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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Common Elements Treatment Approach (CETA)
BehavioralCETA 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
Trial outcomes
Primary outcomes
Patient engagement
Number of intervention sessions completed per patient
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.
Patient intervention retention
Number of patients who begin the intervention and go on to complete the intervention
Patient control retention
Number of participants assigned to the control condition who remain enrolled at the end of the 5-month delay period
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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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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