Community Health Worker Implementation of Transdiagnostic Evidence-based Treatment in Spanish
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 52
- Primary Endpoint
- Patient engagement
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Immediate CETA
Participants will participate in up to 14 weekly 1-hour CETA sessions with a community health worker provider
Intervention: Common Elements Treatment Approach (CETA) (Behavioral)
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.
Outcomes
Primary Outcomes
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 in which each element is delivered.
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."
Provider intervention feasibility, acceptability, & appropriateness
Time Frame: After approximately 2 years of intervention delivery
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."
Secondary Outcomes
- Patient mental health symptoms: Baseline(Baseline pre-randomization)
- Patient mental health symptoms: Monthly(Completed monthly while receiving the intervention or during the 5-month delay period (depending on randomization assignment))
- Patient mental health symptoms: Post-intervention(Completed immediately after the last intervention session)
- Patient quality of life: Baseline(Baseline pre-randomization)
- Patient mental health symptoms: 1-month post-intervention(Completed 1 month after the last intervention session)
- Patient mental health symptoms: 3-months post-intervention(Completed 3 months after the last intervention session)
- Patient quality of life: Post-intervention(Completed immediately post-intervention)
- Patient quality of life: 1-month post-intervention(Completed 1 month post-intervention)
- Patient quality of life: 3-month post-intervention(Completed 3 month post-intervention)
- Parenting stress: Baseline(Baseline pre-randomization)
- Parenting stress: Post-intervention(Completed immediately after the last intervention session)
- Parenting stress: 1-month post-intervention(Completed 1 month after the last intervention session)
- Parenting stress: 3-month post-intervention(Completed 3 months after the last intervention session)
- Child mental health: Baseline(Baseline pre-randomization)
- Child mental health: Post-intervention(Completed immediately after the last intervention session)
- Child mental health: 1-month post-intervention(Completed 1 month after the last intervention session)
- Child mental health: 3-month post-intervention(Completed 3 months after the last intervention session)
- Family functioning: Baseline(Baseline pre-randomization)
- Family functioning: Post-intervention(Completed immediately after the last intervention session)
- Family functioning: 1-month post-intervention(Completed 1 month after the last intervention session)
- Family functioning: 3-month post-intervention(Completed 3 months after the last intervention session)