оценки: Through study completion; over the course of approximately up to 5 months of participant participation]
• Patient control retention [Срок оценки: Through study completion; over the course of approximately up to 5 months of participant participation]
• Patient assessment completion [Срок оценки: Through study completion; over the course of approximately up to 5 months of participant participation]
• Patient intervention feasibility, acceptability, & appropriateness [Срок оценки: Patients will complete the mhIST immediately after their last intervention session]
• Provider intervention feasibility, acceptability, & appropriateness [Срок оценки: After approximately 2 years of intervention delivery]

Вторичные конечные точки (12)

• Patient mental health symptoms: Baseline [Срок оценки: Baseline pre-randomization]
• Patient mental health symptoms: Monthly [Срок оценки: Completed monthly while receiving the intervention or during the 5-month delay period (depending on randomization assignment)]
• Patient mental health symptoms: Post-intervention [Срок оценки: Completed immediately after the last intervention session]
• Patient mental health symptoms: 1-month post-intervention [Срок оценки: Completed 1 month after the last intervention session]
• Patient mental health symptoms: 3-months post-intervention [Срок оценки: Completed 3 months after the last intervention session]
• Patient quality of life: Baseline [Срок оценки: Baseline pre-randomization]
• Patient quality of life: Post-intervention [Срок оценки: Completed immediately post-intervention]
• Patient quality of life: 1-month post-intervention [Срок оценки: Completed 1 month post-intervention]
• Patient quality of life: 3-month post-intervention [Срок оценки: Completed 3 month post-intervention]
• Parenting stress: Baseline [Срок оценки: Baseline pre-randomization]
• Parenting stress: Post-intervention [Срок оценки: Completed immediately after the last intervention session]
• Parenting stress: 1-month post-intervention [Срок оценки: Completed 1 month after the last intervention session]

Критерии участия

INCLUSION criteria for PATIENT participants are:

• 18 years or older
• Identifies as Latine
• Is a caregiver to a child 18 years or younger old living in the same household
• Preference for Spanish services
• Symptom scores in the moderate range for depression, anxiety, and/or PTSD (based on Computerized Adaptive Tests for Mental Health (CAT-MH))

EXCLUSION criteria for PATIENT participants:

• Presence of mania symptoms in the mild range or higher (based on CAT-MH responses)
• Presence of psychosis symptoms in mild range or higher (based on CAT-MH responses)
• Active suicidal ideation (based on CAT-MH responses)
• Depression, anxiety, or PTSD symptoms in the severe range (based on CAT-MH responses)
• Currently receiving psychotherapy services

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Gustafson EL, Quezada N, Blaisdell KN, Bobadilla G, Stiles-Shields C, McCabe K, Ignoffo S, Kidambi A, Staszko G, Medina B, Smith DL, Barnett M, Anderson EE, Molina Y, Murray L, Becker SJ, Karnik NS. Community health worker implementation of transdiagnostic evidence-based treatment in Spanish: protocol for refinement, implementation, and a feasibility pilot RCT. Implement Sci Commun. 2026 Jun 4. do PMID 42243988

Идентификаторы

NCT: NCT07390630 · 2024-0990 · K08MD020100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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