NCT07390630

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

Not yet recruiting NA Last updated 28 January 2026

What this trial tests

NA trial testing Common Elements Treatment Approach (CETA) in Depression in 52 participants. Not yet recruiting.

Timeline

1 February 2027

Primary endpoint
1 January 2029

1 March 2029

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	1 February 2027
Primary completion	1 January 2029
Estimated completion	1 March 2029

Drugs / interventions tested

• Common Elements Treatment Approach (CETA)

Conditions studied

• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →
• Traumatic Stress — all drugs for Traumatic Stress →

Sponsor

University of Illinois at Chicago

Who can join

18 and older, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Patient engagement
  Time frame: Through study completion; over the course of approximately up to 5 months of participant participation
  Number of intervention sessions completed per patient
• Fidelity
  Time frame: Completed after each CETA session through study completion, over the course of approximately up to 5 months of participant participation
  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
• Patient intervention retention
  Time frame: Through study completion; over the course of approximately up to 5 months of participant participation
  Number of patients who begin the intervention and go on to complete the intervention
• Patient control retention
  Time frame: Through study completion; over the course of approximately up to 5 months of participant participation
  Number of participants assigned to the control condition who remain enrolled at the end of the 5-month delay period
• Patient assessment completion
  Time frame: Through study completion; over the course of approximately up to 5 months of participant participation
  Proportion of planned assessments that are completed by patients
• Patient intervention feasibility, acceptability, & appropriateness
  Time frame: Patients will complete the mhIST immediately after their last intervention session
  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."

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Community health worker implementation of transdiagnostic evidence-based treatment in Spanish: protocol for refinement, implementation, and a feasibility pilot RCT.
   Gustafson EL, Quezada N, Blaisdell KN, Bobadilla G, et al · · 2026 · PMID 42243988 · DOI 10.1186/s43058-026-00980-5