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NCT Number: NCT07390630

Community Health Worker Implementation of Transdiagnostic Evidence-based Mental Health Intervention for Spanish-speaking Latine Parents

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

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Traumatic Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CETA

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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."

  7. 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

  1. Patient mental health symptoms: Baseline

    Time frame: 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.

  2. Patient mental health symptoms: Monthly

    Time frame: 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.

  3. Patient mental health symptoms: Post-intervention

    Time frame: 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.

  4. Patient mental health symptoms: 1-month post-intervention

    Time frame: 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.

  5. Patient mental health symptoms: 3-months post-intervention

    Time frame: 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.

  6. Patient quality of life: Baseline

    Time frame: 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.

  7. Patient quality of life: Post-intervention

    Time frame: 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.

  8. Patient quality of life: 1-month post-intervention

    Time frame: 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.

  9. Patient quality of life: 3-month post-intervention

    Time frame: 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.

  10. Parenting stress: Baseline

    Time frame: 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

  11. Parenting stress: Post-intervention

    Time frame: 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

  12. Parenting stress: 1-month post-intervention

    Time frame: 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

  13. Parenting stress: 3-month post-intervention

    Time frame: 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

  14. Child mental health: Baseline

    Time frame: 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).

  15. Child mental health: Post-intervention

    Time frame: 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).

  16. Child mental health: 1-month post-intervention

    Time frame: 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).

  17. Child mental health: 3-month post-intervention

    Time frame: 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).

  18. Family functioning: Baseline

    Time frame: 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)

  19. Family functioning: Post-intervention

    Time frame: 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)

  20. Family functioning: 1-month post-intervention

    Time frame: 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)

  21. Family functioning: 3-month post-intervention

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Erika L Gustafson, PhD

CONTACT

[email protected]

312-355-0626

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Sinai Urban Health Institute

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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