Child Behavior DisordersSC-PIESNCT05240222
Pre-Implementation Enhancement Strategy To Improve Teachers' Intention to Implement Evidence-Based Practices
A study testing Pre-implementation enhancement strategies (SC-PIES) in people with Child Behavior Disorders and Implementation Science, run by University of Iowa.
Trial summary
Background: As the most common setting where youth access behavioral health services, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the uptake and use of evidence-based practices (EBPs), which are often insufficient to produce desired… Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Disorders, Implementation Science, Adolescent Problem Behavior at School
- What is being tested?
- Pre-implementation enhancement strategies (SC-PIES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2016to 1 Jul 2017
- 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 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Teachers who have no prior training about Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
- Teachers who have no prior experience in implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
Who cannot join
- Teachers who have attended more than three training sessions about Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
- Teachers who have more than one month of experience in implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
About this study
Official title: A Theory-Informed Pre-Implementation Enhancement Strategy Targeting Mechanisms and Outcomes of Implementation: A Triple-Blind Randomized Controlled Trial
Background: As the most common setting where youth access behavioral health services, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the uptake and use of evidence-based practices (EBPs), which are often insufficient to produce desired implementation outcomes (e.g., intervention fidelity) and changes in youth behavioral health outcomes (e.g., reduced externalizing behaviors). There is a need for theoretically-informed pre-implementation enhancement strategies (PIES) that increase the yield of training and follow-up consultation. Specifically, social-cognitive theory explicates principles to inform the design of strategy content and specific mechanisms of behavior change, such as intentions to implement (ITI), to target via a PIES that increase provider to more active implementation strategies. Methods: This triple-blind randomized controlled trial preliminarily examined the efficacy of a pragmatic PIES (SC-PIES) to improve the implementation of universal EBPs in the education sector. Participants were randomly assigned to the treatment (PIES) or active control condition (meeting with administrators). The investigators assessed participants' ITI, intervention fidelity, and youth behavioral health outcome before, immediately after, and six-week following treatment.
Read the detailed description
- Background and study aims: As the most common setting where youth access behavioral health services, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the uptake and use of evidence-based practices (EBPs). However, these strategies alone are not sufficient to promote the desired implementation (e.g., intervention fidelity) and youth behavioral health outcomes (e.g., externalizing behaviors). Theory-informed pragmatic pre-implementation enhancement strategies (PIES) are needed to increase the yield of training and consultation. Specifically, social-cognitive theory explicates principles to inform the design of strategy content and specific mechanisms of behavior change (e.g., "intentions to implement"; ITI) to target to increase providers' responsiveness to training and consultation. This triple-blind parallel randomized controlled trial preliminarily examined the efficacy of a pragmatic PIES based on social-cognitive theories (SC-PIES) to improve the implementation and youth outcomes of universal EBPs in schools. Four aims will be examined:
- As compared to control, does the pre-implementation enhancement strategy based on social-cognitive theories (SC-PIES) significantly improve teachers' implementation intentions to implement PCBM practices at posttest after adjusting baseline and covariates?
- As compared to control, is receiving SC-PIES associated with significantly improved teachers' intervention fidelity and class-wide youth behavioral health outcome at the 6-week follow-up after adjusting for baseline and covariates?
- Does teachers' intention to implement mediate the association between study condition and intervention fidelity?
- Does teachers' intervention fidelity mediate the association between their intentions to implement and class-wide youth behavioral health outcomes?
- Who can participate? Any teacher who has no prior training about or experience of implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in a school district. No restriction on age, gender, experience, or other demographic variables.
- What does the study involve? The participating teachers will be randomly assigned to either the treatment (SC-PIES) or active control condition (administrative meeting). The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based PCBM practices and subsequent follow-up consultation. Teachers in the active control condition will meet with their administrators to talk about their work irrelevant to SC-PIES or student behaviors. The investigators assessed teachers' ITI, intervention fidelity, and youth behavioral outcome (academic engagement as an incompatible behavior to externalizing disorders) before treatment, immediately after training, and six weeks afterward.
- What are the possible benefits and risks of participating? Teachers participating in this study will benefit from expert training and consultation to improve their intentions and skills to implement a set of EBPs to help their students' behavioral problems. No risks to participants were expected based on relevant literature in education and implementation science.
- Conditions
- Child Behavior Disorders, Implementation Science, Adolescent Problem Behavior at School, Healthcare Providers
- Being tested
- Pre-implementation enhancement strategies (SC-PIES), Sham comparator
- Keywords
- Implementation Science, School Mental Health Services, Healthcare Providers, School Teachers
- Medical subject headings
- Child Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-implementation enhancement strategies (SC-PIES)Behavioural
The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based student behavioral management practices and follow-up consultation. SC-PIES content was grounded in three social-cognitive principles: (a) growth mindset, (b) saying-is-believing, and (c) commitment and consistency.
Sham comparatorOther
Participants in the active control condition will meet with school administrators to talk about their work irrelevant to SC-PIES or student behaviors. The meeting lasted for the same duration as the SC-PIES at the same time as those in the treatment condition.
| Study group | Role | What they receive |
|---|---|---|
| Theory-informed pre-implementation enhancement strategies (SC-PIES) | Experimental | The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based student behavioral management practices and subsequent follow-up consultation. The content of SC-PIES was grounded in three social-cognitive principles: (a) growth mindset, (b) saying-is-believing, and (c) commitment and consistency. Receives: Behavioral: Pre-implementation enhancement strategies (SC-PIES) |
| Active control | Sham comparator | Participants in the active control condition will meet with school administrators to talk about their work irrelevant to SC-PIES or student behaviors. The meeting lasted for the same duration as the SC-PIES at the same time as those in the treatment condition. Receives: Other: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Teachers' Intentions to Implement (ITI) at 3 Days
The Modified Intentions to Use Scale was adopted to assess the change in teachers' intentions to implement from baseline to immediate post-test. The scale is originally developed from research on practitioners' intention to adhere to measurement-based care and is consistent with the recommendations for assessing behavioral intentions based on the theory of planned behavior (Godin \& Kok, 1996). The scale consists of five items on a 7-point Likert scale ranging from "greatly disagree" to "greatly agree". The items were modified to specifically assess teachers' intentions to implement EBPs. The scale showed acceptable reliability and validity in prior research.
Measured: Three days following the baseline test of teachers' intentions to implement
Change from Baseline Teachers' Intervention Fidelity at 6 weeks.
A team of trained professionals, who were blinded to the random assignment results, conducted structured observations to assess the intervention fidelity, which is operationalized in this study as "adherence to core components of the classroom management practices". The data collection took place at pre-test and 6-week follow-up to allow enough time to detect and compare changes in intervention fidelity. First, during core instructional times, trained observers observed two occasions at pre-test and 6-week follow-up to code the presence or absence of the core components of the evidence-based practices. Immediately following the observations, these observers completed a fidelity rating rubric, which was created by operationalizing three core components of each PCBMs such that observers could reliably observe and rate them. The average of the observation coding and the rubric scores represents each teacher's fidelity.
Measured: Six weeks following the baseline test of teachers' intervention fidelity
Secondary outcomes (1)
Change from Baseline Students' Academic Engaged Time (AET) at 6 weeks
AET is defined as "any instance where youths are attending to instruction, watching the teacher or speaker, or concentrating on their classwork". This study will use Direct Behavior Ratings (DBRs) for academic engaged time (AET) with which a teacher observes a youth's AET throughout a predetermined interval. Based on the literature of DBRs, teacher-completed DBRs have strong correlations to Structured Direct Observation in assessing AET (Sanetti, 2009). The DBRs will be completed at pre-test and 6-week follow-up. For comparability across classrooms, each teacher completes DBRs during the reading/language arts block at the same time each day of the week for five randomly selected youths, whose results will be then averaged for that class. This approach has demonstrated adequate reliability and validity to capture class-wide AET in education literature (Sanetti, 2009).
Measured: Six weeks following the baseline test of students' AET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start22 Jul 2016
- Primary completion20 May 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child Behavior DisordersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a triple-blind parallel randomized controlled trial. Specifically, teachers from a diverse urban district were recruited and randomly assigned to either the treatment (SC-PIES) or active control condition (administrative meeting). Based on the condition assigned, teachers received the SC-PIES (or met with administrators) before EBP training. The investigators assessed teachers' ITI, intervention fidelity, and youth behavioral outcome (academic engagement as an incompatible behavior to externalizing disorders) before treatment, immediately after training, and six weeks afterward.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Minnesota
- Responsible party
- Principal investigator, Yanchen Zhang, University of Iowa
- Investigators
- Yanchen Zhang, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240222
- Sponsor's protocol ID
- PIES001
- Acronym
- SC-PIES
- Status last verified
- Feb 2022
- First submitted
- 10 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified datasets generated and analyzed during the current study are available in the Open Science Framework repository, \[osf.io/d5t4m/\].
Publications
Godin G, Kok G. The theory of planned behavior: a review of its applications to health-related behaviors. Am J Health Promot. 1996 Nov-Dec;11(2):87-98. doi: 10.4278/0890-1171-11.2.87.
PubMed 10163601Sanetti LM, Kratochwill TR. Toward developing a science of treatment integrity: Introduction to the special series. School Psychology Review. 2009 Dec 1;38(4):445.
Zhang Y, Cook CR, Azad GF, Larson M, Merle JL, Thayer J, Pauls A, Lyon AR. A Pre-Implementation Enhancement Strategy to Increase the Yield of Training and Consultation for School-Based Behavioral Preventive Practices: a Triple-Blind Randomized Controlled Trial. Prev Sci. 2023 Apr;24(3):552-566. doi: 10.1007/s11121-022-01464-3. Epub 2022 Nov 11.
PubMed 36367633
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory-Informed Pre-Implementation Enhancement Strategy Targeting Mechanisms and Outcomes of Implementation: A Triple-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05240222
- Acronym / sponsor ID
- SC-PIES / PIES001
- Conditions
- Child Behavior Disorders, Implementation Science, Adolescent Problem Behavior at School, Healthcare Providers
- Keywords
- Implementation Science, School Mental Health Services, Healthcare Providers, School Teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- University of Washington, University of Minnesota
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 15 Feb 2022 (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.
Background: As the most common setting where youth access behavioral health services, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the uptake and use of evidence-based practices (EBPs), which are often insufficient to produce desired implementation outcomes (e.g., intervention fidelity) and changes in youth behavioral health outcomes (e.g., reduced externalizing behaviors). There is a need for theoretically-informed pre-implementation enhancement strategies (PIES) that increase the yield of training and follow-up consultation. Specifically, social-cognitive theory explicates principles to inform the design of strategy content and specific mechanisms of behavior change, such as intentions to implement (ITI), to target via a PIES that increase provider to more active implementation strategies. Methods: This triple-blind randomized controlled trial preliminarily examined the efficacy of a pragmatic PIES (SC-PIES) to improve the implementation of universal EBPs in the education sector. Participants were randomly assigned to the treatment (PIES) or active control condition (meeting with administrators). The investigators assessed participants' ITI, intervention fidelity, and youth behavioral health outcome before, immediately after, and six-week following treatment.
Detailed description
- Background and study aims: As the most common setting where youth access behavioral health services, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the uptake and use of evidence-based practices (EBPs). However, these strategies alone are not sufficient to promote the desired implementation (e.g., intervention fidelity) and youth behavioral health outcomes (e.g., externalizing behaviors). Theory-informed pragmatic pre-implementation enhancement strategies (PIES) are needed to increase the yield of training and consultation. Specifically, social-cognitive theory explicates principles to inform the design of strategy content and specific mechanisms of behavior change (e.g., "intentions to implement"; ITI) to target to increase providers' responsiveness to training and consultation. This triple-blind parallel randomized controlled trial preliminarily examined the efficacy of a pragmatic PIES based on social-cognitive theories (SC-PIES) to improve the implementation and youth outcomes of universal EBPs in schools. Four aims will be examined:
- As compared to control, does the pre-implementation enhancement strategy based on social-cognitive theories (SC-PIES) significantly improve teachers' implementation intentions to implement PCBM practices at posttest after adjusting baseline and covariates?
- As compared to control, is receiving SC-PIES associated with significantly improved teachers' intervention fidelity and class-wide youth behavioral health outcome at the 6-week follow-up after adjusting for baseline and covariates?
- Does teachers' intention to implement mediate the association between study condition and intervention fidelity?
- Does teachers' intervention fidelity mediate the association between their intentions to implement and class-wide youth behavioral health outcomes?
- Who can participate? Any teacher who has no prior training about or experience of implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in a school district. No restriction on age, gender, experience, or other demographic variables.
- What does the study involve? The participating teachers will be randomly assigned to either the treatment (SC-PIES) or active control condition (administrative meeting). The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based PCBM practices and subsequent follow-up consultation. Teachers in the active control condition will meet with their administrators to talk about their work irrelevant to SC-PIES or student behaviors. The investigators assessed teachers' ITI, intervention fidelity, and youth behavioral outcome (academic engagement as an incompatible behavior to externalizing disorders) before treatment, immediately after training, and six weeks afterward.
- What are the possible benefits and risks of participating? Teachers participating in this study will benefit from expert training and consultation to improve their intentions and skills to implement a set of EBPs to help their students' behavioral problems. No risks to participants were expected based on relevant literature in education and implementation science.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a triple-blind parallel randomized controlled trial. Specifically, teachers from a diverse urban district were recruited and randomly assigned to either the treatment (SC-PIES) or active control condition (administrative meeting). Based on the condition assigned, teachers received the SC-PIES (or met with administrators) before EBP training. The investigators assessed teachers' ITI, intervention fidelity, and youth behavioral outcome (academic engagement as an incompatible behavior to externalizing disorders) before treatment, immediately after training, and six weeks afterward.
| Arm | Type | Receives |
|---|---|---|
| Theory-informed pre-implementation enhancement strategies (SC-PIES) | Experimental | Behavioral: Pre-implementation enhancement strategies (SC-PIES)The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based student behavioral management practices and subsequent follow-up consultation. The content of SC-PIES was grounded in three social-cognitive principles: (a) growth mindset, (b) saying-is-believing, and (c) commitment and consistency. |
| Active control | Sham comparator | Other: Sham comparatorParticipants in the active control condition will meet with school administrators to talk about their work irrelevant to SC-PIES or student behaviors. The meeting lasted for the same duration as the SC-PIES at the same time as those in the treatment condition. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Teachers who have no prior training about Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
- Teachers who have no prior experience in implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
Key exclusion criteria (2 listed)
- Teachers who have attended more than three training sessions about Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
- Teachers who have more than one month of experience in implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
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 |
|---|---|---|
| Pre-implementation enhancement strategies (SC-PIES)The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based student behavioral management practices and follow-up consultation. SC-PIES content was grounded in three social-cognitive principles: (a) growth mindset, (b) saying-is-believing, and (c) commitment and consistency. | Behavioural | Theory-informed pre-implementation enhancement strategies (SC-PIES) |
| Sham comparatorParticipants in the active control condition will meet with school administrators to talk about their work irrelevant to SC-PIES or student behaviors. The meeting lasted for the same duration as the SC-PIES at the same time as those in the treatment condition. | Other | Active control |
Primary outcome
Change from Baseline Teachers' Intentions to Implement (ITI) at 3 Days
Time frame: Three days following the baseline test of teachers' intentions to implement
The Modified Intentions to Use Scale was adopted to assess the change in teachers' intentions to implement from baseline to immediate post-test. The scale is originally developed from research on practitioners' intention to adhere to measurement-based care and is consistent with the recommendations for assessing behavioral intentions based on the theory of planned behavior (Godin \& Kok, 1996). The scale consists of five items on a 7-point Likert scale ranging from "greatly disagree" to "greatly agree". The items were modified to specifically assess teachers' intentions to implement EBPs. The scale showed acceptable reliability and validity in prior research.
Change from Baseline Teachers' Intervention Fidelity at 6 weeks.
Time frame: Six weeks following the baseline test of teachers' intervention fidelity
A team of trained professionals, who were blinded to the random assignment results, conducted structured observations to assess the intervention fidelity, which is operationalized in this study as "adherence to core components of the classroom management practices". The data collection took place at pre-test and 6-week follow-up to allow enough time to detect and compare changes in intervention fidelity. First, during core instructional times, trained observers observed two occasions at pre-test and 6-week follow-up to code the presence or absence of the core components of the evidence-based practices. Immediately following the observations, these observers completed a fidelity rating rubric, which was created by operationalizing three core components of each PCBMs such that observers could reliably observe and rate them. The average of the observation coding and the rubric scores represents each teacher's fidelity.
1 secondary outcome
Change from Baseline Students' Academic Engaged Time (AET) at 6 weeks
Time frame: Six weeks following the baseline test of students' AET
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 15 Feb 2022.
- Background: PubMed 10163601Godin G, Kok G. The theory of planned behavior: a review of its applications to health-related behaviors. Am J Health Promot. 1996 Nov-Dec;11(2):87-98. doi: 10.4278/0890-1171-11.2.87.
- BackgroundSanetti LM, Kratochwill TR. Toward developing a science of treatment integrity: Introduction to the special series. School Psychology Review. 2009 Dec 1;38(4):445.
- Derived from this study: PubMed 36367633Zhang Y, Cook CR, Azad GF, Larson M, Merle JL, Thayer J, Pauls A, Lyon AR. A Pre-Implementation Enhancement Strategy to Increase the Yield of Training and Consultation for School-Based Behavioral Preventive Practices: a Triple-Blind Randomized Controlled Trial. Prev Sci. 2023 Apr;24(3):552-566. doi: 10.1007/s11121-022-01464-3. Epub 2022 Nov 11.
- Individual participant dataSharing planned: Yes. The de-identified datasets generated and analyzed during the current study are available in the Open Science Framework repository, [osf.io/d5t4m/].
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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.
Yanchen Zhang, PhD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A study testing Pre-implementation enhancement strategies (SC-PIES) in people with Child Behavior Disorders and Implementation Science, run by University of Iowa.
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 2 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: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change from Baseline Teachers' Intentions to Implement (ITI) at 3 Days (time frame: Three days following the baseline test of teachers' intentions to implement). 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 NCT05240222, which also lists 3 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 15 Feb 2022.