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

University of Illinois

Status: Begins enrollment in 11 months

Conditions: Traumatic Stress; Depression; Anxiety

Treatments: Behavioral: Common Elements Treatment Approach (CETA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07390630

K08MD020100 (U.S. NIH Grant/Contract)

2024-0990

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Immediate CETA

Experimental group

Description:

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

Treatment:

Behavioral: Common Elements Treatment Approach (CETA)

Delayed CETA

No Intervention group

Description:

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.