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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Immediate CETAExperimental treatment 1 intervention
Group B: Delayed CETANo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Patient engagement

Number of intervention sessions completed per patient

Time frame
Through study completion; over the course of approximately up to 5 months of participant participation
2

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.

Time frame
Completed after each CETA session through study completion, over the course of approximately up to 5 months of participant participation
3

Patient intervention retention

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

Time frame
Through study completion; over the course of approximately up to 5 months of participant participation
4

Patient control retention

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

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

Secondary outcomes

1

Patient mental health symptoms: Baseline

Computerized Adaptive Testing (CAT) for Mental Health (CAT-MH): The CAT-MH is a suite of multidimensional item response theory (IRT) based CATs for the dimensional measurement of symptoms of depression, anxiety, and PTSD, amongst others. The CAT-MH generates a score and accompanying severity band for each disorder module based on patient report.

Time frame
Baseline pre-randomization
2

Patient mental health symptoms: Monthly

Computerized Adaptive Testing (CAT) for Mental Health (CAT-MH): The CAT-MH is a suite of multidimensional item response theory (IRT) based CATs for the dimensional measurement of symptoms of depression, anxiety, and PTSD, amongst others. The CAT-MH generates a score and accompanying severity band for each disorder module based on patient report.

Time frame
Completed monthly while receiving the intervention or during the 5-month delay period (depending on randomization assignment)
3

Patient mental health symptoms: Post-intervention

Computerized Adaptive Testing (CAT) for Mental Health (CAT-MH): The CAT-MH is a suite of multidimensional item response theory (IRT) based CATs for the dimensional measurement of symptoms of depression, anxiety, and PTSD, amongst others. The CAT-MH generates a score and accompanying severity band for each disorder module based on patient report.

Time frame
Completed immediately after the last intervention session
4

Patient mental health symptoms: 1-month post-intervention

Computerized Adaptive Testing (CAT) for Mental Health (CAT-MH): The CAT-MH is a suite of multidimensional item response theory (IRT) based CATs for the dimensional measurement of symptoms of depression, anxiety, and PTSD, amongst others. The CAT-MH generates a score and accompanying severity band for each disorder module based on patient report.

Time frame
Completed 1 month after the last intervention session

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Sinai Urban Health Institute

Collaborator

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