Parent-Child RelationsLTP-BNCT05356247
Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting
A study testing Lausanne Trialogue Play Brief in people with Parent-Child Relations and Family Relations, run by York University at 1 site in Canada.
Trial summary
The current study is a feasibility pilot of the Lausanne Trialogue Play paradigm Intervention - Brief (LTP-Brief), a family systems therapy implemented in a community mental health setting. We will study the ultrabrief, virtual therapy to assess the feasibility of a future pilot RCT. Read more about this study
- Who is it for?
- Ages 0 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Family Relations, Internet-Based Intervention
- What is being tested?
- Lausanne Trialogue Play Brief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 1 Sep 2023
- 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 0 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The sample will comprise of families referred to the outpatient mental health services at Sick Kids Center for Community Mental Health (SKCCMH), a non-profit children's mental health treatment centre in Toronto, ON, Canada.
- Participants will include children ages 0 months to 15.11 years old, and their caregivers, though the majority will fall in the range of 3- to 14-years-old.
- The first 25 families to be referred to the LTP-B service and who agree to participate in research will be included.
Who cannot join
- No exclusion criteria beyond what is standard for the clinical service at SKCCMH.
Trial locations and contacts
1 site in 1 country.
Diane Philipps, PhD contact
Canada1 site, 1 recruiting
- Recruiting
York University
Toronto, Ontario, M3J 1P3
Heather Prime, PhD, hprime@yorku.ca
Heather Prime, PhD
About this study
Official title: Lausanne Trialogue Paradigm - Brief: A Family Systems Model to Address Child Mental Health in a Community Mental Health Setting
The current study is a feasibility pilot of the Lausanne Trialogue Play paradigm Intervention - Brief (LTP-Brief), a family systems therapy implemented in a community mental health setting. We will study the ultrabrief, virtual therapy to assess the feasibility of a future pilot RCT. Feasibility metrics include resource, scientific, and management considerations, as well as an examination of pre-post change in future child and family outcomes of interest.
Read the detailed description
COVID-19 represents an acute crisis to children's mental health, with potential for long-term consequences. There is evidence for elevated mental health symptomatology in children since the start of the pandemic, with the emergence of stress-related disorders and the exacerbation of pre-existing disorders. Indeed, the pandemic has had detrimental effects on family life due to widespread job loss and financial insecurity, and increases to parental psychological distress, mental illness, and substance use. Social consequences of COVID-19 are expected to have cascading negative effects on child mental health symptoms. Thus, a COVID-19 family recovery program is critically needed, both during and after the pandemic, to manage the current mental health crisis in children and create cascading and sustainable effects for lifelong physical and mental health. The main goal of the the current study is to investigate feasibility of a future pilot and/or main RCT of a brief, virtual mental health treatment program for children and families designed to optimize reach of services. Specifically, the Lausanne Trialogue Play paradigm assessment is a semi-structured assessment of whole family interactions, with emphasis on the co-parenting relationship, which has been used extensively in research settings for assessment and consultative purposes. The current study will assess the feasibility of using the LTP in an assessment-as-treatment model. This brief treatment program, called the LTP-Brief intervention (LTP-B) will consist of a family play assessment (including an LTP assessment) with video feedback to caregivers as a method for promoting change in family interaction patterns. By targeting change across the family system, rather than focusing on specific child mental health symptoms directly, the model addresses upheaval of family life during COVID-19 and has potential to create sustainable improvements in family well-being within a short period of time.
- Conditions
- Parent-Child Relations, Family Relations, Internet-Based Intervention, Mental Health Issue, Behavioral Problem
- Being tested
- Lausanne Trialogue Play Brief
- Keywords
- Child Mental Health, Family Systems, Coparenting, Single arm pre-post design, COVID-19 Family Recovery
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lausanne Trialogue Play BriefBehavioural
Also called LTP-B
The brief treatment program will consist of an LTP family assessment with video feedback to caregivers to address family interaction patterns and child mental health. Families will participate in four sessions conducted online using the Zoom for Healthcare platform. In the first session, families will engage in a family assessment in different groupings that will be recoded on zoom and used later in the treatment. In the second session, taking place one week later, families will take part in a mini assessment to learn more about the difficulties of the child. In the third session, the clinical team will share videos of the family assessment to the parents and discuss the families strengths, concerns, and goals for moving forward. In the fourth session, taking place one month after the third session, families will participate in a check-in session, debriefing the family assessment.
| Study group | Role | What they receive |
|---|---|---|
| LTP-B Intervention | Experimental | Families will take part in an online semi-structured assessment and video feedback paradigm of family interactions, with an emphasis on co-parenting and parent-child relations. Receives: Behavioral: Lausanne Trialogue Play Brief |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19-related Family Stressors
Descriptive (no criterion for success): Family Stressor Scale. Minimum score=16, maximum score=48. Higher scores correspond to worse outcomes.
Measured: Time 0, 3
COVID-19-related Family Positive Adaptation
Descriptive (no criterion for success): COVID-19 Family Positive Adaptation Scale. Minimum score=14, maximum score=42. Higher scores correspond to better outcomes.
Measured: Time 0, 3
Therapeutic Alliance
Descriptive (no criterion for success): Working Alliance Inventory-Short Revised (WAI-SR). Minimum score=12, maximum score=60. Higher scores correspond to better outcomes.
Measured: Time 1, 2, 3, 5
Form Research-Clinical Partnership (1) - Clinical-Research Meetings
Criterion for success: Meet once monthly throughout the course of the study.
Measured: Time -1 to end of study
Form Research-Clinical Partnership (2) - Protocol Development - a
Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).
Measured: Time -1
Form Research-Clinical Partnership (3) - Protocol Development - b
Criterion for success: Submission of protocol for registration to clinicaltrials.gov and/or journal publications.
Measured: Time -1
Research-Clinical Communication (1) - Clients Referred to LTP-B
Criterion for success: 95% of clients referred to LTP-B to be asked permission to be contacted by the research team.
Measured: Time -1
Research-Clinical Communication (2) - Clients Transferred to Research Team
Criterion for success: 95% of clients that agree to research are transferred to the research team for contact.
Measured: Time -1
Research-Clinical Communication (3) - Clinical Visits Shared
Criterion for success: 95% of participants' scheduled clinical visits to be shared with the research team.
Measured: Time -1 to end of study
Research-Clinical Communication (4) - Videos Shared
Criterion for success: 95% of participant videos (previously consented) to be successfully shared with the research team.
Measured: Time 1, 2, 3
Clinical Service Flow (1) - Clients Referred
Criterion for success: 3 families to be referred to the LTP-B per month.
Measured: Time -1
Clinical Service Flow (2) - Service Provision
Criterion for success: 2 families to be seen by the LTP-B team per month.
Measured: Time -1
Participant Recruitment (1) - Agree to Research Contact
Criterion for success: 90% of clients referred to LTP-B to agree to be contacted for purposes of research.
Measured: Time -1
Participant Recruitment (2) - Participants Enrolled
Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.
Measured: Time -1
Participant Recruitment (3) Families Enrolled Per Month
Criterion for success: 1.8 families enrolled per month.
Measured: Time -1
Adherence to Intervention
Criterion for success: 90% of participants to complete all three main LTP-B sessions (Family assessment, videofeedback, check in)
Measured: Times 1, 2, 3
Retention: Post-Intervention
Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.
Measured: Time 3
Retention: Follow-Up
Criterion for success: 80% of participants to remain in study until the end of follow-up assessment.
Measured: Time 4
Retention: Brief Surveys
Criterion for success: 80% of participants to complete all brief surveys.
Measured: Time 1, 2, 5
Acceptability
Criterion for success: 80 % of participants reporting at least "agree" on indicators of attitude, burden, perceived effectiveness, and ethicality on an Implementation Acceptability Scale. Minimum score=7, maximum scores=35. Higher scores correspond to better outcomes.
Measured: Time 3, 4
Descriptive (no criterion for success): Behavioral Coding of Family Interactions (Frascarolo et al., 2018)
Family interactions will be behaviourally coded by trained coders based on the LTP Assessments (initial family assessment), using previously validated approaches (e.g., Frasarolo et al., 2018).
Measured: Week 1
Secondary outcomes (12)
Brief Dyadic Adjustment
Using the Brief Dyadic Adjustment Scale (DAS-4). Minimum score= 0, maximum score=21. Higher scores correspond to better outcomes.
Measured: Time 0, 1, 2, 3, 4, 5
Coparenting Relationship Quality
Using the Brief Coparenting Relationship Scale (Feinberg et al., 2012). Minimum score=0, maximum score=84. Higher scores correspond to better outcomes.
Measured: Time 0, 3, 4
Brief Coparenting Relationship Quality
Using the Subset of Brief Coparenting Relationship Quality Scale (Feinberg et al., 2012). Minimum score=0, maximum score=36. Higher scores correspond to better outcomes.
Measured: Time 1, 2, 5
Parent-Child Positivity
Using the 5-item parent-reported positivity subscale of the Parenting Practices Scale. Minimum score=5, maximum score=25. Higher scores correspond to better outcomes.
Measured: Time 0, 3, 4
Parent-Child Negativity
Using the 5-item parent-reported negativity subscale of the Parenting Practices Scale. Minimum score=5, maximum score=25. Higher scores correspond to worse outcomes.
Measured: Time 0, 3, 4
Sibling Relations
Using Parental Expectations and Perceptions of Children's Sibling Relationship Questionnaire (PEPC-SRQ). Minimum score=8 , maximum score=40. Higher scores correspond to better outcomes.
Measured: Time 0, 3, 4
Whole Family Functioning
Using 6-item Family Assessment Device (FAD). Minimum score=5, maximum score=20. Higher scores correspond to worse outcomes.
Measured: Time 0, 3, 4
Parent Mental Health
Using the Kessler Psychological Distress Scale (K10). Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.
Measured: Time 0, 3, 4
Brief Parent Mental Health
Using the Kessler Psychological Distress Scale (K6). Minimum score=6, maximum score=30. Higher scores correspond to worse outcomes.
Measured: Time 1, 2, 5
Child Emotional and Behavioural Problems (1) - (Children Ages 18 months to 3 years 11 months)
Scores will be standardized within each age group and used as a single outcome variable.
The Preschool Pediatric Symptom Checklist (PPSC-17): Minimum score=0, maximum score=36. Higher scores correspond to worse outcomes.
Measured: Time 0, 3, 4
Child Emotional and Behavioural Problems (2) - (Children Ages 4 to 18 years)
Scores will be standardized within each age group and used as a single outcome variable.
The Pediatric Symptom Checklist (PSC-17). Minimum score=0, maximum score=34. Higher scores correspond to worse outcomes.
Measured: Time 0, 3, 4
Examine Therapy Sessions
Examine content and process of all therapy sessions (including therapist and client behaviours) qualitatively for a select number of 'successful' and 'unsuccessful' cases, using a pragmatic case-series analysis (e.g., Liekmeier et al., 2021)
Measured: Weeks 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jun 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne, SickKids Centre for Community Mental Health (SKCCMH)
- Responsible party
- Principal investigator, Heather Prime, York University
- Investigators
- Heather Prime, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356247
- Sponsor's protocol ID
- 2022-050
- Acronym
- LTP-B
- Status last verified
- Jul 2022
- First submitted
- 22 Mar 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lausanne Trialogue Paradigm - Brief: A Family Systems Model to Address Child Mental Health in a Community Mental Health Setting
- ClinicalTrials.gov ID
- NCT05356247
- Acronym / sponsor ID
- LTP-B / 2022-050
- Conditions
- Parent-Child Relations, Family Relations, Internet-Based Intervention, Mental Health Issue, Behavioral Problem
- Keywords
- Child Mental Health, Family Systems, Coparenting, Single arm pre-post design, COVID-19 Family Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- University of Lausanne, SickKids Centre for Community Mental Health (SKCCMH)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 2 May 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.
The current study is a feasibility pilot of the Lausanne Trialogue Play paradigm Intervention - Brief (LTP-Brief), a family systems therapy implemented in a community mental health setting. We will study the ultrabrief, virtual therapy to assess the feasibility of a future pilot RCT. Feasibility metrics include resource, scientific, and management considerations, as well as an examination of pre-post change in future child and family outcomes of interest.
Detailed description
COVID-19 represents an acute crisis to children's mental health, with potential for long-term consequences. There is evidence for elevated mental health symptomatology in children since the start of the pandemic, with the emergence of stress-related disorders and the exacerbation of pre-existing disorders. Indeed, the pandemic has had detrimental effects on family life due to widespread job loss and financial insecurity, and increases to parental psychological distress, mental illness, and substance use. Social consequences of COVID-19 are expected to have cascading negative effects on child mental health symptoms. Thus, a COVID-19 family recovery program is critically needed, both during and after the pandemic, to manage the current mental health crisis in children and create cascading and sustainable effects for lifelong physical and mental health. The main goal of the the current study is to investigate feasibility of a future pilot and/or main RCT of a brief, virtual mental health treatment program for children and families designed to optimize reach of services. Specifically, the Lausanne Trialogue Play paradigm assessment is a semi-structured assessment of whole family interactions, with emphasis on the co-parenting relationship, which has been used extensively in research settings for assessment and consultative purposes. The current study will assess the feasibility of using the LTP in an assessment-as-treatment model. This brief treatment program, called the LTP-Brief intervention (LTP-B) will consist of a family play assessment (including an LTP assessment) with video feedback to caregivers as a method for promoting change in family interaction patterns. By targeting change across the family system, rather than focusing on specific child mental health symptoms directly, the model addresses upheaval of family life during COVID-19 and has potential to create sustainable improvements in family well-being within a short period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LTP-B Intervention | Experimental | Behavioral: Lausanne Trialogue Play BriefFamilies will take part in an online semi-structured assessment and video feedback paradigm of family interactions, with an emphasis on co-parenting and parent-child relations. |
Who may qualify
- Ages
- 0 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The sample will comprise of families referred to the outpatient mental health services at Sick Kids Center for Community Mental Health (SKCCMH), a non-profit children's mental health treatment centre in Toronto, ON, Canada.
- Participants will include children ages 0 months to 15.11 years old, and their caregivers, though the majority will fall in the range of 3- to 14-years-old.
- The first 25 families to be referred to the LTP-B service and who agree to participate in research will be included.
Key exclusion criteria (1 listed)
- No exclusion criteria beyond what is standard for the clinical service at SKCCMH.
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 |
|---|---|---|
| Lausanne Trialogue Play BriefAlso: LTP-BThe brief treatment program will consist of an LTP family assessment with video feedback to caregivers to address family interaction patterns and child mental health. Families will participate in four sessions conducted online using the Zoom for Healthcare platform. In the first session, families will engage in a family assessment in different groupings that will be recoded on zoom and used later in the treatment. In the second session, taking place one week later, families will take part in a mini assessment to learn more about the difficulties of the child. In the third session, the clinical team will share videos of the family assessment to the parents and discuss the families strengths, concerns, and goals for moving forward. In the fourth session, taking place one month after the third session, families will participate in a check-in session, debriefing the family assessment. | Behavioural | LTP-B Intervention |
Primary outcome
COVID-19-related Family Stressors
Time frame: Time 0, 3
Descriptive (no criterion for success): Family Stressor Scale. Minimum score=16, maximum score=48. Higher scores correspond to worse outcomes.
COVID-19-related Family Positive Adaptation
Time frame: Time 0, 3
Descriptive (no criterion for success): COVID-19 Family Positive Adaptation Scale. Minimum score=14, maximum score=42. Higher scores correspond to better outcomes.
Therapeutic Alliance
Time frame: Time 1, 2, 3, 5
Descriptive (no criterion for success): Working Alliance Inventory-Short Revised (WAI-SR). Minimum score=12, maximum score=60. Higher scores correspond to better outcomes.
Form Research-Clinical Partnership (1) - Clinical-Research Meetings
Time frame: Time -1 to end of study
Criterion for success: Meet once monthly throughout the course of the study.
Form Research-Clinical Partnership (2) - Protocol Development - a
Time frame: Time -1
Criterion for success: Administrative approval from SKCCMH for study (via approval of ethics approval).
Form Research-Clinical Partnership (3) - Protocol Development - b
Time frame: Time -1
Criterion for success: Submission of protocol for registration to clinicaltrials.gov and/or journal publications.
Research-Clinical Communication (1) - Clients Referred to LTP-B
Time frame: Time -1
Criterion for success: 95% of clients referred to LTP-B to be asked permission to be contacted by the research team.
Research-Clinical Communication (2) - Clients Transferred to Research Team
Time frame: Time -1
Criterion for success: 95% of clients that agree to research are transferred to the research team for contact.
Research-Clinical Communication (3) - Clinical Visits Shared
Time frame: Time -1 to end of study
Criterion for success: 95% of participants' scheduled clinical visits to be shared with the research team.
Research-Clinical Communication (4) - Videos Shared
Time frame: Time 1, 2, 3
Criterion for success: 95% of participant videos (previously consented) to be successfully shared with the research team.
Clinical Service Flow (1) - Clients Referred
Time frame: Time -1
Criterion for success: 3 families to be referred to the LTP-B per month.
Clinical Service Flow (2) - Service Provision
Time frame: Time -1
Criterion for success: 2 families to be seen by the LTP-B team per month.
Participant Recruitment (1) - Agree to Research Contact
Time frame: Time -1
Criterion for success: 90% of clients referred to LTP-B to agree to be contacted for purposes of research.
Participant Recruitment (2) - Participants Enrolled
Time frame: Time -1
Criterion for success: 90% of clients participating in LTP-B to enroll in the research study.
Participant Recruitment (3) Families Enrolled Per Month
Time frame: Time -1
Criterion for success: 1.8 families enrolled per month.
Adherence to Intervention
Time frame: Times 1, 2, 3
Criterion for success: 90% of participants to complete all three main LTP-B sessions (Family assessment, videofeedback, check in)
Retention: Post-Intervention
Time frame: Time 3
Criterion for success: 90% of participants to remain in study until the end of post-intervention assessment.
Retention: Follow-Up
Time frame: Time 4
Criterion for success: 80% of participants to remain in study until the end of follow-up assessment.
Retention: Brief Surveys
Time frame: Time 1, 2, 5
Criterion for success: 80% of participants to complete all brief surveys.
Acceptability
Time frame: Time 3, 4
Criterion for success: 80 % of participants reporting at least "agree" on indicators of attitude, burden, perceived effectiveness, and ethicality on an Implementation Acceptability Scale. Minimum score=7, maximum scores=35. Higher scores correspond to better outcomes.
Descriptive (no criterion for success): Behavioral Coding of Family Interactions (Frascarolo et al., 2018)
Time frame: Week 1
Family interactions will be behaviourally coded by trained coders based on the LTP Assessments (initial family assessment), using previously validated approaches (e.g., Frasarolo et al., 2018).
12 secondary outcomes
Brief Dyadic Adjustment
Time frame: Time 0, 1, 2, 3, 4, 5
Coparenting Relationship Quality
Time frame: Time 0, 3, 4
Brief Coparenting Relationship Quality
Time frame: Time 1, 2, 5
Parent-Child Positivity
Time frame: Time 0, 3, 4
Parent-Child Negativity
Time frame: Time 0, 3, 4
Sibling Relations
Time frame: Time 0, 3, 4
Whole Family Functioning
Time frame: Time 0, 3, 4
Parent Mental Health
Time frame: Time 0, 3, 4
Brief Parent Mental Health
Time frame: Time 1, 2, 5
Child Emotional and Behavioural Problems (1) - (Children Ages 18 months to 3 years 11 months)
Time frame: Time 0, 3, 4
Child Emotional and Behavioural Problems (2) - (Children Ages 4 to 18 years)
Time frame: Time 0, 3, 4
Examine Therapy Sessions
Time frame: Weeks 1, 2, 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- 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.
Diane Philipps, PhD contact
Heather Prime, PhD principal investigator
York 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 Lausanne Trialogue Play Brief in people with Parent-Child Relations and Family Relations, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 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 12 Jul 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Prime, PhD (4168197331, hprime@yorku.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19-related Family Stressors (time frame: Time 0, 3). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.