Child WellbeingCPRNCT06840431
Randomized Control Trial of the Co-Parenting for Resilience Program
A study testing in-person condition, online condition and self-help condition in people with Child Wellbeing, run by Oklahoma State University at 1 site in United States.
Trial summary
Because parental divorce has been linked to a significant increase in mental health diagnoses among children, it is important to develop effective interventions that reduce the negative impact of divorce on children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Wellbeing
- What is being tested?
- in-person condition, online condition and self-help condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One adult member of a dyad filing for a divorce or legal separation (e.g., non-married couples) in Oklahoma County with a biological minor child aged 4-10,
- Being an English or Spanish speaker,
- Having internet access necessary for the online group (necessary for this randomized trial.
- In the event participants have more than one child, they will be asked to report on their oldest child with the person they are divorcing who is age 10 or under. Focus on the oldest child counterbalances the age distribution of children expected per our preliminary data, thereby facilitating a test of age differences in treatment effects.
Who cannot join
- Parents under the age of 18,
- Parents who do not consent to randomization,
- Parents who are illiterate.
- Only one member of the dyad will be allowed in the study.
- We also exclude parents for whom the target child is not the biological child of both parents. Stepfamilies, adoptive families, grandparents raising grandchildren, and other family types have dynamics not directly comparable to families with two biological parents and is beyond the scope of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Because parental divorce has been linked to a significant increase in mental health diagnoses among children, it is important to develop effective interventions that reduce the negative impact of divorce on children. This study assesses the efficacy of the Co-Parenting for Resilience (CPR) resilience program by randomly assigning divorcing individuals to three different forms of the intervention to test whether one or both of versions of CPR are better than reading a self-help book, and whether an in-person version of CPR is more effective than an online version. The three conditions or versions are: 1) an in-person version of CPR taught by a trained non-clinician, 2) an asynchronous fully online version of CPR, and 3) a group that simply reads a self-help book and responds to a knowledge check to ensure the material was read.
Read the detailed description
Reducing the effects of parental divorce on children is a clear but often overlooked public health issue. Nearly 44% of the 66 million children living in the U.S. will experience their parents' divorce or separation by age 15. Because children whose parents divorce are more likely to develop social, emotional, behavioral and physical problems and have lower academic performance than their peers from intact families; and because more children of divorce (25%) are diagnosed with mental illness compared to children in the general population (10%), addressing the negative impacts of divorce on children is a national imperative.
Parental management of the divorce process has been shown to be key in determining child adjustment, with greater mismanagement and conflict associated with multiple negative outcomes for children. Divorce can create considerable turmoil in people's lives leading some parents to mishandle their own emotions. Highly emotional parents often place their children in the middle of their conflict, overly rely on children to meet their own emotional needs, or practice avoidance coping through alcohol and drugs or by otherwise abandoning their children. Divorce education programs claiming to help parents ameliorate the effects of divorce on children abound in all 50 states; and over half of states mandate attendance by statute. However, recent reviews reveal major weaknesses in program development and evaluation, such as: (a) few programs are guided by theories of behavior change and only seek to increase knowledge; (b) the majority of programs have not been evaluated, and those that have lack methodological rigor; (c) child outcomes are rarely assessed either directly or indirectly through parent report, (d) important moderators to help determine for whom the program is effective (e.g., parent gender and ethnicity, low- vs. high-conflict couples, reasons for divorce) have not been explored; and (e) although online programs proliferated during COVID-19, they have largely not been tested. Addressing these and other weaknesses is critical to making scientific progress in the field and to developing programs with demonstrated efficacy in helping the millions of parents and children avoid the more severe effects of divorce.
The Co-Parenting for Resilience (CPR) program innovatively merges research from Family Therapy and Prevention Science to address many of the above-mentioned weaknesses. CPR is a 4-hour psychoeducational intervention that draws from empirically supported approaches such as Brief Strategic Family Therapy, Motivational Interviewing, and Family Stress Theory, and uses a combination of instruction, interactive activities, and guided reflections to promote the deep learning and paradigm shifts that aid in changing maladaptive cognitions and in promoting effective parenting and improved child outcomes. Initial findings from a pilot study suggest that CPR reduces parent reports of conflict and stress and increases parental collaboration, hope, and parent reports of child adjustment. These findings, however, were based on a quasi-experimental design with a non-equivalent control group. The proposed R15 project advances the science by leveraging a long-standing partnership with the Oklahoma County District Court to conduct a 3-arm RCT that will accomplish three specific aims:
- Determine the relative efficacy of the online and in-person versions of CPR to improve child post-divorce adjustment compared to each other and to a bibliotherapy control group at 3- and 12-month follow-ups.
- Test paths from the online and in-person versions of CPR to child adjustment via parenting competencies.
- Identify moderators of the effectiveness of in-person and online formats of CPR such as parent gender, ethnicity, and level and type of conflict between divorcing partners.
Primary hypotheses tested are that the effects of CPR on child post-divorce adjustment will: (H1) be higher in both CPR conditions relative to the control group; (H2) not differ between the two CPR conditions; (H3) be mediated by parenting competencies, and (H4) there will be moderation by level and type of conflict.
We will randomly assign 300 unique individuals (not couples) who have filed for divorce to one of the three arms (n=100 each arm). Data will be collected at three timepoints: baseline (pre-intervention), at 3-months to test for program efficacy and mediation, and at a 12-month follow-up controlling for baseline. Participants will be parents of either gender who are filing for divorce with a child from 4-10 years old.
Per the R15 mechanism, this project proposes three objectives: (1) to conduct a small-scale research project whose aims address a significant public health issue, the physical and mental health of divorcing parents and their children; (2) to expose graduate and undergraduate students to different phases of the research process; and (3) to expand institutional research capacity.
The project will innovatively: 1) leverage the court system to rigorously answer questions significant to science and to divorcing families, 2) test an online version of the CPR program that will benefit an underserved rural population, 3) inform further program development by identifying key program moderators, and 4) provide critical empirical evidence for the dissemination of the CPR program to other states.
- Conditions
- Child Wellbeing
- Being tested
- in-person condition, online condition, self-help condition
- Keywords
- divorce, child wellbeing, co-parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-person conditionBehavioural
participants will receive program components in a classroom setting with a trained non-clinical facilitator.
online conditionBehavioural
Participants will receive program components in an asynchronous online format.
self-help conditionBehavioural
Participants will read a self-help book on how to manage their divorce and take a quiz to ensure that the book has been read.
| Study group | Role | What they receive |
|---|---|---|
| In person condition | Experimental | This condition tests program effects when delivered by a trained non-clinical facilitator. Receives: Behavioral: in-person condition |
| online condition | Experimental | This condition tests program effects when the program is delivered asynchronously online Receives: Behavioral: online condition |
| Self-help book with quiz | Placebo comparator | This condition serves as a placebo control comparing the intervention components to a knowledge only condition. Receives: Behavioral: self-help condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties Questionnaire (SDQ)
The SDQ is a widely used measure consisting of 25 items that make up five subscales on which parents report their child's emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior. The SDQ has been normed on children from 4-17 years of age and provides a total child difficulty score and a score for each of the five subscales. For our primary analyses of child adjustment, we will use the total child difficulty score.
Measured: Baseline, 3-month follow-up, and 12-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 posted21 Feb 2025
- Study start1 Jul 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Child WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ronald Cox, Oklahoma State University
- Investigators
- Ronald B Cox, PhD, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840431
- Sponsor's protocol ID
- Oklahoma State University
- Other IDs
- 1R15HD112895-01
- Acronym
- CPR
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing individualized data rather than aggregate data would be a breach of confidentiality and is not permitted by our IRB.
Publications
Cox, R.B., et al., Hope, Stress, and Post-Divorce Child Adjustment: Development and Evaluation of the Co-Parenting for Resilience Program. Journal of Divorce & Remarriage, 2021. 62(2): p. 144-163.
Hill, R., Generic features of families under stress. Social Casework, 1958. 39(2-3): p. 139-150.
Hill, R., Families under stress: Adjustment to the crises of war separation and return. 1949.
Miller, W.R. and S. Rollnick, Motivational interviewing: Helping people change. 2012: Guilford press.
Fisch, R., J. Weakland, and L. Segal, The tactics of change: Doing therapy briefly. 1982, San Francisco: Jossey-Bass.
Sigal A, Sandler I, Wolchik S, Braver S. Do Parent Education Programs Promote Healthy Post-Divorce Parenting? Critical Distinctions and a Review of the Evidence. Fam Court Rev. 2011 Jan;49(1):120-139. doi: 10.1111/j.1744-1617.2010.01357.x.
PubMed 21552360Kierstead, S., Parent education programs in family courts: Balancing autonomy and state intervention. Family Court Review, 2011. 49(1): p. 140-154.
Pollet, S.L. and M. Lombreglia, A nationwide survey of mandatory parent education. Family Court Review, 2008. 46(2): p. 375-394.
Dunn J, Davies LC, O'Connor TG, Sturgess W. Family lives and friendships: the perspectives of children in step-, single-parent, and nonstep families. J Fam Psychol. 2001 Jun;15(2):272-87.
PubMed 11458633Sandler I, Gunn H, Mazza G, Tein JY, Wolchik S, Berkel C, Jones S, Porter M. Effects of a Program to Promote High Quality Parenting by Divorced and Separated Fathers. Prev Sci. 2018 May;19(4):538-548. doi: 10.1007/s11121-017-0841-x.
PubMed 28913663Amato, P.R., The consequences of divorce for adults and children: An update. Drustvena istrazivanja, 2014. 23(1): p. 5-24.
Andersson, G., E. Thomson, and A. Duntava, Life-table representations of family dynamics in the 21st century. Demographic Research, 2017. 37: p. 1081-1230.
Vezzetti VC. New approaches to divorce with children: A problem of public health. Health Psychol Open. 2016 Nov 15;3(2):2055102916678105. doi: 10.1177/2055102916678105. eCollection 2016 Jul.
PubMed 28070408
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of the Co-Parenting for Resilience Program
- ClinicalTrials.gov ID
- NCT06840431
- Acronym / sponsor ID
- CPR / Oklahoma State University
- Conditions
- Child Wellbeing
- Keywords
- divorce, child wellbeing, co-parenting
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Feb 2025 (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.
Because parental divorce has been linked to a significant increase in mental health diagnoses among children, it is important to develop effective interventions that reduce the negative impact of divorce on children. This study assesses the efficacy of the Co-Parenting for Resilience (CPR) resilience program by randomly assigning divorcing individuals to three different forms of the intervention to test whether one or both of versions of CPR are better than reading a self-help book, and whether an in-person version of CPR is more effective than an online version. The three conditions or versions are: 1) an in-person version of CPR taught by a trained non-clinician, 2) an asynchronous fully online version of CPR, and 3) a group that simply reads a self-help book and responds to a knowledge check to ensure the material was read.
Detailed description
Reducing the effects of parental divorce on children is a clear but often overlooked public health issue. Nearly 44% of the 66 million children living in the U.S. will experience their parents' divorce or separation by age 15. Because children whose parents divorce are more likely to develop social, emotional, behavioral and physical problems and have lower academic performance than their peers from intact families; and because more children of divorce (25%) are diagnosed with mental illness compared to children in the general population (10%), addressing the negative impacts of divorce on children is a national imperative.
Parental management of the divorce process has been shown to be key in determining child adjustment, with greater mismanagement and conflict associated with multiple negative outcomes for children. Divorce can create considerable turmoil in people's lives leading some parents to mishandle their own emotions. Highly emotional parents often place their children in the middle of their conflict, overly rely on children to meet their own emotional needs, or practice avoidance coping through alcohol and drugs or by otherwise abandoning their children. Divorce education programs claiming to help parents ameliorate the effects of divorce on children abound in all 50 states; and over half of states mandate attendance by statute. However, recent reviews reveal major weaknesses in program development and evaluation, such as: (a) few programs are guided by theories of behavior change and only seek to increase knowledge; (b) the majority of programs have not been evaluated, and those that have lack methodological rigor; (c) child outcomes are rarely assessed either directly or indirectly through parent report, (d) important moderators to help determine for whom the program is effective (e.g., parent gender and ethnicity, low- vs. high-conflict couples, reasons for divorce) have not been explored; and (e) although online programs proliferated during COVID-19, they have largely not been tested. Addressing these and other weaknesses is critical to making scientific progress in the field and to developing programs with demonstrated efficacy in helping the millions of parents and children avoid the more severe effects of divorce.
The Co-Parenting for Resilience (CPR) program innovatively merges research from Family Therapy and Prevention Science to address many of the above-mentioned weaknesses. CPR is a 4-hour psychoeducational intervention that draws from empirically supported approaches such as Brief Strategic Family Therapy, Motivational Interviewing, and Family Stress Theory, and uses a combination of instruction, interactive activities, and guided reflections to promote the deep learning and paradigm shifts that aid in changing maladaptive cognitions and in promoting effective parenting and improved child outcomes. Initial findings from a pilot study suggest that CPR reduces parent reports of conflict and stress and increases parental collaboration, hope, and parent reports of child adjustment. These findings, however, were based on a quasi-experimental design with a non-equivalent control group. The proposed R15 project advances the science by leveraging a long-standing partnership with the Oklahoma County District Court to conduct a 3-arm RCT that will accomplish three specific aims:
- Determine the relative efficacy of the online and in-person versions of CPR to improve child post-divorce adjustment compared to each other and to a bibliotherapy control group at 3- and 12-month follow-ups.
- Test paths from the online and in-person versions of CPR to child adjustment via parenting competencies.
- Identify moderators of the effectiveness of in-person and online formats of CPR such as parent gender, ethnicity, and level and type of conflict between divorcing partners.
Primary hypotheses tested are that the effects of CPR on child post-divorce adjustment will: (H1) be higher in both CPR conditions relative to the control group; (H2) not differ between the two CPR conditions; (H3) be mediated by parenting competencies, and (H4) there will be moderation by level and type of conflict.
We will randomly assign 300 unique individuals (not couples) who have filed for divorce to one of the three arms (n=100 each arm). Data will be collected at three timepoints: baseline (pre-intervention), at 3-months to test for program efficacy and mediation, and at a 12-month follow-up controlling for baseline. Participants will be parents of either gender who are filing for divorce with a child from 4-10 years old.
Per the R15 mechanism, this project proposes three objectives: (1) to conduct a small-scale research project whose aims address a significant public health issue, the physical and mental health of divorcing parents and their children; (2) to expose graduate and undergraduate students to different phases of the research process; and (3) to expand institutional research capacity.
The project will innovatively: 1) leverage the court system to rigorously answer questions significant to science and to divorcing families, 2) test an online version of the CPR program that will benefit an underserved rural population, 3) inform further program development by identifying key program moderators, and 4) provide critical empirical evidence for the dissemination of the CPR program to other states.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In person condition | Experimental | Behavioral: in-person conditionThis condition tests program effects when delivered by a trained non-clinical facilitator. |
| online condition | Experimental | Behavioral: online conditionThis condition tests program effects when the program is delivered asynchronously online |
| Self-help book with quiz | Placebo comparator | Behavioral: self-help conditionThis condition serves as a placebo control comparing the intervention components to a knowledge only condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- One adult member of a dyad filing for a divorce or legal separation (e.g., non-married couples) in Oklahoma County with a biological minor child aged 4-10,
- Being an English or Spanish speaker,
- Having internet access necessary for the online group (necessary for this randomized trial.
- In the event participants have more than one child, they will be asked to report on their oldest child with the person they are divorcing who is age 10 or under. Focus on the oldest child counterbalances the age distribution of children expected per our preliminary data, thereby facilitating a test of age differences in treatment effects.
Key exclusion criteria (5 listed)
- Parents under the age of 18,
- Parents who do not consent to randomization,
- Parents who are illiterate.
- Only one member of the dyad will be allowed in the study.
- We also exclude parents for whom the target child is not the biological child of both parents. Stepfamilies, adoptive families, grandparents raising grandchildren, and other family types have dynamics not directly comparable to families with two biological parents and is beyond the scope of this study.
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 |
|---|---|---|
| in-person conditionparticipants will receive program components in a classroom setting with a trained non-clinical facilitator. | Behavioural | In person condition |
| online conditionParticipants will receive program components in an asynchronous online format. | Behavioural | online condition |
| self-help conditionParticipants will read a self-help book on how to manage their divorce and take a quiz to ensure that the book has been read. | Behavioural | Self-help book with quiz |
Primary outcome
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline, 3-month follow-up, and 12-month follow-up
The SDQ is a widely used measure consisting of 25 items that make up five subscales on which parents report their child's emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior. The SDQ has been normed on children from 4-17 years of age and provides a total child difficulty score and a score for each of the five subscales. For our primary analyses of child adjustment, we will use the total child difficulty score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- BackgroundCox, R.B., et al., Hope, Stress, and Post-Divorce Child Adjustment: Development and Evaluation of the Co-Parenting for Resilience Program. Journal of Divorce & Remarriage, 2021. 62(2): p. 144-163.
- BackgroundHill, R., Generic features of families under stress. Social Casework, 1958. 39(2-3): p. 139-150.
- BackgroundHill, R., Families under stress: Adjustment to the crises of war separation and return. 1949.
- BackgroundMiller, W.R. and S. Rollnick, Motivational interviewing: Helping people change. 2012: Guilford press.
- BackgroundFisch, R., J. Weakland, and L. Segal, The tactics of change: Doing therapy briefly. 1982, San Francisco: Jossey-Bass.
- Background: PubMed 21552360Sigal A, Sandler I, Wolchik S, Braver S. Do Parent Education Programs Promote Healthy Post-Divorce Parenting? Critical Distinctions and a Review of the Evidence. Fam Court Rev. 2011 Jan;49(1):120-139. doi: 10.1111/j.1744-1617.2010.01357.x.
- BackgroundKierstead, S., Parent education programs in family courts: Balancing autonomy and state intervention. Family Court Review, 2011. 49(1): p. 140-154.
- BackgroundPollet, S.L. and M. Lombreglia, A nationwide survey of mandatory parent education. Family Court Review, 2008. 46(2): p. 375-394.
- Background: PubMed 11458633Dunn J, Davies LC, O'Connor TG, Sturgess W. Family lives and friendships: the perspectives of children in step-, single-parent, and nonstep families. J Fam Psychol. 2001 Jun;15(2):272-87.
- Background: PubMed 28913663Sandler I, Gunn H, Mazza G, Tein JY, Wolchik S, Berkel C, Jones S, Porter M. Effects of a Program to Promote High Quality Parenting by Divorced and Separated Fathers. Prev Sci. 2018 May;19(4):538-548. doi: 10.1007/s11121-017-0841-x.
- BackgroundAmato, P.R., The consequences of divorce for adults and children: An update. Drustvena istrazivanja, 2014. 23(1): p. 5-24.
- BackgroundAndersson, G., E. Thomson, and A. Duntava, Life-table representations of family dynamics in the 21st century. Demographic Research, 2017. 37: p. 1081-1230.
- Individual participant dataSharing planned: No. Sharing individualized data rather than aggregate data would be a breach of confidentiality and is not permitted by our IRB.
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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.
Ronald B Cox, PhD principal investigator
Oklahoma State 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 in-person condition, online condition and self-help condition in people with Child Wellbeing, run by Oklahoma State 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 5 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: enrolling by invitation, as of the sponsor's last update on 4 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Strengths and Difficulties Questionnaire (SDQ) (time frame: Baseline, 3-month follow-up, and 12-month follow-up). 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 NCT06840431, which also lists 13 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 4 Mar 2026.