StressNCT05032742
Parenting Stress mHealth
A study testing mHealth parenting stress app in people with Stress, run by University of California, San Francisco at 1 site in United States.
Trial summary
Parenting stress is a well-documented barrier to youth engagement in community-based substance use treatment. The current project aims to develop and evaluate a mobile health parenting stress intervention for caregivers of justice-involved youth, a population with high rates of substance use and low rates of treatment… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- mHealth parenting stress app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The following is a description for the inclusion criteria for aims 1 and 2 for caregivers participating in this research study.
- Eligible caregivers must be the parent or legal guardian of a youth who is:
- currently detained in a juvenile detention center or correctional facility, mandated by the juvenile justice system to a congregate out-of-home placement (e.g., group home);
- 12-17 years old;
- has an identified substance use or substance use and co-occurring mental health need;
- and is scheduled to be released into the community to the care of the enrolled caregiver.
Show all 14Show fewer
- The following is a description for the inclusion criteria for aim 3 for system stakeholders participating in this research study.
- Eligible behavioral health providers (e.g., substance use counselor) must:
- Provide substance use or dual diagnosis treatment justice-involved youth and their caregivers,
- be over 18 years old,
- and speak English fluently.
- Eligible juvenile probation officers must be:
- 18 years or older
- and speak fluent English.
Who cannot join
- lack of proficiency in English
- and cognitive impairment or active psychosis which precludes provision of informed consent.
- Caregivers who do not have access to a device with internet access will also not be eligible as this would preclude them from being able to participate in the mHealth intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94131
About this study
Official title: Reducing Parenting Stress to Facilitate Justice-Involved Youth's Treatment
Parenting stress is a well-documented barrier to youth engagement in community-based substance use treatment. The current project aims to develop and evaluate a mobile health parenting stress intervention for caregivers of justice-involved youth, a population with high rates of substance use and low rates of treatment engagement.
Read the detailed description
Justice-involved youth exhibit high rates of substance use and mental health symptoms, yet few receive treatment during detention or community re-entry. Once released into the community, caregivers must facilitate youth's treatment engagement, mobilizing significant resources and facing many barriers (e.g., transportation, mistrust) to do so. Parenting stress, which is heightened during youth detention and community reentry, is associated with greater perceived barriers to treatment, less youth therapeutic change throughout treatment, and premature treatment dropout. Addressing parenting stress improves youth treatment engagement and outcomes among youth exhibiting antisocial behavior, yet given the many barriers to treatment, novel approaches to intervention are needed; mobile health (mHealth) technology is one promising approach. Caregivers of justice-involved youth and system stakeholders are interested in mHealth treatment and mHealth addresses instrumental barriers (e.g., transportation) to treatment. Advances in technology and community engaged research allow for active stakeholder collaboration in mHealth application development, with no technological expertise required, through participatory informatics; caregiver involvement increases the likelihood the intervention will be relevant and efficacious. The purpose of this mixed-methods K23 study is to 1) develop a mHealth parenting stress intervention using participatory informatics; 2) assess the feasibility and acceptability of the participatory informatics approach and the intervention; 3) evaluate the intervention's preliminary efficacy in reducing parenting stress and increasing youth engagement in substance use or dual diagnosis treatment post-detention through a pilot randomized controlled trial; and 4) understand systems-level factors that could influence eventual system adoption and sustainability.
- Conditions
- Stress
- Being tested
- mHealth parenting stress app
- Keywords
- parenting stress, juvenile justice, digital health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth parenting stress appBehavioural
mHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement.
| Study group | Role | What they receive |
|---|---|---|
| mHealth parenting stress app | Experimental | mHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement. Receives: Behavioral: mHealth parenting stress app |
| Standard of care | No intervention | Caregiver participants will receive an informational brochure describing ways to support one's adolescent during detention and community reentry and any other usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal Mindfulness in Parenting Scale (Mindful Parenting)
The Interpersonal Mindfulness in Parenting Scale is an 8-item self-report of mindful parenting, including four sub-scales reflecting present-centered emotional awareness in parenting, present-centered attention in parenting, non-reactivity/low reactivity in parenting, and non-judgmental acceptance in parenting that will be used to measure mindful parenting as a construct. Each item is rated on a 1 to 5 scale and items are summed to create sub-scale scores (possible range=8 to 40); higher scores indicate greater mindful parenting.
Measured: 3 months post baseline
Interpersonal Mindfulness in Parenting Scale (Mindful Parenting)
The Interpersonal Mindfulness in Parenting Scale is an 8-item self-report of mindful parenting, including four sub-scales reflecting present-centered emotional awareness in parenting, present-centered attention in parenting, non-reactivity/low reactivity in parenting, and non-judgmental acceptance in parenting that will be used to measure mindful parenting as a construct. Each item is rated on a 1 to 5 scale and items are summed to create sub-scale scores (possible range=8 to 40); higher scores indicate greater mindful parenting.
Measured: 6 months post baseline
Stress Index for Parents of Adolescents (Parenting Stress)
The Stress Index for Parents of Adolescents (SIPA) is a 90-item self-report measure of parenting stress. Items are rated on a 1 to 5 scale and summed to create sub-scale scores; higher scores reflect greater parenting stress.
Measured: 3 months post baseline
Stress Index for Parents of Adolescents (Parenting Stress)
The Stress Index for Parents of Adolescents (SIPA) is a 90-item self-report measure of parenting stress. Items are rated on a 1 to 5 scale and summed to create sub-scale scores (possible range=90 to 450); higher scores reflect greater parenting stress.
Measured: 6 months post baseline
Parenting Self-Efficacy
Parenting Self-Efficacy Scale (PSES) is a 20-item assessment of caregivers' perceived parenting ability across 3 dimensions: parental connection, behavioral influence, and psychological autonomy and used to measure parenting self-efficacy. Items are rated on a scale from 0 to 10 (possible range=0 to 200) with higher scores reflecting greater parenting self-efficacy.
Measured: 3 months post baseline
Parenting Self-Efficacy
Parenting Self-Efficacy Scale (PSES) is a 20-item assessment of caregivers' perceived parenting ability across 3 dimensions: parental connection, behavioral influence, and psychological autonomy and used to measure parenting self-efficacy. Items are rated on a scale from 0 to 10 (possible range=0 to 200) with higher scores reflecting greater parenting self-efficacy.
Measured: 6 months post baseline
Child and Adolescent Services Assessment (Barriers to Youth Treatment)
The Child and Adolescent Services Assessment (CASA) is a parent-report instrument designed to assess the use of behavioral health services by children ages 8 years to 17 years. The CASA includes 31 settings covering inpatient, outpatient, and informal services provided by a variety of child-serving providers and sectors. This instrument collects information on whether a service was ever used, as well as more detailed information (length of stay/number of visits, focus of treatment) on services used in the recent past. Select items from the CASA will assess 16 barriers to youths' services use (e.g., language, transportation, cost, stigma). Caregivers will report whether each barrier was a concern during the 3 months prior to the youths' detention or for follow-ups, in the 3 months since the last assessment (6 months post baseline).
Measured: 3 months post baseline
Child and Adolescent Services Assessment (Barriers to Youth Treatment)
The Child and Adolescent Services Assessment (CASA) is a parent-report instrument designed to assess the use of behavioral health services by children ages 8 years to 17 years. The CASA includes 31 settings covering inpatient, outpatient, and informal services provided by a variety of child-serving providers and sectors. This instrument collects information on whether a service was ever used, as well as more detailed information (length of stay/number of visits, focus of treatment) on services used in the recent past. Select items from the CASA will assess 16 barriers to youths' services use (e.g., language, transportation, cost, stigma). Caregivers will report whether each barrier was a concern during the 3 months prior to the youths' detention or for follow-ups, in the 3 months since the last assessment (6 months post baseline).
Measured: 6 months post baseline
Motivation for Youth Treatment
Motivation for Youth's Treatment Scale (MYTS) is an 8-item measure of intrinsic motivation for youth treatment and assesses a youth and caregiver's problem recognition and treatment readiness. Responses are rated on a 1 to 5 scale and are summed to yield two sub-scale scores (problem recognition: possible range=3 to 15; treatment readiness: possible range=5 to 25). Higher scores reflect higher motivation.
Measured: 3 months post baseline
Motivation for Youth Treatment
Motivation for Youth's Treatment Scale (MYTS) is an 8-item measure of intrinsic motivation for youth treatment and assesses a youth and caregiver's problem recognition and treatment readiness. Responses are rated on a 1 to 5 scale and are summed to yield two sub-scale scores (problem recognition: possible range=3 to 15; treatment readiness: possible range=5 to 25). Higher scores reflect higher motivation.
Measured: 6 months post baseline
Secondary outcomes (2)
Youth Treatment Engagement
Caregiver report on whether youth initiated substance use, mental health, dual diagnosis, or family based treatment in the community (i.e., scheduled appointment, attended first appointment), treatment retention (i.e., number of sessions attended) is collected to measure youth treatment engagement. Caregiver report will also provide information on whether the youth complied with treatment mandated by the juvenile court (e.g., probation requirement).
Measured: 3 months post baseline
Youth Treatment Engagement
Caregiver report on whether youth initiated substance use, mental health, dual diagnosis, or family based treatment in the community (i.e., scheduled appointment, attended first appointment), treatment retention (i.e., number of sessions attended) is collected to measure youth treatment engagement. Caregiver report will also provide information on whether the youth complied with treatment mandated by the juvenile court (e.g., probation requirement).
Measured: 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start15 Sep 2021
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Johanna B Folk, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032742
- Sponsor's protocol ID
- K23DA050798
- Other IDs
- K23DA050798
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Folk JB, McBride E, Nova S, Hurtado Y, Tolou-Shams M. Co-Design of the RAISE Mobile Health Intervention for and with Caregivers of Detained Youth. Res Child Adolesc Psychopathol. 2025 Dec;53(12):1813-1827. doi: 10.1007/s10802-025-01361-7. Epub 2025 Sep 22.
PubMed 40976844Folk JB, Aguilera A, Chaplin TM, Tolou-Shams M. Stress Management Among Caregivers of Detained Youth: Protocol for Randomized Controlled Trial of the RAISE Web-Based mHealth App. JMIR Res Protoc. 2025 Jul 10;14:e67511. doi: 10.2196/67511.
PubMed 40638918
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Parenting Stress to Facilitate Justice-Involved Youth's Treatment
- ClinicalTrials.gov ID
- NCT05032742
- Acronym / sponsor ID
- K23DA050798
- Conditions
- Stress
- Keywords
- parenting stress, juvenile justice, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 2 Sep 2021 (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.
Parenting stress is a well-documented barrier to youth engagement in community-based substance use treatment. The current project aims to develop and evaluate a mobile health parenting stress intervention for caregivers of justice-involved youth, a population with high rates of substance use and low rates of treatment engagement.
Detailed description
Justice-involved youth exhibit high rates of substance use and mental health symptoms, yet few receive treatment during detention or community re-entry. Once released into the community, caregivers must facilitate youth's treatment engagement, mobilizing significant resources and facing many barriers (e.g., transportation, mistrust) to do so. Parenting stress, which is heightened during youth detention and community reentry, is associated with greater perceived barriers to treatment, less youth therapeutic change throughout treatment, and premature treatment dropout. Addressing parenting stress improves youth treatment engagement and outcomes among youth exhibiting antisocial behavior, yet given the many barriers to treatment, novel approaches to intervention are needed; mobile health (mHealth) technology is one promising approach. Caregivers of justice-involved youth and system stakeholders are interested in mHealth treatment and mHealth addresses instrumental barriers (e.g., transportation) to treatment. Advances in technology and community engaged research allow for active stakeholder collaboration in mHealth application development, with no technological expertise required, through participatory informatics; caregiver involvement increases the likelihood the intervention will be relevant and efficacious. The purpose of this mixed-methods K23 study is to 1) develop a mHealth parenting stress intervention using participatory informatics; 2) assess the feasibility and acceptability of the participatory informatics approach and the intervention; 3) evaluate the intervention's preliminary efficacy in reducing parenting stress and increasing youth engagement in substance use or dual diagnosis treatment post-detention through a pilot randomized controlled trial; and 4) understand systems-level factors that could influence eventual system adoption and sustainability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth parenting stress app | Experimental | Behavioral: mHealth parenting stress appmHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement. |
| Standard of care | No intervention | –Caregiver participants will receive an informational brochure describing ways to support one's adolescent during detention and community reentry and any other usual care. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- The following is a description for the inclusion criteria for aims 1 and 2 for caregivers participating in this research study.
- currently detained in a juvenile detention center or correctional facility, mandated by the juvenile justice system to a congregate out-of-home placement (e.g., group home);
- 12-17 years old;
- has an identified substance use or substance use and co-occurring mental health need;
- and is scheduled to be released into the community to the care of the enrolled caregiver.
Key exclusion criteria (3 listed)
- lack of proficiency in English
- and cognitive impairment or active psychosis which precludes provision of informed consent.
- Caregivers who do not have access to a device with internet access will also not be eligible as this would preclude them from being able to participate in the mHealth intervention.
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 |
|---|---|---|
| mHealth parenting stress appmHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement. | Behavioural | mHealth parenting stress app |
Primary outcome
Interpersonal Mindfulness in Parenting Scale (Mindful Parenting)
Time frame: 3 months post baseline
The Interpersonal Mindfulness in Parenting Scale is an 8-item self-report of mindful parenting, including four sub-scales reflecting present-centered emotional awareness in parenting, present-centered attention in parenting, non-reactivity/low reactivity in parenting, and non-judgmental acceptance in parenting that will be used to measure mindful parenting as a construct. Each item is rated on a 1 to 5 scale and items are summed to create sub-scale scores (possible range=8 to 40); higher scores indicate greater mindful parenting.
Interpersonal Mindfulness in Parenting Scale (Mindful Parenting)
Time frame: 6 months post baseline
The Interpersonal Mindfulness in Parenting Scale is an 8-item self-report of mindful parenting, including four sub-scales reflecting present-centered emotional awareness in parenting, present-centered attention in parenting, non-reactivity/low reactivity in parenting, and non-judgmental acceptance in parenting that will be used to measure mindful parenting as a construct. Each item is rated on a 1 to 5 scale and items are summed to create sub-scale scores (possible range=8 to 40); higher scores indicate greater mindful parenting.
Stress Index for Parents of Adolescents (Parenting Stress)
Time frame: 3 months post baseline
The Stress Index for Parents of Adolescents (SIPA) is a 90-item self-report measure of parenting stress. Items are rated on a 1 to 5 scale and summed to create sub-scale scores; higher scores reflect greater parenting stress.
Stress Index for Parents of Adolescents (Parenting Stress)
Time frame: 6 months post baseline
The Stress Index for Parents of Adolescents (SIPA) is a 90-item self-report measure of parenting stress. Items are rated on a 1 to 5 scale and summed to create sub-scale scores (possible range=90 to 450); higher scores reflect greater parenting stress.
Parenting Self-Efficacy
Time frame: 3 months post baseline
Parenting Self-Efficacy Scale (PSES) is a 20-item assessment of caregivers' perceived parenting ability across 3 dimensions: parental connection, behavioral influence, and psychological autonomy and used to measure parenting self-efficacy. Items are rated on a scale from 0 to 10 (possible range=0 to 200) with higher scores reflecting greater parenting self-efficacy.
Parenting Self-Efficacy
Time frame: 6 months post baseline
Parenting Self-Efficacy Scale (PSES) is a 20-item assessment of caregivers' perceived parenting ability across 3 dimensions: parental connection, behavioral influence, and psychological autonomy and used to measure parenting self-efficacy. Items are rated on a scale from 0 to 10 (possible range=0 to 200) with higher scores reflecting greater parenting self-efficacy.
Child and Adolescent Services Assessment (Barriers to Youth Treatment)
Time frame: 3 months post baseline
The Child and Adolescent Services Assessment (CASA) is a parent-report instrument designed to assess the use of behavioral health services by children ages 8 years to 17 years. The CASA includes 31 settings covering inpatient, outpatient, and informal services provided by a variety of child-serving providers and sectors. This instrument collects information on whether a service was ever used, as well as more detailed information (length of stay/number of visits, focus of treatment) on services used in the recent past. Select items from the CASA will assess 16 barriers to youths' services use (e.g., language, transportation, cost, stigma). Caregivers will report whether each barrier was a concern during the 3 months prior to the youths' detention or for follow-ups, in the 3 months since the last assessment (6 months post baseline).
Child and Adolescent Services Assessment (Barriers to Youth Treatment)
Time frame: 6 months post baseline
The Child and Adolescent Services Assessment (CASA) is a parent-report instrument designed to assess the use of behavioral health services by children ages 8 years to 17 years. The CASA includes 31 settings covering inpatient, outpatient, and informal services provided by a variety of child-serving providers and sectors. This instrument collects information on whether a service was ever used, as well as more detailed information (length of stay/number of visits, focus of treatment) on services used in the recent past. Select items from the CASA will assess 16 barriers to youths' services use (e.g., language, transportation, cost, stigma). Caregivers will report whether each barrier was a concern during the 3 months prior to the youths' detention or for follow-ups, in the 3 months since the last assessment (6 months post baseline).
Motivation for Youth Treatment
Time frame: 3 months post baseline
Motivation for Youth's Treatment Scale (MYTS) is an 8-item measure of intrinsic motivation for youth treatment and assesses a youth and caregiver's problem recognition and treatment readiness. Responses are rated on a 1 to 5 scale and are summed to yield two sub-scale scores (problem recognition: possible range=3 to 15; treatment readiness: possible range=5 to 25). Higher scores reflect higher motivation.
Motivation for Youth Treatment
Time frame: 6 months post baseline
Motivation for Youth's Treatment Scale (MYTS) is an 8-item measure of intrinsic motivation for youth treatment and assesses a youth and caregiver's problem recognition and treatment readiness. Responses are rated on a 1 to 5 scale and are summed to yield two sub-scale scores (problem recognition: possible range=3 to 15; treatment readiness: possible range=5 to 25). Higher scores reflect higher motivation.
2 secondary outcomes
Youth Treatment Engagement
Time frame: 3 months post baseline
Youth Treatment Engagement
Time frame: 6 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 40976844Folk JB, McBride E, Nova S, Hurtado Y, Tolou-Shams M. Co-Design of the RAISE Mobile Health Intervention for and with Caregivers of Detained Youth. Res Child Adolesc Psychopathol. 2025 Dec;53(12):1813-1827. doi: 10.1007/s10802-025-01361-7. Epub 2025 Sep 22.
- Derived from this study: PubMed 40638918Folk JB, Aguilera A, Chaplin TM, Tolou-Shams M. Stress Management Among Caregivers of Detained Youth: Protocol for Randomized Controlled Trial of the RAISE Web-Based mHealth App. JMIR Res Protoc. 2025 Jul 10;14:e67511. doi: 10.2196/67511.
- 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. This study is not recruiting at the moment.
Johanna B Folk, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth parenting stress app in people with Stress, run by University of California, San Francisco 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 14 inclusion and 3 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: finished, as of the sponsor's last update on 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interpersonal Mindfulness in Parenting Scale (Mindful Parenting) (time frame: 3 months post baseline). The study lists 10 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 NCT05032742, which also lists 2 linked publications.
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 13 Oct 2026.