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

NCT07390630 | Not Yet Recruiting

• 2 other identifiers: 2024-0990K08MD020100
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depression; Anxiety; Traumatic Stress

Keywords

community health workers; implementation science; feasibility; parent mental health

Outcome Measures

Primary Outcomes (7)

• Patient engagement

  Number of intervention sessions completed per patient

  Through study completion; over the course of approximately up to 5 months of participant participation

• Fidelity

  CETA Fidelity Monitory System: Session information is documented by the CETA provider, who is trained to document what they did in each session relating to specific steps outlined in each CETA element. Each element in the CETA manual is executed through detailed "steps". Fidelity includes what CETA elements are chosen, when they are delivered, steps completed within each element, and the frequency in which each element is delivered.

  Completed after each CETA session through study completion, over the course of approximately up to 5 months of participant participation

• Patient intervention retention

  Number of patients who begin the intervention and go on to complete the intervention

  Through study completion; over the course of approximately up to 5 months of participant participation

• Patient control retention

  Number of participants assigned to the control condition who remain enrolled at the end of the 5-month delay period

  Through study completion; over the course of approximately up to 5 months of participant participation

• Patient assessment completion

  Proportion of planned assessments that are completed by patients

  Through study completion; over the course of approximately up to 5 months of participant participation

• Patient intervention feasibility, acceptability, & appropriateness

  The Mental Health Implementation Science Tools (mhIST), consumer version measures domains of acceptability, appropriateness, and feasibility via self-report by those receiving an intervention. The mhIST uses a four-point Likert scale with the options of "Not at all," "A little bit," "A moderate amount," and "A lot."

  Patients will complete the mhIST immediately after their last intervention session

• Provider intervention feasibility, acceptability, & appropriateness

  The Mental Health Implementation Science Tools (mhIST), provider version measures domains of acceptability, appropriateness, and feasibility via self-report by those delivering an intervention. The mhIST uses a four-point Likert scale with the options of "Not at all," "A little bit," "A moderate amount," and "A lot."

  After approximately 2 years of intervention delivery

Secondary Outcomes (21)

• Patient mental health symptoms: Baseline

  Baseline pre-randomization

• Patient mental health symptoms: Monthly

  Completed monthly while receiving the intervention or during the 5-month delay period (depending on randomization assignment)

• Patient mental health symptoms: Post-intervention

  Completed immediately after the last intervention session

• Patient mental health symptoms: 1-month post-intervention

  Completed 1 month after the last intervention session

• Patient mental health symptoms: 3-months post-intervention

  Completed 3 months after the last intervention session

Study Arms (2)

Immediate CETA

EXPERIMENTAL

Participants will participate in up to 14 weekly 1-hour CETA sessions with a community health worker provider

Behavioral: Common Elements Treatment Approach (CETA)

Delayed CETA

NO INTERVENTION

Participants will receive no treatment during a 5-month period while completing symptom measures mirroring those in the active treatment condition. After the delay, participants will be able to receive the treatment.

Interventions

Common Elements Treatment Approach (CETA) BEHAVIORAL

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, safety planning, and substance use reduction. Designed with non-specialists in mind, CETA materials follow a simple, concrete format, with a 1-5 page "manual" section and 1-2 page "steps sheet" for each module that includes goals, example wording, and guidance for in-session use during implementation. CETA has demonstrated effectiveness in RCTs around the world, but has yet to be examined in the US in the context of CHW implementation.

Also known as: CETA

Immediate CETA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Sinai Urban Health Institute: collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Erika L Gustafson, PhD

CONTACT

312-355-0626; gustafs6@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 5, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: April 2029 to March 2034
• Access Criteria: Data will be uploaded to an institutional repository that is open to the general public.