ParentsNCT07360600
ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics
A study testing ACT Together in people with Parents and Children With Disabilities, run by University of South Florida at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parents, Children With Disabilities, Stress
- What is being tested?
- ACT Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to Dec 2026
- 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
- Community-dwelling adults (aged ≥18 years) with primary caregiving responsibility for a child with disabilities (aged <18 years) who is enrolled in a participating clinic;
- Expected to use services at the participating clinic at least once per week over the next three months;
- Willing to learn strategies to cope with emotions and thoughts; and
- Have access to a web-enabled device (e.g., smartphone, tablet, laptop, or desktop) with reliable internet access at home or in a public space (e.g., library).
- Be willing to participate in training, program implementation, and study evaluations; and
- Currently work in a pediatric clinic that serves at least 15 children who attend the clinic at least once per week.
Who cannot join
- Cognitive, physical, sensory impairments, or language barriers (non-English speaking) that would impede participation;
- Suicidal intent or suicide attempt(s) within the past six months;
- Participation in another parent support research study at the time of recruitment; or
- More than three hospitalizations of either the parent or child within the past year, or other serious health concerns that would interfere with program engagement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Areum Han, PhD, 813-396-0524, areumhan@usf.edu
Jeremy Jenkins, MS, 813-396-0524, jeremyjenkins@usf.edu
About this study
The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them.
The main questions this study aims to answer are:
Read more
- Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)?
- Is the program usable and acceptable/appropriate/feasible to implement in this setting?
- Do parents show improvements in mental health and coping-related outcomes after participating in the program?
- What are the experiences and perspectives of parents and therapists regarding the program?
Parents as participants will:
- Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics.
- Complete online questionnaires before starting and after completing the program.
- Take part in one online interview about their experiences and perspectives on the program.
Occupational therapists as participants will:
- Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist.
- Complete brief online questionnaires before starting and after delivering the program.
- Take part in one online interview about their experiences and perspectives on the program.
Read the detailed description
Parents of children with disabilities often experience elevated psychological distress and may face barriers to accessing timely, evidence-based support. ACT Together is a research-developed program designed to support parents' coping and psychological well-being in a scalable format that can be implemented in pediatric outpatient clinic settings. This study will be a one-group, pretest-posttest mixed-methods pilot to evaluate the feasibility and implementation of ACT Together when delivered as (1) six self-paced, web-based acceptance and commitment therapy (ACT) modules and (2) six brief phone coaching provided by occupational therapists working in pediatric outpatient clinics. All study activities will be coordinated by the University of South Florida (USF) and will be completed remotely using secure online platforms; coaching sessions will be delivered by phone.
Occupational therapists will be recruited via a study flyer and will complete an online screening process. Eligible therapists will complete electronic informed consent and baseline questionnaires and will then access therapist-specific training materials in Canvas. Parents of children with disabilities will be recruited through clinic-based flyer dissemination (e.g., posting or placing flyers at reception). Interested parents will contact the study team and will complete online screening. Eligible parents will complete electronic informed consent and baseline questionnaires and will then receive access to the parent Canvas course.
ACT Together will include six self-paced, weekly web-based ACT modules and six brief coaching sessions (approximately 15-20 minutes each) delivered after each module by a trained occupational therapist. The modules will be hosted on the USF Canvas platform. Two separate Canvas courses will be used: a parent course that includes ACT modules and activities for parents, and a therapist course that includes training materials and structured coaching guidance to support delivery of the brief coaching sessions. Coaching sessions will use structured questions and guidance developed for research purposes and are not intended as standard clinical care. Coaching sessions will be conducted by phone at a mutually agreed time between the parent and the participating occupational therapist. Occupational therapists will complete a brief session checklist in Qualtrics after each coaching session to document that required components were delivered; these checklists will be used to calculate session-level coaching fidelity.
Parents will be encouraged to complete approximately one module per week and to participate in a coaching session after each module over approximately 7-8 weeks. Both parents and occupational therapists will complete questionnaires at pretest and posttest. Parent-reported outcomes will include depressive symptoms, anxiety, perceived stress, psychological quality of life, and ACT-related processes (psychological inflexibility, cognitive fusion, and values-based engagement). Posttest implementation measures will capture perceived usability, acceptability, appropriateness, and feasibility (reported separately by parents and therapists).
Both groups will complete a one-time individual interview at posttest to understand user experiences and implementation perspectives and to inform refinement of the program and study procedures. Post-program interviews will be conducted via the HIPAA-compliant version of Microsoft Teams and will be audio recorded. Interviews are expected to last approximately 40 minutes.
The Canvas course will capture program engagement metrics (e.g., logins, time spent, and module completion) and responses to in-program activities for research purposes. Occupational therapist checklists completed after each coaching session will provide implementation documentation and fidelity indicators. Feasibility indicators will include enrollment rate, retention, and adherence (completion of modules and coaching sessions).
All data will be collected electronically using university-approved secure platforms (Qualtrics, the ACT Together program hosted on USF Canvas, and HIPAA-compliant Microsoft Teams). ACT Together will not be publicly available and will be accessible only to enrolled participants using study-specific login credentials. Identifying information will be collected only as needed for study operations (e.g., communication and compensation) and will be stored separately from research data. Study data will be stored in secure, access-controlled USF systems (including USF Box), with access restricted to authorized study personnel. Only de-identified, aggregate results will be used for dissemination.
- Conditions
- Parents, Children With Disabilities, Stress, Depression
- Being tested
- ACT Together
- Keywords
- Acceptance and Commitment Therapy, web-based intervention, internet-based intervention, occupational therapist, parents, children with disabilities, depressive symptoms, stress, feasibility, acceptability, usability, implementation, mixed methods, Pilot Study, phone coaching
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT TogetherBehavioural
ACT Together includes six self-paced, weekly web-based ACT modules and six brief phone coaching sessions delivered after each module by a trained occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | The ACT group will complete the ACT Together program. Receives: Behavioral: ACT Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
The enrollment rate will be calculated as the number of participants who consent and complete the baseline evaluation divided by the number of participants who are eligible and invited to participate in the study.
Measured: During the recruitment period (up to approximately 6 months)
Retention
Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment.
Measured: Baseline through post-intervention (approximately 7-8 weeks)
Web-based module completion
Web-based module completion will be defined as the number of web-based modules completed (range 0-6 modules).
Measured: Baseline through post-intervention (approximately 7-8 weeks)
Coaching session completion
Coaching session completion will be defined as the number of coaching sessions completed (range 0-6 sessions).
Measured: Baseline through post-intervention (approximately 7-8 weeks)
Secondary outcomes (12)
Usability
Usability will be assessed using the System Usability Scale (SUS; 10 items rated 1 = strongly disagree to 5 = strongly agree; total score 0-100).
Measured: Post-intervention (approximately 7-8 weeks)
Acceptability of the program
Acceptability of the program will be assessed using the Acceptability of Intervention Measure (AIM). AIM includes 4 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scale scores will be calculated and reported separately for parents and therapists.
Measured: Post-intervention (approximately 7-8 weeks)
Appropriateness of the program
Appropriateness will be assessed using the Intervention Appropriateness Measure (IAM). IAM includes 4 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scale scores will be calculated and reported separately for parents and therapists.
Measured: Post-intervention (approximately 7-8 weeks)
Feasibility of the program
Feasibility of the program will be assessed using the Feasibility of Intervention Measure (FIM). FIM includes 4 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scale scores will be calculated and reported separately for parents and therapists.
Measured: Post-intervention (approximately 7-8 weeks).
Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention
PHQ-9 is a nine-item self-report questionnaire assessing depressive symptoms over the past two weeks, rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline to post-intervention (approximately 7-8 weeks)
Change in Generalized Anxiety Disorder -7 (GAD-7) scores from baseline to post-intervention
GAD-7 is a seven-item self-report questionnaire assessing anxiety symptoms over the past two weeks, rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores reflecting greater anxiety symptoms.
Measured: Baseline to post-intervention (approximately 7-8 weeks)
Change in Perceived Stress Scale-10 (PSS-10) scores from baseline to post-intervention
PSS-10 is a 10-item questionnaire assessing perceived stress. Items are rated from 0 to 4. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Measured: Baseline to post-intervention (approximately 7-8 weeks)
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Psychological Health domain scores from baseline to post-intervention
The WHOQOL-BREF Psychological Health domain includes 6 items rated from 1 to 5. Domain scores will be calculated and reported as transformed scores on a 0-100 scale, with higher scores indicating better psychological quality of life.
Measured: Baseline to post-intervention (approximately 7-8 weeks)
Change in Brief Experiential Avoidance Questionnaire (BEAQ) scores from baseline to post-intervention
BEAQ is a15-item self-report measure of experiential avoidance on a scale of 1 to 6. Total scores range from 15 to 90, with higher scores indicating greater experiential avoidance.
Measured: Baseline to post-intervention (approximately 7-8 weeks)
Change in Cognitive Fusion Questionnaire-7 (CFQ-7) scores from baseline to post-intervention
CFQ-7 is a 7-item self-report questionnaire measuring cognitive fusion. Items are rated from 1 to 7. Total scores range from 7 to 49, with higher scores indicating a higher degree of cognitive fusion.
Measured: Baseline to post-intervention (approximately 7-8 weeks)
Change in Engaged Living Scale-9 (ELS-9) scores from baseline to post-intervention
ELS-9 is a 9-item self-assessment instrument measuring clarity and engagement with personal values. Items are rated from 1 to 5. Total scores range from 9 to 45, with higher scores indicating increased clarity and engagement with personal values.
Measured: Baseline to post-intervention (approximately 7-8 weeks)
Change in Multidimensional Psychological Flexibility Inventory-24 (MPFI-24) scores from baseline to post-intervention
MPFI-24 is a 24-item self-report measure of multidimensional psychological flexibility and inflexibility processes on a scale of 1 to 6. Higher subscale or composite scores indicate greater psychological flexibility or inflexibility.
Measured: Baseline to post-intervention (approximately 7-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start18 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Areum Han, University of South Florida
- Investigators
- Areum Han, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360600
- Sponsor's protocol ID
- STUDY009450
- Other IDs
- AOTFIR24Han
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics
- ClinicalTrials.gov ID
- NCT07360600
- Acronym / sponsor ID
- STUDY009450
- Conditions
- Parents, Children With Disabilities, Stress, Depression
- Keywords
- Acceptance and Commitment Therapy, web-based intervention, internet-based intervention, occupational therapist, parents, children with disabilities, depressive symptoms, stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jan 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 evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them.
The main questions this study aims to answer are:
- Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)?
- Is the program usable and acceptable/appropriate/feasible to implement in this setting?
- Do parents show improvements in mental health and coping-related outcomes after participating in the program?
- What are the experiences and perspectives of parents and therapists regarding the program?
Parents as participants will:
- Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics.
- Complete online questionnaires before starting and after completing the program.
- Take part in one online interview about their experiences and perspectives on the program.
Occupational therapists as participants will:
- Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist.
- Complete brief online questionnaires before starting and after delivering the program.
- Take part in one online interview about their experiences and perspectives on the program.
Detailed description
Parents of children with disabilities often experience elevated psychological distress and may face barriers to accessing timely, evidence-based support. ACT Together is a research-developed program designed to support parents' coping and psychological well-being in a scalable format that can be implemented in pediatric outpatient clinic settings. This study will be a one-group, pretest-posttest mixed-methods pilot to evaluate the feasibility and implementation of ACT Together when delivered as (1) six self-paced, web-based acceptance and commitment therapy (ACT) modules and (2) six brief phone coaching provided by occupational therapists working in pediatric outpatient clinics. All study activities will be coordinated by the University of South Florida (USF) and will be completed remotely using secure online platforms; coaching sessions will be delivered by phone.
Occupational therapists will be recruited via a study flyer and will complete an online screening process. Eligible therapists will complete electronic informed consent and baseline questionnaires and will then access therapist-specific training materials in Canvas. Parents of children with disabilities will be recruited through clinic-based flyer dissemination (e.g., posting or placing flyers at reception). Interested parents will contact the study team and will complete online screening. Eligible parents will complete electronic informed consent and baseline questionnaires and will then receive access to the parent Canvas course.
ACT Together will include six self-paced, weekly web-based ACT modules and six brief coaching sessions (approximately 15-20 minutes each) delivered after each module by a trained occupational therapist. The modules will be hosted on the USF Canvas platform. Two separate Canvas courses will be used: a parent course that includes ACT modules and activities for parents, and a therapist course that includes training materials and structured coaching guidance to support delivery of the brief coaching sessions. Coaching sessions will use structured questions and guidance developed for research purposes and are not intended as standard clinical care. Coaching sessions will be conducted by phone at a mutually agreed time between the parent and the participating occupational therapist. Occupational therapists will complete a brief session checklist in Qualtrics after each coaching session to document that required components were delivered; these checklists will be used to calculate session-level coaching fidelity.
Parents will be encouraged to complete approximately one module per week and to participate in a coaching session after each module over approximately 7-8 weeks. Both parents and occupational therapists will complete questionnaires at pretest and posttest. Parent-reported outcomes will include depressive symptoms, anxiety, perceived stress, psychological quality of life, and ACT-related processes (psychological inflexibility, cognitive fusion, and values-based engagement). Posttest implementation measures will capture perceived usability, acceptability, appropriateness, and feasibility (reported separately by parents and therapists).
Both groups will complete a one-time individual interview at posttest to understand user experiences and implementation perspectives and to inform refinement of the program and study procedures. Post-program interviews will be conducted via the HIPAA-compliant version of Microsoft Teams and will be audio recorded. Interviews are expected to last approximately 40 minutes.
The Canvas course will capture program engagement metrics (e.g., logins, time spent, and module completion) and responses to in-program activities for research purposes. Occupational therapist checklists completed after each coaching session will provide implementation documentation and fidelity indicators. Feasibility indicators will include enrollment rate, retention, and adherence (completion of modules and coaching sessions).
All data will be collected electronically using university-approved secure platforms (Qualtrics, the ACT Together program hosted on USF Canvas, and HIPAA-compliant Microsoft Teams). ACT Together will not be publicly available and will be accessible only to enrolled participants using study-specific login credentials. Identifying information will be collected only as needed for study operations (e.g., communication and compensation) and will be stored separately from research data. Study data will be stored in secure, access-controlled USF systems (including USF Box), with access restricted to authorized study personnel. Only de-identified, aggregate results will be used for dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | Behavioral: ACT TogetherThe ACT group will complete the ACT Together program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Community-dwelling adults (aged ≥18 years) with primary caregiving responsibility for a child with disabilities (aged <18 years) who is enrolled in a participating clinic;
- Expected to use services at the participating clinic at least once per week over the next three months;
- Willing to learn strategies to cope with emotions and thoughts; and
- Have access to a web-enabled device (e.g., smartphone, tablet, laptop, or desktop) with reliable internet access at home or in a public space (e.g., library).
- Be willing to participate in training, program implementation, and study evaluations; and
Key exclusion criteria (4 listed)
- Cognitive, physical, sensory impairments, or language barriers (non-English speaking) that would impede participation;
- Suicidal intent or suicide attempt(s) within the past six months;
- Participation in another parent support research study at the time of recruitment; or
- More than three hospitalizations of either the parent or child within the past year, or other serious health concerns that would interfere with program engagement.
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 |
|---|---|---|
| ACT TogetherACT Together includes six self-paced, weekly web-based ACT modules and six brief phone coaching sessions delivered after each module by a trained occupational therapist. | Behavioural | Acceptance and commitment therapy (ACT) group |
Primary outcome
Enrollment rate
Time frame: During the recruitment period (up to approximately 6 months)
The enrollment rate will be calculated as the number of participants who consent and complete the baseline evaluation divided by the number of participants who are eligible and invited to participate in the study.
Retention
Time frame: Baseline through post-intervention (approximately 7-8 weeks)
Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment.
Web-based module completion
Time frame: Baseline through post-intervention (approximately 7-8 weeks)
Web-based module completion will be defined as the number of web-based modules completed (range 0-6 modules).
Coaching session completion
Time frame: Baseline through post-intervention (approximately 7-8 weeks)
Coaching session completion will be defined as the number of coaching sessions completed (range 0-6 sessions).
12 secondary outcomes
Usability
Time frame: Post-intervention (approximately 7-8 weeks)
Acceptability of the program
Time frame: Post-intervention (approximately 7-8 weeks)
Appropriateness of the program
Time frame: Post-intervention (approximately 7-8 weeks)
Feasibility of the program
Time frame: Post-intervention (approximately 7-8 weeks).
Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 7-8 weeks)
Change in Generalized Anxiety Disorder -7 (GAD-7) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 7-8 weeks)
Change in Perceived Stress Scale-10 (PSS-10) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 7-8 weeks)
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Psychological Health domain scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 7-8 weeks)
Change in Brief Experiential Avoidance Questionnaire (BEAQ) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 7-8 weeks)
Change in Cognitive Fusion Questionnaire-7 (CFQ-7) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 7-8 weeks)
Change in Engaged Living Scale-9 (ELS-9) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 7-8 weeks)
Change in Multidimensional Psychological Flexibility Inventory-24 (MPFI-24) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 7-8 weeks)
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Areum Han, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Together in people with Parents and Children With Disabilities, run by University of South Florida at 1 site in United States.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Areum Han, PhD (813-396-0524, areumhan@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: During the recruitment period (up to approximately 6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.