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

Official title

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

Overview

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

Interventions

• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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

Identifiers

NCT: NCT07390630 · 2024-0990 · K08MD020100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗