ParentingMSSOSNCT05117099
Middle School Success Over Stress
A study testing Family Check-Up in people with Parenting and Parent-Child Relations, run by University of Oregon at 1 site in United States.
Trial summary
It is clear that the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, social/familial functioning, as well as responses to mandated safety measures (e.g. social distancing, stay-at-home orders, mask-wearing). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parenting, Parent-Child Relations, Depression
- What is being tested?
- Family Check-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 23 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A caregiver must have a child between the ages of 10 and 14;
- the caregiver must be the parent or legal guardian of the participating youth;
- the caregiver must have a smartphone with text messaging capability and access to email; and
- the caregiver must score at least 1 or above on the Patient Health Questionnaire-2, or score at least 2 on any item of the Perceived Stress Scale-4.
Who cannot join
- the caregiver is unable to read in either English or Spanish;
- the child is unable to complete the survey without parent's help; or
- the family is already participating in another study of the University of Oregon's Prevention Science Institute.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oregon Prevention Science Institute
Portland, Oregon, 97209
About this study
Official title: Supplement: Long-term Effects of the Family Check-up on Depression and Suicide Across Trials and Development
It is clear that the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, social/familial functioning, as well as responses to mandated safety measures (e.g. social distancing, stay-at-home orders, mask-wearing). Furthermore, families of school-age children have had to navigate online instruction and home schooling in the context of these difficult circumstances with little preparation for doing so effectively. School districts have varied widely in their ability to support parents during this crisis. These stressors are likely to have disproportionately adverse effects on lower-income and racial/ ethnic minority populations, for whom economic, academic, and family-level challenges were already pronounced. For instance, health effects of COVID-19 have hit African American and Latinx populations with disproportionate severity, including higher rates of hospitalization and death. Given the scale of pandemic impacts for families with school-aged children, the identification of effective family-focused interventions that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represent critical public health goals.
In this research study the investigators will adapt and test the efficacy of the Family Check-Up Online as a treatment to foster resilient family functioning in response to the COVID-19 pandemic. The investigators will test the effects of the adapted FCU Online program on key mechanisms of change that are predicted to directly impact child and family functioning: parenting skills, parental depression, and parent and child self-regulation. The investigators predict that changes in these key targets of the intervention will impact participant's response to the COVID-19 pandemic, including youth depression and behavior problems, the ability to cope with pandemic-focused stressors, and social/familial functioning.
- Conditions
- Parenting, Parent-Child Relations, Depression, Self-regulation
- Being tested
- Family Check-Up
- Medical subject headings
- Depression, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check-UpBehavioural
This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be offered.
| Study group | Role | What they receive |
|---|---|---|
| FCU Online + Coach | Experimental | Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include videos, animated videos, parenting tips, and interactives to help practice parenting skills.Telehealth coaching sessions will focus on Healthy Behaviors, Positive Parenting, Rules and Consequences, School Support, and Communication. Receives: Behavioral: Family Check-Up |
| Waitlist Control | No intervention | Parents in this arm will initially serve as the control group but will receive access to the FCU Online website and telehealth coaching after completing three waves of data collection (baseline, 2-mo, and 4-mo follow-up). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Parent Mental Health and Well-being (Parent Report)
Parents reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.
Measured: baseline, 2 months, 4 months, 6 months
Change From Baseline in Parental Stress (Parent Report)
Parents reported on their parenting stress using the Parenting Stress Index (PSI), a 14-item questionnaire. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never, almost never, sometimes, fairly often, very often). Scores ranged from 0-4. High scores indicate greater parenting stress.
Measured: baseline, 2 months, 4 months, 6 months
Change From Baseline in Child Behavior and Emotional Problems (Parent Report)
Parents reported on their child's problem behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item brief behavioral screening questionnaire that consists of 5 subscales with 5 questions each. The 5 subscales are conduct problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 3-pt scale (not true, somewhat true, and certainly true). Response options for each item ranged from 0-2. Subscale totals were created by summing responses for a possible range of 0-10 for each subscale. The sums from each subscale were summed to create a composite score. High scores indicate greater conduct problems.
Measured: baseline, 2 months, 4 months, 6 months
Change From Baseline in Youth Depression (Parent Report)
Parents reported on their child's depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their child's mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.
Measured: baseline, 2 months, 4 months, 6 months
Change From Baseline in Parenting Skills (Parent Report)
Parents reported on their parenting skills using a version of the Parenting Young Children Questionnaire (PARYC). The PARYC version adapted for this study was a 21-item questionnaire. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 5-pt scale (never, rarely, sometimes, often, and very often). Scores for each item ranged from 0-4, and scores were averaged to create a total score. High scores indicate greater parenting skills.
Measured: baseline, 2 months, 4 months, 6 months
Change From Baseline in Positive Family Relationships (Parent Report)
Parents reported on their family relationships using a "family togetherness" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.
Measured: baseline, 2 months, 4 months, 6 months
Change From Baseline in Family Conflict (Parent Report)
Parents reported on their family conflict using a "family conflict" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores for each item ranged from 0-6, and scores were averaged to create a total score. High scores indicate increased family conflict.
Measured: baseline, 2 months, 4 months, 6 months
Change From Baseline in Youth Depression (Child Report)
Youth reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire modified for teen use. Youth were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores for each item ranged from 1-4, and scores were averaged to create a total score. High scores indicate greater depressive symptoms.
Measured: baseline, 6 months
Change From Baseline in Positive Family Relationships (Child Report)
Youth reported on their family relationships using a "family togetherness" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.
Measured: baseline, 6 months
Change From Baseline in Family Conflict (Child Report)
Youth reported on their family conflict using a "family conflict" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores ranged from 1-7. High scores indicate increased family conflict.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start11 Oct 2021
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Families will be assigned to treatment vs. waitlist control. The investigators will assess families at baseline and at 2-, 4-, and 6-month follow-ups. Families in the treatment condition will receive the intervention between baseline and the 2-month follow-up.The control group will receive the intervention following the 4-month assessment.
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stormshak, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117099
- Sponsor's protocol ID
- 3R01MH122213-01S1
- Acronym
- MSSOS
- Status last verified
- Jan 2024
- First submitted
- 1 Nov 2021
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stormshak E, Connell A, Mauricio AM, McLaughlin M, Caruthers A. Digital Health Delivery of Parenting Skills to Improve Conduct Problems in Middle School Youth Across Two Distinct Randomized Trials. Prev Sci. 2025 May;26(4):582-591. doi: 10.1007/s11121-024-01750-2. Epub 2024 Nov 18.
PubMed 39556238Mauricio AM, Hails KA, Caruthers AS, Connell AM, Stormshak EA. Family Check-Up Online: Effects of a Virtual Randomized Trial on Parent Stress, Parenting, and Child Outcomes in Early Adolescence. Prev Sci. 2026 Jan;27(1):119-130. doi: 10.1007/s11121-024-01725-3. Epub 2024 Sep 24.
PubMed 39316242
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplement: Long-term Effects of the Family Check-up on Depression and Suicide Across Trials and Development
- ClinicalTrials.gov ID
- NCT05117099
- Acronym / sponsor ID
- MSSOS / 3R01MH122213-01S1
- Conditions
- Parenting, Parent-Child Relations, Depression, Self-regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is clear that the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, social/familial functioning, as well as responses to mandated safety measures (e.g. social distancing, stay-at-home orders, mask-wearing). Furthermore, families of school-age children have had to navigate online instruction and home schooling in the context of these difficult circumstances with little preparation for doing so effectively. School districts have varied widely in their ability to support parents during this crisis. These stressors are likely to have disproportionately adverse effects on lower-income and racial/ ethnic minority populations, for whom economic, academic, and family-level challenges were already pronounced. For instance, health effects of COVID-19 have hit African American and Latinx populations with disproportionate severity, including higher rates of hospitalization and death. Given the scale of pandemic impacts for families with school-aged children, the identification of effective family-focused interventions that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represent critical public health goals.
In this research study the investigators will adapt and test the efficacy of the Family Check-Up Online as a treatment to foster resilient family functioning in response to the COVID-19 pandemic. The investigators will test the effects of the adapted FCU Online program on key mechanisms of change that are predicted to directly impact child and family functioning: parenting skills, parental depression, and parent and child self-regulation. The investigators predict that changes in these key targets of the intervention will impact participant's response to the COVID-19 pandemic, including youth depression and behavior problems, the ability to cope with pandemic-focused stressors, and social/familial functioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Families will be assigned to treatment vs. waitlist control. The investigators will assess families at baseline and at 2-, 4-, and 6-month follow-ups. Families in the treatment condition will receive the intervention between baseline and the 2-month follow-up.The control group will receive the intervention following the 4-month assessment.
| Arm | Type | Receives |
|---|---|---|
| FCU Online + Coach | Experimental | Behavioral: Family Check-UpParents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include videos, animated videos, parenting tips, and interactives to help practice parenting skills.Telehealth coaching sessions will focus on Healthy Behaviors, Positive Parenting, Rules and Consequences, School Support, and Communication. |
| Waitlist Control | No intervention | –Parents in this arm will initially serve as the control group but will receive access to the FCU Online website and telehealth coaching after completing three waves of data collection (baseline, 2-mo, and 4-mo follow-up). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A caregiver must have a child between the ages of 10 and 14;
- the caregiver must be the parent or legal guardian of the participating youth;
- the caregiver must have a smartphone with text messaging capability and access to email; and
- the caregiver must score at least 1 or above on the Patient Health Questionnaire-2, or score at least 2 on any item of the Perceived Stress Scale-4.
Key exclusion criteria (3 listed)
- the caregiver is unable to read in either English or Spanish;
- the child is unable to complete the survey without parent's help; or
- the family is already participating in another study of the University of Oregon's Prevention Science Institute.
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 |
|---|---|---|
| Family Check-UpThis intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be offered. | Behavioural | FCU Online + Coach |
Primary outcome
Change From Baseline in Parent Mental Health and Well-being (Parent Report)
Time frame: baseline, 2 months, 4 months, 6 months
Parents reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.
Change From Baseline in Parental Stress (Parent Report)
Time frame: baseline, 2 months, 4 months, 6 months
Parents reported on their parenting stress using the Parenting Stress Index (PSI), a 14-item questionnaire. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never, almost never, sometimes, fairly often, very often). Scores ranged from 0-4. High scores indicate greater parenting stress.
Change From Baseline in Child Behavior and Emotional Problems (Parent Report)
Time frame: baseline, 2 months, 4 months, 6 months
Parents reported on their child's problem behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item brief behavioral screening questionnaire that consists of 5 subscales with 5 questions each. The 5 subscales are conduct problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 3-pt scale (not true, somewhat true, and certainly true). Response options for each item ranged from 0-2. Subscale totals were created by summing responses for a possible range of 0-10 for each subscale. The sums from each subscale were summed to create a composite score. High scores indicate greater conduct problems.
Change From Baseline in Youth Depression (Parent Report)
Time frame: baseline, 2 months, 4 months, 6 months
Parents reported on their child's depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their child's mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.
Change From Baseline in Parenting Skills (Parent Report)
Time frame: baseline, 2 months, 4 months, 6 months
Parents reported on their parenting skills using a version of the Parenting Young Children Questionnaire (PARYC). The PARYC version adapted for this study was a 21-item questionnaire. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 5-pt scale (never, rarely, sometimes, often, and very often). Scores for each item ranged from 0-4, and scores were averaged to create a total score. High scores indicate greater parenting skills.
Change From Baseline in Positive Family Relationships (Parent Report)
Time frame: baseline, 2 months, 4 months, 6 months
Parents reported on their family relationships using a "family togetherness" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.
Change From Baseline in Family Conflict (Parent Report)
Time frame: baseline, 2 months, 4 months, 6 months
Parents reported on their family conflict using a "family conflict" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores for each item ranged from 0-6, and scores were averaged to create a total score. High scores indicate increased family conflict.
Change From Baseline in Youth Depression (Child Report)
Time frame: baseline, 6 months
Youth reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire modified for teen use. Youth were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores for each item ranged from 1-4, and scores were averaged to create a total score. High scores indicate greater depressive symptoms.
Change From Baseline in Positive Family Relationships (Child Report)
Time frame: baseline, 6 months
Youth reported on their family relationships using a "family togetherness" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.
Change From Baseline in Family Conflict (Child Report)
Time frame: baseline, 6 months
Youth reported on their family conflict using a "family conflict" scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores ranged from 1-7. High scores indicate increased family conflict.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39556238Stormshak E, Connell A, Mauricio AM, McLaughlin M, Caruthers A. Digital Health Delivery of Parenting Skills to Improve Conduct Problems in Middle School Youth Across Two Distinct Randomized Trials. Prev Sci. 2025 May;26(4):582-591. doi: 10.1007/s11121-024-01750-2. Epub 2024 Nov 18.
- Derived from this study: PubMed 39316242Mauricio AM, Hails KA, Caruthers AS, Connell AM, Stormshak EA. Family Check-Up Online: Effects of a Virtual Randomized Trial on Parent Stress, Parenting, and Child Outcomes in Early Adolescence. Prev Sci. 2026 Jan;27(1):119-130. doi: 10.1007/s11121-024-01725-3. Epub 2024 Sep 24.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth Stormshak, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check-Up in people with Parenting and Parent-Child Relations, run by University of Oregon 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 4 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 18 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Parent Mental Health and Well-being (Parent Report) (time frame: baseline, 2 months, 4 months, 6 months). 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 NCT05117099, 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 18 Apr 2024.