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| ID | Type | Description | Link |
|---|---|---|---|
| K08MD020100 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Sinai Urban Health Institute | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate CETA | Experimental | Participants will participate in up to 14 weekly 1-hour CETA sessions with a community health worker provider |
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| Delayed CETA | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Common Elements Treatment Approach (CETA) | Behavioral | 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. |
| 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 |
| 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 |
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INCLUSION criteria for PATIENT participants are:
EXCLUSION criteria for PATIENT participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erika L Gustafson, PhD | Contact | 312-355-0626 | gustafs6@uic.edu |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42243988 | Derived | Gustafson EL, Quezada N, Blaisdell KN, Bobadilla G, Stiles-Shields C, McCabe K, Ignoffo S, Kidambi A, Staszko G, Medina B, Smith DL, Barnett M, Anderson EE, Molina Y, Murray L, Becker SJ, Karnik NS. Community health worker implementation of transdiagnostic evidence-based treatment in Spanish: protocol for refinement, implementation, and a feasibility pilot RCT. Implement Sci Commun. 2026 Jun 4. doi: 10.1186/s43058-026-00980-5. Online ahead of print. |
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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.
April 2029 to March 2034
Data will be uploaded to an institutional repository that is open to the general public.
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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 |
| 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 |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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