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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Traumatic Stress
• Intervention / Treatment: Behavioral: Common Elements Treatment Approach (CETA)

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erika L Gustafson, PhD; Phone Number: 312-355-0626; Email: gustafs6@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate CETA; Participants will participate in up to 14 weekly 1-hour CETA sessions with a community health worker provider	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, 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.; Other Names: CETA
No Intervention: Delayed CETA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline pre-randomization
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.	Completed monthly while receiving the intervention or during the 5-month delay period (depending on randomization assignment)
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.	Completed immediately after the last intervention session
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.	Completed 1 month after the last intervention session
Patient mental health symptoms: 3-months 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.	Completed 3 months after the last intervention session
Patient quality of life: Baseline	World Health Organization Quality of Life - Abbreviated version (WHOQOL-BREF): patient-report of quality of life across domains of physical health, psychological health, social relationships, and environment, using a 5-point likert scale.	Baseline pre-randomization
Patient quality of life: Post-intervention	World Health Organization Quality of Life - Abbreviated version (WHOQOL-BREF): patient-report of quality of life across domains of physical health, psychological health, social relationships, and environment, using a 5-point likert scale.	Completed immediately post-intervention
Patient quality of life: 1-month post-intervention	World Health Organization Quality of Life - Abbreviated version (WHOQOL-BREF): patient-report of quality of life across domains of physical health, psychological health, social relationships, and environment, using a 5-point likert scale.	Completed 1 month post-intervention
Patient quality of life: 3-month post-intervention	World Health Organization Quality of Life - Abbreviated version (WHOQOL-BREF): patient-report of quality of life across domains of physical health, psychological health, social relationships, and environment, using a 5-point likert scale.	Completed 3 month post-intervention
Parenting stress: Baseline	Parental Stress Scale (PSS): patient-report of parenting stress across three scales -- parental distress, parent-child dysfunctional interaction, and difficult child -- using a 1 (strongly disagree) - 5 (strongly agree) likert scale	Baseline pre-randomization
Parenting stress: Post-intervention	Parental Stress Scale (PSS): patient-report of parenting stress across three scales -- parental distress, parent-child dysfunctional interaction, and difficult child -- using a 1 (strongly disagree) - 5 (strongly agree) likert scale	Completed immediately after the last intervention session
Parenting stress: 1-month post-intervention	Parental Stress Scale (PSS): patient-report of parenting stress across three scales -- parental distress, parent-child dysfunctional interaction, and difficult child -- using a 1 (strongly disagree) - 5 (strongly agree) likert scale	Completed 1 month after the last intervention session
Parenting stress: 3-month post-intervention	Parental Stress Scale (PSS): patient-report of parenting stress across three scales -- parental distress, parent-child dysfunctional interaction, and difficult child -- using a 1 (strongly disagree) - 5 (strongly agree) likert scale	Completed 3 months after the last intervention session
Child mental health: Baseline	Strengths and Difficulties Questionnaire (SDQ): Patient-report of child's behavioral functioning across five scales (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships; and prosocial behaviors) for each of their children using a 3-point likert scale (not true, somewhat true, & certainly true).	Baseline pre-randomization
Child mental health: Post-intervention	Strengths and Difficulties Questionnaire (SDQ): Patient-report of child's behavioral functioning across five scales (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships; and prosocial behaviors) for each of their children using a 3-point likert scale (not true, somewhat true, & certainly true).	Completed immediately after the last intervention session
Child mental health: 1-month post-intervention	Strengths and Difficulties Questionnaire (SDQ): Patient-report of child's behavioral functioning across five scales (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships; and prosocial behaviors) for each of their children using a 3-point likert scale (not true, somewhat true, & certainly true).	Completed 1 month after the last intervention session
Child mental health: 3-month post-intervention	Strengths and Difficulties Questionnaire (SDQ): Patient-report of child's behavioral functioning across five scales (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships; and prosocial behaviors) for each of their children using a 3-point likert scale (not true, somewhat true, & certainly true).	Completed 3 months after the last intervention session
Family functioning: Baseline	Family Relations Scale: participant-report of family functioning across three scales -- family cohesion, support, and organization -- using a 4-point likert scale (1: not true at all - 4: almost always or always true)	Baseline pre-randomization
Family functioning: Post-intervention	Family Relations Scale: patient-report of family functioning across three scales -- family cohesion, support, and organization -- using a 4-point likert scale (1: not true at all - 4: almost always or always true)	Completed immediately after the last intervention session
Family functioning: 1-month post-intervention	Family Relations Scale: patient-report of family functioning across three scales -- family cohesion, support, and organization -- using a 4-point likert scale (1: not true at all - 4: almost always or always true)	Completed 1 month after the last intervention session
Family functioning: 3-month post-intervention	Family Relations Scale: patient-report of family functioning across three scales -- family cohesion, support, and organization -- using a 4-point likert scale (1: not true at all - 4: almost always or always true)	Completed 3 months after the last intervention session

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Sinai Urban Health Institute

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: feasibility; implementation science; community health workers; parent mental health
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression
• Other Study ID Numbers: 2024-0990; K08MD020100 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified datasets containing quantitative questionnaire data from patient participants will be made available via an open institutional repository. Specific de-identified data elements will include demographic, administrative (condition assignment, attendance, fidelity), clinical (symptom questionnaires about mental health, well being, family, and child functioning), and implementation (intervention acceptability, feasibility) data.
• IPD Sharing Time Frame: April 2029 to March 2034
• IPD Sharing Access Criteria: Data will be uploaded to an institutional repository that is open to the general public.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No