DepressionNCT04030897
Promoting Treatment Access Following Pediatric Primary Care Depression Screening
A study testing Parent-Directed Online Single-Session Program, Youth-Directed Online Single-Session Program and Information/Psychoeducation/Referral in people with Depression, run by Stony Brook University at 1 site in United States.
Trial summary
Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Depression
- What is being tested?
- Parent-Directed Online Single-Session Program, Youth-Directed Online Single-Session Program and Information/Psychoeducation/Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 30 Aug 2021
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth is between the ages of 11 and 16, inclusive, at the time of study recruitment
- Youth reports a Pediatric Symptom Checklist 'Internalizing' score of 5 or higher (out of 10) at her/his most recent pediatric primary care visit at 1 of the 9 Stony Brook University-affiliated clinics participating in this study
- Parent and youth are comfortable with reading and writing in English
- Parent and youth are comfortable with online activity
Who cannot join
- Parent or youth is not comfortable reading and/or writing in English
- Parent or youth is not comfortable with online activity
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794-2500
Jessica L Schleider, PhD, 631-632-4131, jessica.schleider@stonybrook.edu
About this study
Official title: Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths
Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs; GM-SSIs have also improved parents' expectancies that psychotherapy could benefit their children's mental health. This project will test whether these online, youth- and parent-directed GM-SSIs-designed to reduce youth depressive symptoms and improve parents' mental health treatment expectancies, respectively-may increase mental health service access, reduce youth depressive symptoms, and relieve parental stress following PC-based youth MD screening. Youths reporting elevated MD symptoms at PC visits (N = 200) will receive either Information/Psychoeducation/Referral (IPR) or IPR plus parent- and youth-directed GM-SSIs (IPR+SSI). The investigators will examine whether IPR+SSI, versus IPR alone, increases MD service access; reduces parental stress; and reduces youth depressive symptoms across three months. Results may yield a disseminable model for promoting youth treatment access after PC-based depression screening.
- Conditions
- Depression
- Being tested
- Parent-Directed Online Single-Session Program, Youth-Directed Online Single-Session Program, Information/Psychoeducation/Referral
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Directed Online Single-Session ProgramBehavioural
Online, 15-minute self-administered program for parents
Youth-Directed Online Single-Session ProgramBehavioural
Also called Project Personality
Online, 30 minute self-administered program for youths
Information/Psychoeducation/ReferralBehavioural
Usual care at pediatric primary care clinics participating in this study
| Study group | Role | What they receive |
|---|---|---|
| Online Programs + Information/Psychoeducation/Referral (IPR) | Active comparator | Includes 2 online, one-session programs (one for youths; one for parents) and Primary Care-based IPR. The 30-min, self-administered YOUTH PROGRAM includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change. In the 15-min Qualtrics-based PARENT PROGRAM, parents read 2 scientific passages on (1) the notion that emotions are flexible in youth and adults, and (2) that failure promotes personal growth. After each passage, parents write a persuasive summary of its main arguments, directed to fellow parents who may benefit from the information. Receives: Behavioral: Parent-Directed Online Single-Session Program; Behavioral: Youth-Directed Online Single-Session Program; Behavioral: Information/Psychoeducation/Referral |
| Information/Psychoeducation/Referral (IPR; usual care control) | Placebo comparator | Information, Psychoeducation and Referral (IPR) represents usual care in the Stony Brook University Hospital's Pediatric Primary Care Division. Families of a youth with elevated MD symptoms during a PC visit receive a folder containing informational materials about the nature of depression and referrals to providers in their area. All families in this study will receive PC-based IPR. Receives: Behavioral: Information/Psychoeducation/Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Treatment-Seeking Behavior Checklist
At baseline and 3-month follow-up, parents will indicate whether they have engaged in each of four treatment-seeking behaviors for their child: researched local mental healthcare providers/agencies for their child; contacted a mental healthcare provider or agency about treatment for their child; contacted child's school regarding mental health supports for their child; and scheduled an appointment OR placed child on a waiting-list with a mental healthcare provider/agency. Total number of treatment-seeking behaviors between baseline and 3-month follow-up may range from 0 to 4. Individual behaviors are self-reported by parents on as 'yes' or 'no' (noting whether they engaged in the behavior during the study period). At baseline, parents will report on whether they engaged in these behaviors 'since the child's last doctor's appointment.' At follow-up, parents will report whether they have engaged in these behaviors 'since their past survey, 3 months ago.'
Measured: Baseline to 3-month follow-up
Change in Children's Depression Inventory 2 - Youth Report Total Score
Change in youth reported depressive symptoms, total score derived from 28-item CDI-2. Scores range from 0-56, with higher scores indicating higher levels of depression.
Measured: Baseline to 3-month follow-up.
Secondary outcomes (12)
Change in Pediatric Symptom Checklist - Youth-Report Total score
Youth-report measure of overall youth psychopathology. Youth rate 35 items on a 0-2 scale reflecting internalizing, externalizing, and attention-related symptoms. Scores range from 0 - 70. Higher scores indicate higher overall symptom severity.
Measured: Baseline to 3-month follow-up.
Change in Pediatric Symptom Checklist- Parent Report Total score
Youth-report measure of overall youth psychopathology. Youth rate 35 items on a 0-2 scale reflecting internalizing, externalizing, and attention-related symptoms. Scores range from 0 - 70. Higher scores indicate higher overall symptom severity.
Measured: Baseline to 3-month follow-up.
Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)
Parent-report measure of overall youth psychopathology. Parents rate 5 items on a 0-2 scale reflecting internalizing symptoms in their child. Scores range from 0-10. Higher scores indicate higher overall symptom severity.
Measured: Baseline to 3-month follow-up.
Change in Beck Hopelessness Scale - 4 (Youth Report)
Respondents (youths) report agreement with 4 items indicating levels of hopelessness about the future. Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12.
Measured: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Change in Beck Hopelessness Scale - 4 (Parent Report)
Respondents (parents) report agreement with 4 items indicating levels of hopelessness about the future. Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12.
Measured: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Change in Brief Symptom Inventory - 18
The Brief Symptom Inventory-18 (BSI-18) assesses self reported parent psychopathology and distress. Adult respondents rate endorsement of 18 physical and emotional complaints on a 0-4 Likert scale. The total sum score yields an additional total distress score (range: 0-72). Higher scores indicate higher levels of overall psychological distress.
Measured: Baseline to 3-month follow-up
Change in Barriers to Accessing Care Evaluation (BACE)
Parents rate the 30 items on a 0-3 scale indicating the degree to which various beliefs, concerns, circumstances, and logistical difficulties have stopped, delayed or discouraged them from getting professional care for their child's mental health problem. Higher total scores indicate greater perceived barriers to care. Scores range from 0-90, with higher scores indicating more overall barriers to accessing mental health care for their child.
Measured: Baseline to 3-month follow-up
Change in Attitudes Toward Therapy Scale - Parent
One-item measure used to assess parents' perceptions that therapy/counseling would be useful in reducing their child's emotional or behavioral difficulties, rated on a 0-10 scale (total score range: 0-10). Higher scores indicate stronger beliefs that therapy may help reduce mental health problems, whereas lower scores indicate weaker beliefs that therapy may help reduce mental health problems.
Measured: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Mental Health Treatment Access at 3-month follow-up
Parents will indicate (yes/no) whether their child has received (a) new and/or (b) continuing school-based, outpatient, or other mental health-related services since the child's recent PC appointment (at baseline) and since the baseline assessment (at 3-month follow-up).
Measured: 3-month follow-up
Change in Perceived Stress Scale
The PSS is a well-validated measure of the degree to which situations in one's life are appraised as stressful, unpredictable, and uncontrollable. Higher total scores indicate greater overall perceived stress. The scale includes 10 items rated on a 0-4 scales, and scores range from 0-40.
Measured: Baseline to 3-month follow-up
Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score
Youth-report measure of youth depressive symptoms. Youth rate 5 items reflecting internalizing symptoms on a scale from 0-2. Total scores range from 0 to 10. Higher scores indicate higher internalizing symptom severity.
Measured: Baseline to 3-month follow-up.
Change in Children's Depression Inventory 2 - Parent Report total score
Parent reported youth depressive symptoms, total score derived from 17-item parent-report version of CDI-2. Scores range from 0-54, and higher scores indicate greater youth depression severity.
Measured: Baseline to 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start15 Jan 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Youths reporting elevated MD symptoms at a PC visit (N = 200) will be randomly assigned to one of two conditions (within a waitlist-control design): Information, Psychoeducation, and Referral (IPR; ie., usual care, or the "control") or IPR enhanced with youth- and parent-directed online SSIs (IPR+SSI), designed to reduce youth MD symptoms and improve parents' expectancies of mental health treatment, respectively.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- The Klingenstein Third Generation Foundation
- Responsible party
- Principal investigator, Jessica Schleider, Stony Brook University
- Investigators
- Jessica Schleider, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030897
- Sponsor's protocol ID
- IRB2019-00241
- Status last verified
- Mar 2020
- First submitted
- 20 Jul 2019
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual-level participant data will be made publicly available on Open Science Framework upon completion of the grant period (August 2021).
Publications
Schleider JL, Dobias M, Fassler J, Shroff A, Pati S. Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Randomized Trial of Web-Based, Single-Session Interventions for Parents and Youths. J Am Acad Child Adolesc Psychiatry. 2020 Jun;59(6):770-773. doi: 10.1016/j.jaac.2020.01.025. Epub 2020 Apr 28. No abstract available.
PubMed 32666919
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths
- ClinicalTrials.gov ID
- NCT04030897
- Acronym / sponsor ID
- IRB2019-00241
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- The Klingenstein Third Generation Foundation
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 24 Jul 2019 (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.
Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs; GM-SSIs have also improved parents' expectancies that psychotherapy could benefit their children's mental health. This project will test whether these online, youth- and parent-directed GM-SSIs-designed to reduce youth depressive symptoms and improve parents' mental health treatment expectancies, respectively-may increase mental health service access, reduce youth depressive symptoms, and relieve parental stress following PC-based youth MD screening. Youths reporting elevated MD symptoms at PC visits (N = 200) will receive either Information/Psychoeducation/Referral (IPR) or IPR plus parent- and youth-directed GM-SSIs (IPR+SSI). The investigators will examine whether IPR+SSI, versus IPR alone, increases MD service access; reduces parental stress; and reduces youth depressive symptoms across three months. Results may yield a disseminable model for promoting youth treatment access after PC-based depression screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Youths reporting elevated MD symptoms at a PC visit (N = 200) will be randomly assigned to one of two conditions (within a waitlist-control design): Information, Psychoeducation, and Referral (IPR; ie., usual care, or the "control") or IPR enhanced with youth- and parent-directed online SSIs (IPR+SSI), designed to reduce youth MD symptoms and improve parents' expectancies of mental health treatment, respectively.
| Arm | Type | Receives |
|---|---|---|
| Online Programs + Information/Psychoeducation/Referral (IPR) | Active comparator | Behavioral: Parent-Directed Online Single-Session Program, Behavioral: Youth-Directed Online Single-Session Program, Behavioral: Information/Psychoeducation/ReferralIncludes 2 online, one-session programs (one for youths; one for parents) and Primary Care-based IPR. The 30-min, self-administered YOUTH PROGRAM includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change. In the 15-min Qualtrics-based PARENT PROGRAM, parents read 2 scientific passages on (1) the notion that emotions are flexible in youth and adults, and (2) that failure promotes personal growth. After each passage, parents write a persuasive summary of its main arguments, directed to fellow parents who may benefit from the information. |
| Information/Psychoeducation/Referral (IPR; usual care control) | Placebo comparator | Behavioral: Information/Psychoeducation/ReferralInformation, Psychoeducation and Referral (IPR) represents usual care in the Stony Brook University Hospital's Pediatric Primary Care Division. Families of a youth with elevated MD symptoms during a PC visit receive a folder containing informational materials about the nature of depression and referrals to providers in their area. All families in this study will receive PC-based IPR. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Youth is between the ages of 11 and 16, inclusive, at the time of study recruitment
- Youth reports a Pediatric Symptom Checklist 'Internalizing' score of 5 or higher (out of 10) at her/his most recent pediatric primary care visit at 1 of the 9 Stony Brook University-affiliated clinics participating in this study
- Parent and youth are comfortable with reading and writing in English
- Parent and youth are comfortable with online activity
Key exclusion criteria (2 listed)
- Parent or youth is not comfortable reading and/or writing in English
- Parent or youth is not comfortable with online activity
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 |
|---|---|---|
| Parent-Directed Online Single-Session ProgramOnline, 15-minute self-administered program for parents | Behavioural | Online Programs + Information/Psychoeducation/Referral (IPR) |
| Youth-Directed Online Single-Session ProgramAlso: Project PersonalityOnline, 30 minute self-administered program for youths | Behavioural | Online Programs + Information/Psychoeducation/Referral (IPR) |
| Information/Psychoeducation/ReferralUsual care at pediatric primary care clinics participating in this study | Behavioural | Information/Psychoeducation/Referral (IPR; usual care control), Online Programs + Information/Psychoeducation/Referral (IPR) |
Primary outcome
Mental Health Treatment-Seeking Behavior Checklist
Time frame: Baseline to 3-month follow-up
At baseline and 3-month follow-up, parents will indicate whether they have engaged in each of four treatment-seeking behaviors for their child: researched local mental healthcare providers/agencies for their child; contacted a mental healthcare provider or agency about treatment for their child; contacted child's school regarding mental health supports for their child; and scheduled an appointment OR placed child on a waiting-list with a mental healthcare provider/agency. Total number of treatment-seeking behaviors between baseline and 3-month follow-up may range from 0 to 4. Individual behaviors are self-reported by parents on as 'yes' or 'no' (noting whether they engaged in the behavior during the study period). At baseline, parents will report on whether they engaged in these behaviors 'since the child's last doctor's appointment.' At follow-up, parents will report whether they have engaged in these behaviors 'since their past survey, 3 months ago.'
Change in Children's Depression Inventory 2 - Youth Report Total Score
Time frame: Baseline to 3-month follow-up.
Change in youth reported depressive symptoms, total score derived from 28-item CDI-2. Scores range from 0-56, with higher scores indicating higher levels of depression.
12 secondary outcomes
Change in Pediatric Symptom Checklist - Youth-Report Total score
Time frame: Baseline to 3-month follow-up.
Change in Pediatric Symptom Checklist- Parent Report Total score
Time frame: Baseline to 3-month follow-up.
Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)
Time frame: Baseline to 3-month follow-up.
Change in Beck Hopelessness Scale - 4 (Youth Report)
Time frame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Change in Beck Hopelessness Scale - 4 (Parent Report)
Time frame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Change in Brief Symptom Inventory - 18
Time frame: Baseline to 3-month follow-up
Change in Barriers to Accessing Care Evaluation (BACE)
Time frame: Baseline to 3-month follow-up
Change in Attitudes Toward Therapy Scale - Parent
Time frame: Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).
Mental Health Treatment Access at 3-month follow-up
Time frame: 3-month follow-up
Change in Perceived Stress Scale
Time frame: Baseline to 3-month follow-up
Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score
Time frame: Baseline to 3-month follow-up.
Change in Children's Depression Inventory 2 - Parent Report total score
Time frame: Baseline to 3-month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 32666919Schleider JL, Dobias M, Fassler J, Shroff A, Pati S. Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Randomized Trial of Web-Based, Single-Session Interventions for Parents and Youths. J Am Acad Child Adolesc Psychiatry. 2020 Jun;59(6):770-773. doi: 10.1016/j.jaac.2020.01.025. Epub 2020 Apr 28. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual-level participant data will be made publicly available on Open Science Framework upon completion of the grant period (August 2021).
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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.
Jessica Schleider, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Directed Online Single-Session Program, Youth-Directed Online Single-Session Program and Information/Psychoeducation/Referral in people with Depression, run by Stony Brook University 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 2 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica L Schleider (631-632-4131, jessica.schleider@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Treatment-Seeking Behavior Checklist (time frame: Baseline to 3-month follow-up). The study lists 2 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 NCT04030897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.