DepressionNCT07390630
Community Health Worker Implementation of Transdiagnostic Evidence-based Mental Health Intervention for Spanish-speaking Latine Parents
A study testing Common Elements Treatment Approach (CETA) in people with Depression and Anxiety, run by University of Illinois Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Traumatic Stress
- What is being tested?
- Common Elements Treatment Approach (CETA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Community Health Worker Implementation of Transdiagnostic Evidence-based Treatment in Spanish
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.
Read more
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
- Conditions
- Depression, Anxiety, Traumatic Stress
- Being tested
- Common Elements Treatment Approach (CETA)
- Keywords
- community health workers, implementation science, feasibility, parent mental health
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common Elements Treatment Approach (CETA)Behavioural
Also called CETA
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate CETA | Experimental | Participants will participate in up to 14 weekly 1-hour CETA sessions with a community health worker provider Receives: Behavioral: Common Elements Treatment Approach (CETA) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient engagement
Number of intervention sessions completed per patient
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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."
Measured: 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."
Measured: After approximately 2 years of intervention delivery
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Completed 3 months after the last intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startFeb 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Sinai Urban Health Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390630
- Sponsor's protocol ID
- 2024-0990
- Other IDs
- K08MD020100
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 42243988
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker Implementation of Transdiagnostic Evidence-based Treatment in Spanish
- ClinicalTrials.gov ID
- NCT07390630
- Acronym / sponsor ID
- 2024-0990
- Conditions
- Depression, Anxiety, Traumatic Stress
- Keywords
- community health workers, implementation science, feasibility, parent mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Sinai Urban Health Institute
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate CETA | Experimental | Behavioral: Common Elements Treatment Approach (CETA)Participants will participate in up to 14 weekly 1-hour CETA sessions with a community health worker provider |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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))
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common Elements Treatment Approach (CETA)Also: CETACETA 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. | Behavioural | Immediate CETA |
Primary outcome
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."
21 secondary outcomes
Patient mental health symptoms: Baseline
Time frame: Baseline pre-randomization
Patient mental health symptoms: Monthly
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
Time frame: Completed immediately after the last intervention session
Patient mental health symptoms: 1-month post-intervention
Time frame: Completed 1 month after the last intervention session
Patient mental health symptoms: 3-months post-intervention
Time frame: Completed 3 months after the last intervention session
Patient quality of life: Baseline
Time frame: Baseline pre-randomization
Patient quality of life: Post-intervention
Time frame: Completed immediately post-intervention
Patient quality of life: 1-month post-intervention
Time frame: Completed 1 month post-intervention
Patient quality of life: 3-month post-intervention
Time frame: Completed 3 month post-intervention
Parenting stress: Baseline
Time frame: Baseline pre-randomization
Parenting stress: Post-intervention
Time frame: Completed immediately after the last intervention session
Parenting stress: 1-month post-intervention
Time frame: Completed 1 month after the last intervention session
Parenting stress: 3-month post-intervention
Time frame: Completed 3 months after the last intervention session
Child mental health: Baseline
Time frame: Baseline pre-randomization
Child mental health: Post-intervention
Time frame: Completed immediately after the last intervention session
Child mental health: 1-month post-intervention
Time frame: Completed 1 month after the last intervention session
Child mental health: 3-month post-intervention
Time frame: Completed 3 months after the last intervention session
Family functioning: Baseline
Time frame: Baseline pre-randomization
Family functioning: Post-intervention
Time frame: Completed immediately after the last intervention session
Family functioning: 1-month post-intervention
Time frame: Completed 1 month after the last intervention session
Family functioning: 3-month post-intervention
Time frame: Completed 3 months after the last intervention session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 42243988Gustafson 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Common Elements Treatment Approach (CETA) in people with Depression and Anxiety, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika L Gustafson, PhD (312-355-0626, gustafs6@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient engagement (time frame: Through study completion; over the course of approximately up to 5 months of participant participation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07390630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.