Stress, PsychologicalNCT05264415
Intergenerational Transmission of Traumatic Stress
A study testing Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) and Parenting Education Website in people with Stress, Psychological and Stress Disorders, Traumatic, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Stress, Psychological, Stress Disorders, Traumatic, Emotion Regulation
- What is being tested?
- Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) and Parenting Education Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 4 Nov 2024
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent/caregiver (must be legal guardian) of a 3- to 6-year-old child
- Child must cohabitate with the parent/caregiver
- Parent/caregiver participant must have experienced some form of interpersonal trauma during their own childhood (e.g., abuse, neglect, witnessing domestic violence)
- Parent/caregiver must be English-speaking
- Parent/caregiver must have access to internet and Webcam
Who cannot join
- Does not meet inclusion criteria
- Parent/legal guardian does not want the child to participate in the study
- Significant neurological disorder (included in pre-screening protocol)
- Active psychosis/mania (as assessed by staff)
- Significant child developmental delays (as assessed by staff)
- Families excluded from the study will be provided with a list of online and/or community resources.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
About this study
Official title: Interrupting the Intergenerational Transmission of Traumatic Stress: Identifying Parental Targets for Intervention by Looking Under the Skin
Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. The study employs neurophysiological methods (electroencephalogram; EEG) to address some of the challenges inherent in the study of emotion (particularly in trauma-exposed individuals) and to identify potential biomarkers of traumatic stress and response to intervention.
Read the detailed description
This research study consists of a randomized controlled trial of 60 families of preschool-aged children in which a parent/caregiver has their own history of childhood interpersonal trauma or loss.
Parent/caregiver participants and their preschool-aged child will participate in two phases of assessment (baseline/Time 1 and follow-up/Time 2). Each phase of assessment will include parent/caregiver participant completion of self-report questionnaire measures, a parent-child interaction task (which will be video-recorded for later behavioral coding) and a parent EEG assessment. After the Time 1 (T1) assessments, participants will be randomized to either the FOCUS-Early Childhood Program group (n = 30; experimental group) or the parent education curriculum website group (n = 30; active comparator group).
The T2 assessment phase will begin at 3-months post-baseline. The FOCUS-EC Program is an 8-week program, so families should have completed the program by 3 months post-baseline. In the event that a family that was randomized to the FOCUS-EC Program group has not completed the program by the 3-month mark, the T2 assessment will be initiated once the program has been completed (up to 6 months post-baseline).
- Conditions
- Stress, Psychological, Stress Disorders, Traumatic, Emotion Regulation, Behavior, Child, Emotional Stress, Trauma, Psychological
- Being tested
- Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC), Parenting Education Website
- Keywords
- Resilience, Families, Parents, Children, Preschooler, Intervention
- Medical subject headings
- Stress, Psychological, Stress Disorders, Traumatic, Emotional Regulation, Child Behavior, Psychological Trauma, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)Behavioural
Trauma-informed, family-centered, skill-building preventive intervention for families with preschool-aged children.
Parenting Education WebsiteOther
A website providing parenting education resources in four primary domains relevant for families with preschool-aged children (parenting, child development, transitions, and self-care).
| Study group | Role | What they receive |
|---|---|---|
| Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC) | Experimental | FOCUS-EC is a trauma-informed, family-level, skill building program that provides developmental guidance, parent education, and key resilience skills that promote positive individual and family coping (including emotional regulation, problem solving, goal setting, communication, and management of trauma \& loss reminders), which foster parent-child and family cohesion. It is delivered in approximately 8 weekly sessions (including approximately six 60-minute sessions with parent/caregivers only, and two 30-60 minute sessions with children and parent/caregivers together). Each session is structured with a check-in, review of the previous week's "home activity," new skills-based activity and discussion, selection of a new "home activity," and a closing check-out. FOCUS-EC promotes parenting skills and more cohesive family relationships in two key phases: 1) creating a family timeline and 2) enhancing parent-child interactions. Receives: Behavioral: Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) |
| Parenting Education Website | Active comparator | The Parenting Education Website includes information and high-quality parenting resources covering topics such as typical child development, common child reactions to family stress and transitions, play, positive parenting strategies, and the importance of self-care. Receives: Other: Parenting Education Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in observed parenting behaviors during standardized parent-child interaction tasks
Coded based on previously established parent-child behavioral coding systems (Deater-Deckard, 2000; Deater-Deckard, Pylas, \& Petrill, 1997; Dix et al., 2004; Murphy, Boyd-Soissan, et al., 2017), including codes for positive parenting behaviors (e.g., praise, sensitivity, positive affect expressions), negative parenting behaviors (e.g., criticism, intrusiveness, harshness, negative affect expressions), and responses to children's negative emotion expressions (e.g., emotion coaching, validation, suppression, minimization).
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in self-reported parenting behaviors as measured by the Multidimensional Assessment of Parenting Scale (MAPS)
The Multidimensional Assessment of Parenting Scale (MAPS) is a self-report questionnaire of parenting behaviors. This study will administer the 30 items corresponding to subscales that represent the following aspects of parenting behavior:
- proactive parenting
- positive reinforcement
- warmth
- supportiveness
- hostility
- lax control
The scale is scored such that higher scores indicate a higher degree of that type of parenting (e.g., higher scores on the positive reinforcement subscale indicate greater use of positive reinforcement).
Each subscale:
Minimum possible score: 1 Maximum possible score: 5
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in posttraumatic stress disorder symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
The Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5) is a well-established, 20-item questionnaire of posttraumatic stress symptoms. Higher scores indicate higher levels of posttraumatic stress symptoms.
Minimum possible score: 0 Maximum possible score: 80
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Secondary outcomes (10)
Change in Emotion Regulation Questionnaire (ERQ)
The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report questionnaire that assesses emotion regulation strategies of cognitive reappraisal and expressive suppression, with higher scores indicating greater use of those strategies.
Minimum possible score: 1 Maximum possible score: 7
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Parental Feelings Inventory (PFI)
The Parental Feelings Inventory (PFI) is a 31-item self-report questionnaire that assesses parents' experience of specific emotions in the parenting context (Bradley et al., 2013). Higher scores represent greater experience of each type of emotion in the parenting role within the past month.
Minimum possible score: 1 Maximum possible score: 7
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Parental Emotion Regulation Inventory-2 (PERI-2)
The Parental Emotion Regulation Inventory-2 (PERI-2) is a self-report questionnaire that assesses coping and emotion regulation strategies used within the parenting context (Lorber et al., 2017). The scale includes 23 items corresponding to subscales that represent the following aspects of emotion regulation:
- reappraisal
- suppression
- capitulation
- escape
The scale is scored such that higher scores indicate a higher degree of that type of strategy (e.g., higher scores on the reappraisal subscale indicate greater use of reappraisal).
Minimum possible score: 1 Maximum possible score: 7
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Coping with Children's Negative Emotions Scale (CCNES)
The Coping with Children's Negative Emotions Scale (CCNES) is an 82-item self-report questionnaire that assesses parents' responses to children's displays of negative emotions (e.g., expressive encouragement, problem solving, punishment, minimization). Higher scores reflect higher use of that type of response (e.g., higher score on expressive encouragement subscale indicates higher use of expressive encouragement responses).
Minimum possible score: 1 Maximum possible score: 7
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is a well-established, 8-item scale of depression symptoms, with higher total scores indicating higher levels of depression symptoms.
Minimum possible score: 0 Maximum possible score: 24
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
The Generalized Anxiety Disorder-7 Questionnaire (GAD-7) is a well-established, 7-item scale of anxiety symptoms, with higher total scores indicating higher levels of anxiety symptoms.
Minimum possible score: 0 Maximum possible score: 21
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Parenting Stress Index-Short Form 4
The Parenting Stress Index-Short Form 4 (PSI-SF) is a 36-item self-report questionnaire of three dimensions of parenting stress (parental distress, parent-child dysfunctional interaction, and difficult child). Higher scores indicate higher levels of parenting stress.
Subscales:
Minimum possible score: 12 Maximum possible score: 60
Total Score:
Minimum possible score: 36 Maximum possible score: 180
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Eyberg Child Behavior Inventory
The Eyberg Child Behavior Inventory (ECBI) is a 36-item parent/caregiver-report questionnaire measure of children's behavior problems that obtains information about the frequency of problem behaviors (Intensity subscale; higher scores indicate greater intensity) and whether or not the behavior is problematic for the parent (Problem subscale; higher scores indicate greater problem).
Behavior intensity:
Minimum possible score: 36 Maximum possible score: 252
Problem behavior:
Minimum possible score: 0 Maximum possible score: 36
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Preschool Feelings Checklist
The Preschool Feelings Checklist is a 16-item parent/caregiver-report questionnaire measure of children's depressive symptoms. Higher scores indicate higher depression symptoms.
Minimum possible score: 0 Maximum possible score: 16
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Spence Child Anxiety Scale - Preschool Version
The Spence Child Anxiety Scale - Preschool Version is a 34-item parent/caregiver-report questionnaire measure of children's anxiety symptoms. Higher scores indicate higher anxiety symptoms.
Minimum possible score: 0 Maximum possible score: 112
Measured: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start6 Oct 2021
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nastassia Hajal, University of California, Los Angeles
- Investigators
- Nastassia Hajal, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264415
- Sponsor's protocol ID
- KHD097277A
- Other IDs
- 1K08HD097277-01A1
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrupting the Intergenerational Transmission of Traumatic Stress: Identifying Parental Targets for Intervention by Looking Under the Skin
- ClinicalTrials.gov ID
- NCT05264415
- Acronym / sponsor ID
- KHD097277A
- Conditions
- Stress, Psychological, Stress Disorders, Traumatic, Emotion Regulation, Behavior, Child, Emotional Stress, Trauma, Psychological
- Keywords
- Resilience, Families, Parents, Children, Preschooler, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 3 Mar 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.
Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. The study employs neurophysiological methods (electroencephalogram; EEG) to address some of the challenges inherent in the study of emotion (particularly in trauma-exposed individuals) and to identify potential biomarkers of traumatic stress and response to intervention.
Detailed description
This research study consists of a randomized controlled trial of 60 families of preschool-aged children in which a parent/caregiver has their own history of childhood interpersonal trauma or loss.
Parent/caregiver participants and their preschool-aged child will participate in two phases of assessment (baseline/Time 1 and follow-up/Time 2). Each phase of assessment will include parent/caregiver participant completion of self-report questionnaire measures, a parent-child interaction task (which will be video-recorded for later behavioral coding) and a parent EEG assessment. After the Time 1 (T1) assessments, participants will be randomized to either the FOCUS-Early Childhood Program group (n = 30; experimental group) or the parent education curriculum website group (n = 30; active comparator group).
The T2 assessment phase will begin at 3-months post-baseline. The FOCUS-EC Program is an 8-week program, so families should have completed the program by 3 months post-baseline. In the event that a family that was randomized to the FOCUS-EC Program group has not completed the program by the 3-month mark, the T2 assessment will be initiated once the program has been completed (up to 6 months post-baseline).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC) | Experimental | Behavioral: Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)FOCUS-EC is a trauma-informed, family-level, skill building program that provides developmental guidance, parent education, and key resilience skills that promote positive individual and family coping (including emotional regulation, problem solving, goal setting, communication, and management of trauma \& loss reminders), which foster parent-child and family cohesion. It is delivered in approximately 8 weekly sessions (including approximately six 60-minute sessions with parent/caregivers only, and two 30-60 minute sessions with children and parent/caregivers together). Each session is structured with a check-in, review of the previous week's "home activity," new skills-based activity and discussion, selection of a new "home activity," and a closing check-out. FOCUS-EC promotes parenting skills and more cohesive family relationships in two key phases: 1) creating a family timeline and 2) enhancing parent-child interactions. |
| Parenting Education Website | Active comparator | Other: Parenting Education WebsiteThe Parenting Education Website includes information and high-quality parenting resources covering topics such as typical child development, common child reactions to family stress and transitions, play, positive parenting strategies, and the importance of self-care. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parent/caregiver (must be legal guardian) of a 3- to 6-year-old child
- Child must cohabitate with the parent/caregiver
- Parent/caregiver participant must have experienced some form of interpersonal trauma during their own childhood (e.g., abuse, neglect, witnessing domestic violence)
- Parent/caregiver must be English-speaking
- Parent/caregiver must have access to internet and Webcam
Key exclusion criteria (6 listed)
- Does not meet inclusion criteria
- Parent/legal guardian does not want the child to participate in the study
- Significant neurological disorder (included in pre-screening protocol)
- Active psychosis/mania (as assessed by staff)
- Significant child developmental delays (as assessed by staff)
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 |
|---|---|---|
| Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC)Trauma-informed, family-centered, skill-building preventive intervention for families with preschool-aged children. | Behavioural | Families Over-Coming Under Stress-Early Childhood Program (FOCUS-EC) |
| Parenting Education WebsiteA website providing parenting education resources in four primary domains relevant for families with preschool-aged children (parenting, child development, transitions, and self-care). | Other | Parenting Education Website |
Primary outcome
Change in observed parenting behaviors during standardized parent-child interaction tasks
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Coded based on previously established parent-child behavioral coding systems (Deater-Deckard, 2000; Deater-Deckard, Pylas, \& Petrill, 1997; Dix et al., 2004; Murphy, Boyd-Soissan, et al., 2017), including codes for positive parenting behaviors (e.g., praise, sensitivity, positive affect expressions), negative parenting behaviors (e.g., criticism, intrusiveness, harshness, negative affect expressions), and responses to children's negative emotion expressions (e.g., emotion coaching, validation, suppression, minimization).
Change in self-reported parenting behaviors as measured by the Multidimensional Assessment of Parenting Scale (MAPS)
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
The Multidimensional Assessment of Parenting Scale (MAPS) is a self-report questionnaire of parenting behaviors. This study will administer the 30 items corresponding to subscales that represent the following aspects of parenting behavior: * proactive parenting * positive reinforcement * warmth * supportiveness * hostility * lax control The scale is scored such that higher scores indicate a higher degree of that type of parenting (e.g., higher scores on the positive reinforcement subscale indicate greater use of positive reinforcement). Each subscale: Minimum possible score: 1 Maximum possible score: 5
Change in posttraumatic stress disorder symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
The Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5) is a well-established, 20-item questionnaire of posttraumatic stress symptoms. Higher scores indicate higher levels of posttraumatic stress symptoms. Minimum possible score: 0 Maximum possible score: 80
10 secondary outcomes
Change in Emotion Regulation Questionnaire (ERQ)
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Parental Feelings Inventory (PFI)
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Parental Emotion Regulation Inventory-2 (PERI-2)
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Coping with Children's Negative Emotions Scale (CCNES)
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Patient Health Questionnaire-8 (PHQ-8)
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Parenting Stress Index-Short Form 4
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Eyberg Child Behavior Inventory
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Preschool Feelings Checklist
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Change in Spence Child Anxiety Scale - Preschool Version
Time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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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.
Nastassia Hajal, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families OverComing Under Stress (FOCUS) for Early Childhood (FOCUS-EC) and Parenting Education Website in people with Stress, Psychological and Stress Disorders, Traumatic, run by University of California, Los Angeles 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 5 inclusion and 6 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 29 Nov 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?
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 in observed parenting behaviors during standardized parent-child interaction tasks (time frame: Time 1 (baseline assessment) and Time 2 (3-months post-baseline)). The study lists 3 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 29 Nov 2024.