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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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.
Patient engagement
Number of intervention sessions completed per patient
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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."
Time frame: 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."
Time frame: After approximately 2 years of intervention delivery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Completed 3 months after the last intervention session