Family CaregiversNCT07876206
Pilot Trial of a Meaning And Problem-Solving (MAPS) Intervention for Family Caregivers of Children With Medical Complexity
A study testing MAPS (Meaning And Problem Solving) and Usual Psychosocial Care in people with Family Caregivers and Children With Medical Complexity (CMC), run by University of Pittsburgh at 1 site in United States.
Trial summary
This study aims to evaluate a new program specifically developed to better support parents and family caregivers of children with complex health needs. The name of this program is MAPS (Meaning and Problem Solving). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Caregivers, Children With Medical Complexity (CMC)
- What is being tested?
- MAPS (Meaning And Problem Solving) and Usual Psychosocial Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 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
- Family caregiver of a child or dependent adult with impaired capacity receiving medical care at UPMC Children's Hospital of Pittsburgh's Complex Care Center or from UPMC Children's Hospital of Pittsburgh's Supportive Care team.
- Caregiver has medical decision-making authority for their child (as determined by the clinical attending physician).
- Caregiver's child is medically complex, which is defined as 1+ chronic health conditions, major functional limitations, significant health service needs, and high health care utilization.
Who cannot join
- Caregiver is <18 years of age.
- Caregiver does not have medical decision-making authority (e.g., grandparent accompanying child to appointment).
- Caregiver unable to complete intervention sessions in English.
- Caregivers of children who do not live at home (i.e., reside in long-term nursing care facilities).
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
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Justin Yu, MD, MSc, 2157388265, yuja@upmc.edu
Roxanne Jones, jonesrk2@upmc.edu
About this study
Official title: Feasibility and Acceptability Pilot Randomized Controlled Trial of a Meaning-Centered Problem-Solving Therapy Intervention for Family Caregivers of Children With Medical Complexity
This study aims to evaluate a new program specifically developed to better support parents and family caregivers of children with complex health needs. The name of this program is MAPS (Meaning and Problem Solving). The goal of MAPS is to improve caregivers' emotional well-being and confidence in dealing with adversity. The investigators are testing the program to see if parent and family caregiver participants find the MAPS program acceptable and to identify ways the investigators can improve it.
Read the detailed description
The goal of this pilot study is to evaluate whether conducting a randomized clinical trial of a novel psychological intervention, entitled MAPS, specifically designed for family caregivers of children with medical complexity, is feasible and acceptable. The investigators will compare participation in the MAPS program to usual psychosocial care. Family caregiver participants randomized to the MAPS intervention will participate in 8 one-on-one virtual sessions with a trained MAPS facilitator over 2-3 months, and complete a pre- and post-intervention survey questionnaire, as well as an exit interview.
- Being tested
- MAPS (Meaning And Problem Solving), Usual Psychosocial Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAPS (Meaning And Problem Solving)Behavioural
The MAPS intervention is a manualized behavioral program, tailored for family caregivers of children with medical complexity, which consists of 8 one-on-one 45-60 minute sessions delivered by a trained interventionist. The intervention aims to improve participant mental health and emotional well-being by enhancing participants' sense of meaning and problem-solving skills.
Key components adapted from meaning-centered psychotherapy include: identifying sources of meaning, guided imagery, personalized coping statements, meaningful activity scheduling, and values-based goal setting. Problem-solving skills-training is adapted from Bright IDEAS, a 5-step framework to teach problem-solving skills originally developed for mothers of children with cancer. Participants receive a workbook with reference materials, worksheets, and home practice exercises to promote skill mastery and routine maintenance.
Usual Psychosocial CareBehavioural
Participants randomized to the comparison arm will receive usual psychosocial care services routinely provided by our institution's pediatric complex care and palliative care interdisciplinary team. This psychosocial care includes routine clinical evaluations, emotional and social support, and care coordination services, which are delivered via scheduled outpatient clinic visits, phone/virtual consultations, or inpatient visits.
| Study group | Role | What they receive |
|---|---|---|
| MAPS Intervention | Experimental | Participants randomized to this experimental arm will undergo 8 one-on-one sessions with a trained MAPS interventionist over 2-3 months. Sessions can be conducted in-person or via videoconference (per participant preference); and will last 45- to 60-minutes in duration. Receives: Behavioral: MAPS (Meaning And Problem Solving) |
| Usual Psychosocial Care | Active comparator | Participants randomized to the comparison arm will receive usual psychosocial care services routinely provided by our institution's pediatric complex care and palliative care interdisciplinary team. This psychosocial care includes routine clinical evaluations, emotional and social support, and care coordination services, which are delivered via scheduled outpatient clinic visits, phone/virtual consultations, or inpatient visits. Receives: Behavioral: Usual Psychosocial Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment Rate
Percentage of eligible caregivers approached who consent to participate, and percentage of consented participants who are successfully enrolled.
Measured: Approach-to-Consent: from initial approach to 12 weeks after initial approach. Consent-to-Enroll: 12 weeks from obtaining written informed consent .
Feasibility: Retention Rate
Percentage of randomized participants who complete the study protocol.
Measured: From study enrollment to 12-weeks post-enrollment
Feasibility: Data Collection Completion Rate
Percentage of required participant-reported outcome assessments successfully completed across all study time points.
Measured: From study enrollment to 12-weeks post-enrollment
Feasibility: Intervention Session Completion
Percentage of planned intervention sessions completed by end of trial.
Measured: From study enrollment to 12-weeks post-enrollment
Feasibility: Intervention Fidelity
Adherence of interventionists to protocol content, delivery, and procedures, evaluated using an intervention fidelity scoring matrix. For all intervention sessions, this matrix assesses the following domains: rapport building, professionalism, flexibility, engagement, protocol application, and pacing. Each domain is assessed on a 5-point Likert scale (Poor [1] to Excellent [5]). Additionally, each session will be assessed for delivery of session-specific content (e.g., "discussing concept of meaning"), also using a 5-point Likert scale. Session intervention fidelity will be calculated by averaging rating for each element; higher scores represent higher intervention fidelity.
Measured: From study enrollment to 12-weeks post-enrollment
Intervention and Trial Protocol Acceptability
Percentage of participants reporting high acceptability ("agree" or "completely agree") to participating in the intervention and trial protocol on post-study exit questionnaire.
Measured: From study enrollment to 12-weeks post-enrollment
Satisfaction with Intervention
Percentage of participants reporting high satisfaction ("satisfied" or "very satisfied") in the experiences with the MAPS intervention in post-study evaluation questionnaire.
Measured: From study enrollment to 12-weeks post-enrollment.
Secondary outcomes (11)
Change in Meaning-Focused Coping (PROMIS Item Bank v1.0 - Meaning and Purpose - Short Form 8a)
Assessed using the 8-item PROMIS Meaning and Purpose Short Form. Items evaluate self-reported sense of life direction, purpose, and value on a 5-point Likert scale (1 = "Not at all" to 5 = "Very much"). Item scores are summed and converted to a standardized T-score (mean = 50, SD = 10; typical range: 24.3 to 68.2). Higher T-scores indicate a higher sense of meaning and purpose.
Measured: Baseline and 12-weeks post-enrollment
PROMIS General Self-Efficacy
Assessed using the PROMIS General Self-Efficacy scale. Items evaluate a person's general confidence in their ability to carry out tasks and reach goals. Items are scored on a 5-point Likert scale and converted to a standardized T-score (mean = 50, standard deviation = 10; typical range approximately 20 to 80). Higher T-scores reflect greater general self-efficacy.
Measured: Baseline and 12-weeks post-enrollment
Change in Emotional Regulation Self-Efficacy (PROMIS Item Bank v1.0 - Self-Efficacy for Managing Emotions - Short Form 8a)
Assessed using the 8-item PROMIS Self-Efficacy for Managing Emotions Short Form. Items evaluate confidence in managing difficult emotional states on a 5-point Likert scale (1 = "I am not at all confident" to 5 = "I am very confident"). Item scores are summed and converted to a standardized T-score (mean = 50, SD = 10; typical range: 25.8 to 64.2). Higher T-scores represent greater self-efficacy for emotional regulation.
Measured: Baseline and 12-weeks post-enrollment
Change in Positive Affect (PROMIS Positive Affect Short Form)
Assessed using the PROMIS Positive Affect Short Form (15 items). Items evaluate feelings of happiness, joy, and positive emotional states over the past 7 days on a 5-point Likert scale. Scores are converted to a standardized T-score (mean = 50, standard deviation = 10; range approximately 20 to 80). Higher T-scores indicate higher levels of positive affect.
Measured: Baseline and 12-weeks post-enrollment
Change in Emotional Distress (PROMIS Anxiety, Depression, and Anger Short Forms)
Assessed using the PROMIS Anxiety Short Form (8 items), PROMIS Depression Short Form (8 items) and PROMIS Anger Short Form (5 items). Items evaluate self-reported symptoms over the past 7 days on a 5-point Likert scale. Each domain generates a separate standardized T-score (mean = 50, standard deviation = 10; range approximately 20 to 80). Higher T-scores indicate higher levels of anxiety, depression, and anger (greater emotional distress).
Measured: Baseline and 12-weeks post-enrollment
Change in Emotional Support (PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a)
Assessed using the 8-item PROMIS Emotional Support Short Form. Items evaluate perceived feelings of being cared for and having someone to listen to or confide in on a 5-point Likert scale (1 = "Never" to 5 = "Always"). Raw scores are converted to a standardized T-score (mean = 50, SD = 10; typical range: 25.3 to 63.8). Higher T-scores indicate higher levels of perceived emotional support.
Measured: Baseline and 12-weeks post-enrollment
Change in Global Health (PROMIS Scale v1.2 - Global Health)
Assessed using the 10-item PROMIS Global Health scale. Items evaluate overall perceptions of general health, physical health, mental health, quality of life, social activities, and pain/fatigue on 5-point Likert scales. Items are summarized into two primary domain subscales: Global Physical Health (GPH) and Global Mental Health (GMH). Raw subscale scores are converted to standardized T-scores (mean = 50, SD = 10; range: 16.2 to 67.7). Higher T-scores indicate better health functioning.
Measured: Baseline and 12-weeks post-enrollment
Change in Child Global Health (PROMIS Early Childhood Global Health)
Assessed using the parent-proxy PROMIS Early Childhood Global Health Module (8 items). Evaluates the child's overall physical, mental, and social health status on a 5-point scale. Raw scores are converted to a standardized T-score (mean = 50, SD = 10; range: approx. 16.2 to 66.8). Higher T-scores represent better overall child health status.
Measured: Baseline and 12-weeks post-enrollment
Change in Spiritual Well-Being (FACIT-Sp-12)
Assessed using the 12-item Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-Sp-12). Items evaluate spiritual well-being across two main domains (Meaning/Peace and Faith) or three subdomains (Meaning, Peace, and Faith) on a 5-point Likert scale (0 = "Not at all" to 4 = "Very much"). Total scores range from 0 to 48, with higher scores indicating greater spiritual well-being and a stronger sense of meaning, peace, and faith.
Measured: Baseline and 12-weeks post-enrollment
Change in Social Problem-Solving Ability (SPSI-R:SF)
Assessed using the 25-item Social Problem-Solving Inventory-Revised Short Form (SPSI-R:SF). Items evaluate real-world problem-solving attitudes and skills across 5 subscales: Positive Problem Orientation (PPO), Negative Problem Orientation (NPO), Rational Problem Solving (RPS), Impulsivity/Carelessness Style (ICS), and Avoidance Style (AS). Items are scored on a 5-point Likert scale (0 = "Not at all true of me" to 4 = "Extremely true of me"). Standardized total scores range from 0 to 20 (or converted standard scores with a mean of 100, SD = 15), with higher total scores reflecting more constructive and effective social problem-solving abilities.
Measured: Baseline and 12-weeks post-enrollment
Change in Child Symptom Experience (Memorial Symptom Assessment Scale)
Assessed using the Memorial Symptom Assessment Scale (MSAS) parent-proxy scale (20 items). Evaluates the frequency, severity, and distress associated with common physical and psychological symptoms. Symptom items are scored on multi-point Likert scales to yield subscale scores and a Total MSAS Score ranging from 0 to 100, where higher scores represent greater symptom frequency, severity, and distress.
Measured: Baseline to 12-weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family CaregiversStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 using a parallel-group design to receive either the MAPS (Meaning And Problem-Solving) behavioral intervention or usual psychosocial care over a 12-week period.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Justin Yu, University of Pittsburgh
- Investigators
- Justin A Yu, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876206
- Sponsor's protocol ID
- STUDY25030117
- Other IDs
- 5K23HD115947-02
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data, along with the study protocol and statistical analysis plan, will be available to qualified researchers upon reasonable request and creation of a data sharing agreement. Data will be made available following the publication of primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Pilot Randomized Controlled Trial of a Meaning-Centered Problem-Solving Therapy Intervention for Family Caregivers of Children With Medical Complexity
- ClinicalTrials.gov ID
- NCT07876206
- Acronym / sponsor ID
- STUDY25030117
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Oct 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.
This study aims to evaluate a new program specifically developed to better support parents and family caregivers of children with complex health needs. The name of this program is MAPS (Meaning and Problem Solving). The goal of MAPS is to improve caregivers' emotional well-being and confidence in dealing with adversity. The investigators are testing the program to see if parent and family caregiver participants find the MAPS program acceptable and to identify ways the investigators can improve it.
Detailed description
The goal of this pilot study is to evaluate whether conducting a randomized clinical trial of a novel psychological intervention, entitled MAPS, specifically designed for family caregivers of children with medical complexity, is feasible and acceptable. The investigators will compare participation in the MAPS program to usual psychosocial care. Family caregiver participants randomized to the MAPS intervention will participate in 8 one-on-one virtual sessions with a trained MAPS facilitator over 2-3 months, and complete a pre- and post-intervention survey questionnaire, as well as an exit interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 using a parallel-group design to receive either the MAPS (Meaning And Problem-Solving) behavioral intervention or usual psychosocial care over a 12-week period.
| Arm | Type | Receives |
|---|---|---|
| MAPS Intervention | Experimental | Behavioral: MAPS (Meaning And Problem Solving)Participants randomized to this experimental arm will undergo 8 one-on-one sessions with a trained MAPS interventionist over 2-3 months. Sessions can be conducted in-person or via videoconference (per participant preference); and will last 45- to 60-minutes in duration. |
| Usual Psychosocial Care | Active comparator | Behavioral: Usual Psychosocial CareParticipants randomized to the comparison arm will receive usual psychosocial care services routinely provided by our institution's pediatric complex care and palliative care interdisciplinary team. This psychosocial care includes routine clinical evaluations, emotional and social support, and care coordination services, which are delivered via scheduled outpatient clinic visits, phone/virtual consultations, or inpatient visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Family caregiver of a child or dependent adult with impaired capacity receiving medical care at UPMC Children's Hospital of Pittsburgh's Complex Care Center or from UPMC Children's Hospital of Pittsburgh's Supportive Care team.
- Caregiver has medical decision-making authority for their child (as determined by the clinical attending physician).
- Caregiver's child is medically complex, which is defined as 1+ chronic health conditions, major functional limitations, significant health service needs, and high health care utilization.
Key exclusion criteria (4 listed)
- Caregiver is <18 years of age.
- Caregiver does not have medical decision-making authority (e.g., grandparent accompanying child to appointment).
- Caregiver unable to complete intervention sessions in English.
- Caregivers of children who do not live at home (i.e., reside in long-term nursing care facilities).
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 |
|---|---|---|
| MAPS (Meaning And Problem Solving)The MAPS intervention is a manualized behavioral program, tailored for family caregivers of children with medical complexity, which consists of 8 one-on-one 45-60 minute sessions delivered by a trained interventionist. The intervention aims to improve participant mental health and emotional well-being by enhancing participants' sense of meaning and problem-solving skills. Key components adapted from meaning-centered psychotherapy include: identifying sources of meaning, guided imagery, personalized coping statements, meaningful activity scheduling, and values-based goal setting. Problem-solving skills-training is adapted from Bright IDEAS, a 5-step framework to teach problem-solving skills originally developed for mothers of children with cancer. Participants receive a workbook with reference materials, worksheets, and home practice exercises to promote skill mastery and routine maintenance. | Behavioural | MAPS Intervention |
| Usual Psychosocial CareParticipants randomized to the comparison arm will receive usual psychosocial care services routinely provided by our institution's pediatric complex care and palliative care interdisciplinary team. This psychosocial care includes routine clinical evaluations, emotional and social support, and care coordination services, which are delivered via scheduled outpatient clinic visits, phone/virtual consultations, or inpatient visits. | Behavioural | Usual Psychosocial Care |
Primary outcome
Feasibility: Recruitment Rate
Time frame: Approach-to-Consent: from initial approach to 12 weeks after initial approach. Consent-to-Enroll: 12 weeks from obtaining written informed consent .
Percentage of eligible caregivers approached who consent to participate, and percentage of consented participants who are successfully enrolled.
Feasibility: Retention Rate
Time frame: From study enrollment to 12-weeks post-enrollment
Percentage of randomized participants who complete the study protocol.
Feasibility: Data Collection Completion Rate
Time frame: From study enrollment to 12-weeks post-enrollment
Percentage of required participant-reported outcome assessments successfully completed across all study time points.
Feasibility: Intervention Session Completion
Time frame: From study enrollment to 12-weeks post-enrollment
Percentage of planned intervention sessions completed by end of trial.
Feasibility: Intervention Fidelity
Time frame: From study enrollment to 12-weeks post-enrollment
Adherence of interventionists to protocol content, delivery, and procedures, evaluated using an intervention fidelity scoring matrix. For all intervention sessions, this matrix assesses the following domains: rapport building, professionalism, flexibility, engagement, protocol application, and pacing. Each domain is assessed on a 5-point Likert scale (Poor [1] to Excellent [5]). Additionally, each session will be assessed for delivery of session-specific content (e.g., "discussing concept of meaning"), also using a 5-point Likert scale. Session intervention fidelity will be calculated by averaging rating for each element; higher scores represent higher intervention fidelity.
Intervention and Trial Protocol Acceptability
Time frame: From study enrollment to 12-weeks post-enrollment
Percentage of participants reporting high acceptability ("agree" or "completely agree") to participating in the intervention and trial protocol on post-study exit questionnaire.
Satisfaction with Intervention
Time frame: From study enrollment to 12-weeks post-enrollment.
Percentage of participants reporting high satisfaction ("satisfied" or "very satisfied") in the experiences with the MAPS intervention in post-study evaluation questionnaire.
11 secondary outcomes
Change in Meaning-Focused Coping (PROMIS Item Bank v1.0 - Meaning and Purpose - Short Form 8a)
Time frame: Baseline and 12-weeks post-enrollment
PROMIS General Self-Efficacy
Time frame: Baseline and 12-weeks post-enrollment
Change in Emotional Regulation Self-Efficacy (PROMIS Item Bank v1.0 - Self-Efficacy for Managing Emotions - Short Form 8a)
Time frame: Baseline and 12-weeks post-enrollment
Change in Positive Affect (PROMIS Positive Affect Short Form)
Time frame: Baseline and 12-weeks post-enrollment
Change in Emotional Distress (PROMIS Anxiety, Depression, and Anger Short Forms)
Time frame: Baseline and 12-weeks post-enrollment
Change in Emotional Support (PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a)
Time frame: Baseline and 12-weeks post-enrollment
Change in Global Health (PROMIS Scale v1.2 - Global Health)
Time frame: Baseline and 12-weeks post-enrollment
Change in Child Global Health (PROMIS Early Childhood Global Health)
Time frame: Baseline and 12-weeks post-enrollment
Change in Spiritual Well-Being (FACIT-Sp-12)
Time frame: Baseline and 12-weeks post-enrollment
Change in Social Problem-Solving Ability (SPSI-R:SF)
Time frame: Baseline and 12-weeks post-enrollment
Change in Child Symptom Experience (Memorial Symptom Assessment Scale)
Time frame: Baseline to 12-weeks post-enrollment
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 20 Oct 2026.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data, along with the study protocol and statistical analysis plan, will be available to qualified researchers upon reasonable request and creation of a data sharing agreement. Data will be made available following the publication of primary study results.
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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.
Justin A Yu, MD, MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAPS (Meaning And Problem Solving) and Usual Psychosocial Care in people with Family Caregivers and Children With Medical Complexity (CMC), run by University of Pittsburgh 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 3 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: opening soon, as of the sponsor's last update on 20 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment Rate (time frame: Approach-to-Consent: from initial approach to 12 weeks after initial approach. Consent-to-Enroll: 12 weeks from obtaining written informed consent .). 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?
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 20 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.