Anxiety, Depression, Traumatic Stress
Conditions
Keywords
community health workers, implementation science, feasibility, parent mental health
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
Interventions
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.
Sponsors
University of Illinois at Chicago
National Institute on Minority Health and Health Disparities (NIMHD)
Sinai Urban Health Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient engagement | Through study completion; over the course of approximately up to 5 months of participant participation | Number of intervention sessions completed per patient |
| Fidelity | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient mental health symptoms: Baseline | Baseline pre-randomization | 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. |
| Patient mental health symptoms: Monthly | Completed monthly while receiving the intervention or during the 5-month delay period (depending on randomization assignment) | 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. |
| Patient mental health symptoms: Post-intervention | Completed immediately after the last intervention session | 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. |
| Patient mental health symptoms: 1-month post-intervention | Completed 1 month after the last intervention session | 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. |
| Patient mental health symptoms: 3-months post-intervention | Completed 3 months after the last intervention session | 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. |
| Patient quality of life: Baseline | Baseline pre-randomization | 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. |
| Patient quality of life: Post-intervention | Completed immediately 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. |
| Patient quality of life: 1-month post-intervention | Completed 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. |
| Patient quality of life: 3-month post-intervention | Completed 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. |
| Parenting stress: Baseline | Baseline pre-randomization | 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 |
| Parenting stress: Post-intervention | Completed immediately after the last intervention session | 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 |
| Parenting stress: 1-month post-intervention | Completed 1 month after the last intervention session | 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 |
| Parenting stress: 3-month post-intervention | Completed 3 months after the last intervention session | 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 |
| Child mental health: Baseline | Baseline pre-randomization | 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). |
| Child mental health: Post-intervention | Completed immediately after the last intervention session | 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). |
| Child mental health: 1-month post-intervention | Completed 1 month after the last intervention session | 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). |
| Child mental health: 3-month post-intervention | Completed 3 months after the last intervention session | 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). |
| Family functioning: Baseline | Baseline pre-randomization | 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) |
| Family functioning: Post-intervention | Completed immediately after the last intervention session | 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) |
| Family functioning: 1-month post-intervention | Completed 1 month after the last intervention session | 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) |
| Family functioning: 3-month post-intervention | Completed 3 months after the last intervention session | 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) |
Contacts
CONTACTErika L Gustafson, PhD
Outcome results
None listed