Substance AbuseNCT03142009
Family Listening Program: Multi-Tribal Implementation and Evaluation
A study testing Intergenerational culturally adapted curriculum in people with Substance Abuse, run by University of New Mexico at 3 sites in United States.
Trial summary
This is a five-year R01 effectiveness trial where tribal partners are committed to assessing the Family Listening/Circle Program's effectiveness and disseminating the approach and intervention within Indian Country as a best practice in reducing substance abuse health disparities.Three specific aims of the grant are… Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Intergenerational culturally adapted curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2014to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: Inclusion criteria includes any families from Mescalero Apache, Jemez Pueblo and Ramah Navajo with a fourth and fifth-grade child and their parents or guardian, and grandparents who will volunteer to participate. Only children's data are analyzed.
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Exclusion Criteria:Those whom are ineligible in this study are: those that do not give consent and/or assent to participate; those that do not identify as tribal members of Mescalero Apache, Jemez Pueblo and Ramah Navajo or as the family member of someone that identifies as Mescalero Apache, Jemez Pueblo and Ramah Navajo; children and that are not in the targeted range of fourth and fifth grade.
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Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pueblo of Jemez Department of Education
Jemez Pueblo, New Mexico, 87024
Mescalero Prevention Program
Mescalero, New Mexico, 88340
Ramah Navajo School Board
Pinehill, New Mexico, 87357
About this study
This is a five-year R01 effectiveness trial where tribal partners are committed to assessing the Family Listening/Circle Program's effectiveness and disseminating the approach and intervention within Indian Country as a best practice in reducing substance abuse health disparities.Three specific aims of the grant are 1) To rigorously test effectiveness of FLCP; with a comparative longitudinal design within and across the tribes, with 4th graders to prevent substance initiation/use and strengthen families; 2) Through CBPR, support TRTs to transform their research capacities into local prevention research infrastructures and partnering; 3)To assess additional program effects on other health/education programs and leadership within the tribes. In sum, this multi-tribal/academic partnership builds on accomplishments to test the effectiveness of an innovative intervention. This grant provides an unparalleled opportunity to reduce substance abuse in three tribal communities, strengthen tribal research capacities, and impact substance abuse prevention research designs nationally, by illustrating how CBPR processes can integrate evidence-based and cultural-centered practices to create effective programs that generate community ownership and sustainability.
Read the detailed description
With substance abuse concerns plaguing tribal communities, health preventive approaches for American Indian (AI) children need urgent attention. Mainstream programs fall short by failing to speak to AI children on their own terms. Not so with the Family Listening/Circle Program (FL/CP) which integrates an evidence-based family-strengthening core, with cultural values and practices for 4th graders, their parents and elders. Through previous Native American Research Centers for Health funding (Indian Health Service \& National Institutes of Health partnership) the FL/CP was created and piloted by community-based participatory research (CBPR) partnerships between the University of New Mexico Center for Participatory Research and three tribal communities: Pueblo of Jemez, Ramah Band of Navajo and Mescalero Apache Nation. FL/CP fills a gap in substance abuse prevention by recapturing historic traditions of cultural transmission, such as family dinner story-telling where elders connect with children, supporting enhanced child-family communication and psycho-social coping through traditional dialogue, indigenous languages and empowerment where children and families create community action projects addressing community substance abuse. With initial FL/CP pilot and feasibility research completed, Tribal Research Teams (TRTs) from the Pueblo of Jemez, Ramah Band of Navajo and Mescalero Apache Nation are now in place for full program implementation and effectiveness testing through a longitudinal quasi-experimental design involving a long-term, multi-tribal/academic research partnership. Under this five-year R01 effectiveness trial, tribal partners are committed to assessing the program's effectiveness and disseminating the approach and intervention within Indian Country as a best practice in reducing substance abuse health disparities, with TRTs collaborating on all research activities, implementation, interpretation/analysis, and dissemination plans. Three specific aims are 1) To rigorously test effectiveness of FLCP; with a comparative longitudinal design within and across the tribes, with 4th graders to prevent substance initiation/use and strengthen families; 2) Through CBPR, support TRTs to transform their research capacities into local prevention research infrastructures and partnering; 3)To assess additional program effects on other health/education programs and leadership within the tribes. In sum, this multi-tribal/academic partnership builds on accomplishments to test the effectiveness of an innovative intervention. This grant provides an unparalleled opportunity to reduce substance abuse in three tribal communities, strengthen tribal research capacities, and impact substance abuse prevention research designs nationally, by illustrating how CBPR processes can integrate evidence-based and cultural-centered practices to create effective programs that generate community ownership and sustainability.
- Conditions
- Substance Abuse
- Being tested
- Intergenerational culturally adapted curriculum
- Keywords
- Community-Based Participatory Research
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intergenerational culturally adapted curriculumOther
Each session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their "home practice," which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week.
| Study group | Role | What they receive |
|---|---|---|
| Program group | Experimental | Tribal Research Team members recruit participants by sending letters home with the fourth and fifth grade children. This letter provides an overview of the FL/CP and invite interested parents and children to learn more. TRT and UNM team members follow-up with interested parents individually. If families are committed to being a part of FL/CP, a meeting is set to conduct the informed consent process and complete pretest. Families in the program group then attend FL/CP sessions which covers the intergenerational culturally adapted curriculum. Program families also participate in various aspects of the program including completing a Community Action Project. Receives: Other: Intergenerational culturally adapted curriculum |
| Comparison group | No intervention | Upon receiving the letter families that selected not to participate or who decline to participate will be invited to take part in the research study as comparison participants. Comparison participants do not attend the FL/CP sessions and only complete the pre, post and 1 year post tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Well-being
Self-report measures of anxiety, Anxiety Panic/GAD Sub-Scale, average change from baseline (pre-program participation). Anxiety Items coded are coded 1-4. The scale was calculated as the arithmetic average of items, which results in a minimum value of 1 and a maximum value of 4. Lower scores are better. The Panic/GAD sub-scale was the average of three items with the same min/max as the full scale. Children surveyed at pre-test, post-test (2-4 months after intervention), and one-year post intervention.
Measured: post-test (2-4 months after intervention)
Secondary outcomes (1)
Child Well-being
Self-report measures of depression, change from baseline at one-year, Depression scale items were coded 1 to 3, and the arithmetic mean of 26 items was used to compute the scale. The scale has a minimum of 1.0 and a maximum of 3.0 with higher values be better, i.e. lower levels of depression.
Measured: Post-post survey: One year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Apr 2014
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (84)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators use a two arm non-equivalent control group design with pretest, immediate post- test, and 12 month follow-up assessment points. Among quasi-experimental designs that could be employed, this design carries several advantages over other designs in being able to infer causality. One advantage of this design is that it allows for a more meaningful analysis of the impact of the FL/CP intervention by a comparison of the intervention group with the usual and customary comparison group, an advantage not possible with single-group over time designs. Second, the design provides an analysis of diffusion effects (i.e. the potential influence of the intervention on the comparison group over time). Given the tight social networks and small number of interconnected families in the three participating communities, the investigators expect some degree of program diffusion in the comparison group families.
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenda Belone, PhD, Principal investigator, University of New MexicoNina Wallerstein, DrPH, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142009
- Sponsor's protocol ID
- 14-289
- Status last verified
- Jan 2025
- First submitted
- 3 May 2017
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10.
PubMed 20147663Beauvais F. An integrated model for prevention and treatment of drug abuse among American Indian youth. J Addict Dis. 1992;11(3):63-80. doi: 10.1300/J069v11n03_04.
PubMed 1627667Mail PD, Johnson S. Boozing, sniffing, and toking: an overview of the past, present, and future of substance use by American Indians. Am Indian Alsk Nativ Ment Health Res (1987). 1993;5(2):1-33. doi: 10.5820/aian.0502.1993.1.
PubMed 8130311Beauvais F. Preventing Drug Abuse among Native American Young People. 1980, Fort Collins, CO: Western Behavioral Studies.
Beauvais F. Preventing Drug Abuse among Native American Young People. 1996, Ft. Collins, CO: Western Behavioral Studies
Okwumabua JO, Duryea EJ. Age of onset, periods of risk, and patterns of progression in drug use among American Indian high school students. Int J Addict. 1987 Dec;22(12):1269-76. doi: 10.3109/10826088709027486.
PubMed 3436694Swaim RC, Oetting ER, Edwards RW, Beauvais F. Links from emotional distress to adolescent drug use: a path model. J Consult Clin Psychol. 1989 Apr;57(2):227-31. doi: 10.1037//0022-006x.57.2.227.
PubMed 2708609NMDOH, Racial and ethnic health disparities report card, O.o.P.a.M. Health, Editor, 2007, NMDOH: Department of Health Santa Fe, NM. p. 1-24.
Szlemko WJ, Wood JW, Thurman PJ. Native Americans and alcohol: past, present, and future. J Gen Psychol. 2006 Oct;133(4):435-51. doi: 10.3200/GENP.133.4.435-451.
PubMed 17128961Miller WR. Motivational interviewing: research, practice, and puzzles. Addict Behav. 1996 Nov-Dec;21(6):835-42. doi: 10.1016/0306-4603(96)00044-5.
PubMed 8904947Borowsky IW, Resnick MD, Ireland M, Blum RW. Suicide attempts among American Indian and Alaska Native youth: risk and protective factors. Arch Pediatr Adolesc Med. 1999 Jun;153(6):573-80. doi: 10.1001/archpedi.153.6.573.
PubMed 10357296United States Census, B., 2010 Census Interactive Population Search: New Mexico, 2010.
Racial and Ethnic Health Disparities Report Card, 7th Edition, N.M.D.o. Health, Editor 2012, Office of Health Equity, Office of Policy and Accountability: Santa Fe, NM. p. 1-43.
New Mexico Youth Risk and Resiliency Survey (YRRS): American Indian High School Students - Aggregate Report, 2009, New Mexico Department of Health, New Mexico Public Education Department, University of New Mexico Prevention Research Center, Albuquerque Area Southwest Tribal Epidemiology Center. p. 1-197.
Oetting ER, Swaim RC, Edwards RW, Beauvais F. Indian and Anglo adolescent alcohol use and emotional distress: path models. Am J Drug Alcohol Abuse. 1989;15(2):153-72. doi: 10.3109/00952998909092718.
PubMed 2729224
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Listening Program: Multi-Tribal Implementation and Evaluation
- ClinicalTrials.gov ID
- NCT03142009
- Acronym / sponsor ID
- 14-289
- Conditions
- Substance Abuse
- Keywords
- Community-Based Participatory Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a five-year R01 effectiveness trial where tribal partners are committed to assessing the Family Listening/Circle Program's effectiveness and disseminating the approach and intervention within Indian Country as a best practice in reducing substance abuse health disparities.Three specific aims of the grant are 1) To rigorously test effectiveness of FLCP; with a comparative longitudinal design within and across the tribes, with 4th graders to prevent substance initiation/use and strengthen families; 2) Through CBPR, support TRTs to transform their research capacities into local prevention research infrastructures and partnering; 3)To assess additional program effects on other health/education programs and leadership within the tribes. In sum, this multi-tribal/academic partnership builds on accomplishments to test the effectiveness of an innovative intervention. This grant provides an unparalleled opportunity to reduce substance abuse in three tribal communities, strengthen tribal research capacities, and impact substance abuse prevention research designs nationally, by illustrating how CBPR processes can integrate evidence-based and cultural-centered practices to create effective programs that generate community ownership and sustainability.
Detailed description
With substance abuse concerns plaguing tribal communities, health preventive approaches for American Indian (AI) children need urgent attention. Mainstream programs fall short by failing to speak to AI children on their own terms. Not so with the Family Listening/Circle Program (FL/CP) which integrates an evidence-based family-strengthening core, with cultural values and practices for 4th graders, their parents and elders. Through previous Native American Research Centers for Health funding (Indian Health Service \& National Institutes of Health partnership) the FL/CP was created and piloted by community-based participatory research (CBPR) partnerships between the University of New Mexico Center for Participatory Research and three tribal communities: Pueblo of Jemez, Ramah Band of Navajo and Mescalero Apache Nation. FL/CP fills a gap in substance abuse prevention by recapturing historic traditions of cultural transmission, such as family dinner story-telling where elders connect with children, supporting enhanced child-family communication and psycho-social coping through traditional dialogue, indigenous languages and empowerment where children and families create community action projects addressing community substance abuse. With initial FL/CP pilot and feasibility research completed, Tribal Research Teams (TRTs) from the Pueblo of Jemez, Ramah Band of Navajo and Mescalero Apache Nation are now in place for full program implementation and effectiveness testing through a longitudinal quasi-experimental design involving a long-term, multi-tribal/academic research partnership. Under this five-year R01 effectiveness trial, tribal partners are committed to assessing the program's effectiveness and disseminating the approach and intervention within Indian Country as a best practice in reducing substance abuse health disparities, with TRTs collaborating on all research activities, implementation, interpretation/analysis, and dissemination plans. Three specific aims are 1) To rigorously test effectiveness of FLCP; with a comparative longitudinal design within and across the tribes, with 4th graders to prevent substance initiation/use and strengthen families; 2) Through CBPR, support TRTs to transform their research capacities into local prevention research infrastructures and partnering; 3)To assess additional program effects on other health/education programs and leadership within the tribes. In sum, this multi-tribal/academic partnership builds on accomplishments to test the effectiveness of an innovative intervention. This grant provides an unparalleled opportunity to reduce substance abuse in three tribal communities, strengthen tribal research capacities, and impact substance abuse prevention research designs nationally, by illustrating how CBPR processes can integrate evidence-based and cultural-centered practices to create effective programs that generate community ownership and sustainability.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators use a two arm non-equivalent control group design with pretest, immediate post- test, and 12 month follow-up assessment points. Among quasi-experimental designs that could be employed, this design carries several advantages over other designs in being able to infer causality. One advantage of this design is that it allows for a more meaningful analysis of the impact of the FL/CP intervention by a comparison of the intervention group with the usual and customary comparison group, an advantage not possible with single-group over time designs. Second, the design provides an analysis of diffusion effects (i.e. the potential influence of the intervention on the comparison group over time). Given the tight social networks and small number of interconnected families in the three participating communities, the investigators expect some degree of program diffusion in the comparison group families.
| Arm | Type | Receives |
|---|---|---|
| Program group | Experimental | Other: Intergenerational culturally adapted curriculumTribal Research Team members recruit participants by sending letters home with the fourth and fifth grade children. This letter provides an overview of the FL/CP and invite interested parents and children to learn more. TRT and UNM team members follow-up with interested parents individually. If families are committed to being a part of FL/CP, a meeting is set to conduct the informed consent process and complete pretest. Families in the program group then attend FL/CP sessions which covers the intergenerational culturally adapted curriculum. Program families also participate in various aspects of the program including completing a Community Action Project. |
| Comparison group | No intervention | –Upon receiving the letter families that selected not to participate or who decline to participate will be invited to take part in the research study as comparison participants. Comparison participants do not attend the FL/CP sessions and only complete the pre, post and 1 year post tests. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Intergenerational culturally adapted curriculumEach session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their "home practice," which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week. | Other | Program group |
Primary outcome
Child Well-being
Time frame: post-test (2-4 months after intervention)
Self-report measures of anxiety, Anxiety Panic/GAD Sub-Scale, average change from baseline (pre-program participation). Anxiety Items coded are coded 1-4. The scale was calculated as the arithmetic average of items, which results in a minimum value of 1 and a maximum value of 4. Lower scores are better. The Panic/GAD sub-scale was the average of three items with the same min/max as the full scale. Children surveyed at pre-test, post-test (2-4 months after intervention), and one-year post intervention.
1 secondary outcome
Child Well-being
Time frame: Post-post survey: One year after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20147663Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10.
- Background: PubMed 1627667Beauvais F. An integrated model for prevention and treatment of drug abuse among American Indian youth. J Addict Dis. 1992;11(3):63-80. doi: 10.1300/J069v11n03_04.
- Background: PubMed 8130311Mail PD, Johnson S. Boozing, sniffing, and toking: an overview of the past, present, and future of substance use by American Indians. Am Indian Alsk Nativ Ment Health Res (1987). 1993;5(2):1-33. doi: 10.5820/aian.0502.1993.1.
- BackgroundBeauvais F. Preventing Drug Abuse among Native American Young People. 1980, Fort Collins, CO: Western Behavioral Studies.
- BackgroundBeauvais F. Preventing Drug Abuse among Native American Young People. 1996, Ft. Collins, CO: Western Behavioral Studies
- Background: PubMed 3436694Okwumabua JO, Duryea EJ. Age of onset, periods of risk, and patterns of progression in drug use among American Indian high school students. Int J Addict. 1987 Dec;22(12):1269-76. doi: 10.3109/10826088709027486.
- Background: PubMed 2708609Swaim RC, Oetting ER, Edwards RW, Beauvais F. Links from emotional distress to adolescent drug use: a path model. J Consult Clin Psychol. 1989 Apr;57(2):227-31. doi: 10.1037//0022-006x.57.2.227.
- BackgroundNMDOH, Racial and ethnic health disparities report card, O.o.P.a.M. Health, Editor, 2007, NMDOH: Department of Health Santa Fe, NM. p. 1-24.
- Background: PubMed 17128961Szlemko WJ, Wood JW, Thurman PJ. Native Americans and alcohol: past, present, and future. J Gen Psychol. 2006 Oct;133(4):435-51. doi: 10.3200/GENP.133.4.435-451.
- Background: PubMed 8904947Miller WR. Motivational interviewing: research, practice, and puzzles. Addict Behav. 1996 Nov-Dec;21(6):835-42. doi: 10.1016/0306-4603(96)00044-5.
- Background: PubMed 10357296Borowsky IW, Resnick MD, Ireland M, Blum RW. Suicide attempts among American Indian and Alaska Native youth: risk and protective factors. Arch Pediatr Adolesc Med. 1999 Jun;153(6):573-80. doi: 10.1001/archpedi.153.6.573.
- BackgroundUnited States Census, B., 2010 Census Interactive Population Search: New Mexico, 2010.
- Individual participant dataSharing planned: No
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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.
Lorenda Belone, PhD principal investigator
University of New Mexico
Nina Wallerstein, DrPH principal investigator
University of New Mexico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intergenerational culturally adapted curriculum in people with Substance Abuse, run by University of New Mexico at 3 sites 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?
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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Child Well-being (time frame: post-test (2-4 months after intervention)). 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 NCT03142009, which also lists 84 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 3 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.