Health EquityNCT06896942
Autism Doula Program Evaluation
A study testing Autism Doula and DDBP Family Navigation in people with Health Equity and Autism Spectrum Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Background: Findings from a group level assessment with caregivers of Black children with autism revealed barriers to equitable care and services (e.g., a lack of cultural representation among their child's care team, caregiver stress, stigma, and uncertainty about services needed). Read more about this study
- Who is it for?
- Ages 18 to 71 months
- Conditions the study is for
- Health Equity, Autism Spectrum Disorder
- What is being tested?
- Autism Doula and DDBP Family Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2025to 31 Aug 2025
- 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 to 71 months
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: caregivers of children who are 18 months to five years and recently diagnosed with autism. Caregivers must identify as Black and be over the age of 18 and identify their children as Black.
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, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45209
Teresa Smith, PhD, 614-313-7432, teresa.smith@cchmc.org
About this study
Official title: EVALUATION OF A COMMUNITY DRIVEN, EQUITABLE INTERVENTION FOR BLACK CHILDREN WITH AUTISM
Background: Findings from a group level assessment with caregivers of Black children with autism revealed barriers to equitable care and services (e.g., a lack of cultural representation among their child's care team, caregiver stress, stigma, and uncertainty about services needed). The Autism Doula program was identified by the community to address the aforementioned barriers and provide culturally matched family navigation and social-emotional support while also acknowledging the unique experiences and values of caregivers of Black children with autism.
Impact: The current project aims to assess the acceptability, feasibility, and preliminary effectiveness of the Autism Doula program and promote equitable care for Black children with autism and their families.
Read more
Methods: Fifty-six Black families of children 18 months to five years of age who recently received a new diagnosis of autism spectrum disorder from CCHMC will be recruited to the current study. Twenty-six families will be randomly assigned to either the control group (i.e., care as usual including DDBP Family Navigation) or the intervention group (i.e., Autism Doula services). Feasibility and acceptability data will be gathered, including satisfaction of both groups, how many families approached agree to be in the study, how many sessions with the doula were successfully completed, and was the intervention content delivered as intended. Additionally, preliminary effectiveness will be evaluated by examining completion of recommended next steps, caregivers' perceived stress, and self-efficacy.
Implications: Data from this project will provide evidence that the Autism Doula program is feasible, acceptable, and effective, ultimately demonstrating it as an equitable care approach for Black children with autism and their families.
Future Directions: Findings from this pilot project will highlight the need for growth of the Autism Doula program to promote culturally competent care and health equity for Black children with autism and their families.
Read the detailed description
The current project aims to evaluate a community driven, equitable intervention for Black children with autism. Specifically, we will assess the feasibility and acceptability of the Autism Doula program to enhance culturally responsive care and services for Black children newly diagnosed with autism and their families. The Autism Doula intervention will be measured in several ways, including number of families who complete the Autism Doula intervention, Autism Doula sessions successfully completed, content delivered as intended, and the satisfaction of the families involved in the intervention group. Additionally, preliminary effectiveness will be assessed by comparing the intervention group (i.e., families who receive Autism Doula services) to the experiences of families who receive care as usual including DDBP Family Navigation. Specifically, we will examine caregiver perceived stress levels, caregiver self-efficacy, and initiation of recommended next steps/services. We hypothesize that families receiving Autism Doula services will report high satisfaction with the program and that the program will be determined to be feasible and effective. Should results reveal acceptability, feasibility, and preliminary effectiveness of the Autism Doula intervention, additional funding will be sought out in collaboration with the Division of Developmental and Behavioral Pediatrics (DDBP) at CCHMC to expand the program. Aligned with the hospital wide initiative of incorporating family navigation into clinical care, DDBP leadership has made it a priority to provide culturally-response family navigation, similar to the Autism Doula program.
- Conditions
- Health Equity, Autism Spectrum Disorder
- Being tested
- Autism Doula, DDBP Family Navigation
- Keywords
- health equity, autism spectrum disorder, family navigation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism DoulaOther
The Autism Doula provides caregiver support, navigation with next steps for their child, connects families to resources and the Black autism community, and coordinates services to help alleviate caregiver stress (e.g., cleaning, cooking, respite care).
DDBP Family NavigationOther
A one-time consult with a DDBP family navigator via telehealth to come up with an action plan for next steps for the patient's care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Autism doula care includes providing caregivers with culturally-responsive support, helping them navigating next steps for their child's care, connecting them with the Black autism community, and providing services to alleviate caregiver stress (e.g., cooking, cleaning, respite care). Receives: Other: Autism Doula |
| Control group | Active comparator | The control group will receive care as usual and a referral to DDBP family navigation, which is usually a one time telehealth appointment to plan next steps for their child's care. Receives: Other: DDBP Family Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Doula field notes
The Autism Doula will have an electronic field note in REDCap that includes the date of contact with family, contact method, and a checklist of intervention content delivered (e.g., assistance with scheduling therapy, contacting early intervention, providing social support). To ensure confidentiality of participants, this REDCap project will be separate from the REDCap project for study measures.
Measured: from enrollment to end of doula program at 3 months
Satisfaction Survey
This survey will be given following completion of the Autism Doula program or at three months for the control group. This survey will have two versions, one for the Autism Doula program and one for DDBP Family Navigation, and was adapted from the Patient Satisfaction with Logistical Aspects of Navigation Scale (PSN-L). Questions will be asked on a Likert Scale from 1 (strongly disagree) to 5 (strongly agree) and include their satisfaction with the services they received from the Autism Doula. The items are summed for a total score and higher scores indicate higher satisfaction. There will also be a comment section for open-ended feedback.
Measured: end of the autism doula program at 3 months after enrollment
Chart Review Form:
The Chart Review form was developed by research staff and will be used to obtain relevant information pertaining to the completion of recommended next steps, including the following: speech therapy, occupational therapy, Applied Behavior Analysis, Early Intervention services, establishing care with a developmental pediatrician, and behavior therapy. This form will be completed by research staff three months after study enrolment for the control group and after completion of the Autism Doula program for the intervention group (i.e., three months).
Measured: end of the autism doula program at 3 months after enrollment
Secondary outcomes (2)
Perceived Stress Scale (PSS)
The PSS measures perceptions of stress according to how uncontrollable, unpredictable, and overloaded participants view their lives. This 14 item self-report test measures stress from ongoing life circumstances, from anticipating future events, and reactions to specific events. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. The manual for the PSS reports findings supporting the reliability and validity of this measure. This survey will be administered at study enrollment and again three months later for the control group and after completion of the Autism Doula program for the intervention group (i.e., three months).
Measured: at study enrollment until after autism doula intervention (3 months)
Early Intervention (EI) Parent Self Efficacy Scale
This scale is a 16-item scale used to assess EI related competence beliefs of parents of children with disabilities. The manual for this scale reports findings supporting the reliability and validity of this measure. This survey will be administered at study enrollment and again six months later for the control group and after completion of the Autism Doula program for the intervention group.
Measured: at study enrollment until after autism doula intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start18 Jan 2025
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Health EquityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This pilot study will obtain and compare data from the intervention group (i.e., families receiving Autism Doula services) and the control group (i.e., families receiving care as usual including DDBP Family Navigation) to examine the acceptability, feasibility, and preliminary effectiveness of an Autism Doula program.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896942
- Sponsor's protocol ID
- 2024-0473
- Other IDs
- UL1TR001425
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Publications
Hoagwood KE, Cavaleri MA, Serene Olin S, Burns BJ, Slaton E, Gruttadaro D, Hughes R. Family support in children's mental health: a review and synthesis. Clin Child Fam Psychol Rev. 2010 Mar;13(1):1-45. doi: 10.1007/s10567-009-0060-5.
PubMed 20012893Ogunwole SM, Bennett WL, Williams AN, Bower KM. Community-Based Doulas and COVID-19: Addressing Structural and Institutional Barriers to Maternal Health Equity. Perspect Sex Reprod Health. 2020 Dec;52(4):199-204. doi: 10.1363/psrh.12169. Epub 2021 Jan 5. No abstract available.
PubMed 33399272Castelin S, Okorodudu J, Smith T. Partnering With a Purpose: Promoting Equity and Justice for Black Children With Autism Spectrum Disorder. J Dev Behav Pediatr. 2024 Jul-Aug 01;45(4):e302-e308. doi: 10.1097/DBP.0000000000001276. Epub 2024 Jul 17.
PubMed 39023854Smith KA, Gehricke JG, Iadarola S, Wolfe A, Kuhlthau KA. Disparities in Service Use Among Children With Autism: A Systematic Review. Pediatrics. 2020 Apr;145(Suppl 1):S35-S46. doi: 10.1542/peds.2019-1895G.
PubMed 32238530Shaw KA, Bilder DA, McArthur D, Williams AR, Amoakohene E, Bakian AV, Durkin MS, Fitzgerald RT, Furnier SM, Hughes MM, Pas ET, Salinas A, Warren Z, Williams S, Esler A, Grzybowski A, Ladd-Acosta CM, Patrick M, Zahorodny W, Green KK, Hall-Lande J, Lopez M, Mancilla KC, Nguyen RHN, Pierce K, Schwenk YD, Shenouda J, Sidwell K, Vehorn A, DiRienzo M, Gutierrez J, Hallas L, Hudson A, Spivey MH, Pettygrove S, Washington A, Maenner MJ. Early Identification of Autism Spectrum Disorder Among Children Aged 4 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2020. MMWR Surveill Summ. 2023 Mar 24;72(1):1-15. doi: 10.15585/mmwr.ss7201a1.
PubMed 36952289Fisher AP, Lynch JD, Jacquez FM, Mitchell MJ, Kamimura-Nishimura KI, Wade SL. A systematic review examining caregivers' of color experiences with the diagnostic process of autism spectrum disorder. Autism. 2023 May;27(4):876-889. doi: 10.1177/13623613221128171. Epub 2022 Nov 2.
PubMed 36321366Magana S, Parish SL, Son E. Have Racial and Ethnic Disparities in the Quality of Health Care Relationships Changed for Children With Developmental Disabilities and ASD? Am J Intellect Dev Disabil. 2015 Nov;120(6):504-13. doi: 10.1352/1944-7558-120.6.504.
PubMed 26505871
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF A COMMUNITY DRIVEN, EQUITABLE INTERVENTION FOR BLACK CHILDREN WITH AUTISM
- ClinicalTrials.gov ID
- NCT06896942
- Acronym / sponsor ID
- 2024-0473
- Conditions
- Health Equity, Autism Spectrum Disorder
- Keywords
- health equity, autism spectrum disorder, family navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 26 Mar 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.
Background: Findings from a group level assessment with caregivers of Black children with autism revealed barriers to equitable care and services (e.g., a lack of cultural representation among their child's care team, caregiver stress, stigma, and uncertainty about services needed). The Autism Doula program was identified by the community to address the aforementioned barriers and provide culturally matched family navigation and social-emotional support while also acknowledging the unique experiences and values of caregivers of Black children with autism.
Impact: The current project aims to assess the acceptability, feasibility, and preliminary effectiveness of the Autism Doula program and promote equitable care for Black children with autism and their families.
Methods: Fifty-six Black families of children 18 months to five years of age who recently received a new diagnosis of autism spectrum disorder from CCHMC will be recruited to the current study. Twenty-six families will be randomly assigned to either the control group (i.e., care as usual including DDBP Family Navigation) or the intervention group (i.e., Autism Doula services). Feasibility and acceptability data will be gathered, including satisfaction of both groups, how many families approached agree to be in the study, how many sessions with the doula were successfully completed, and was the intervention content delivered as intended. Additionally, preliminary effectiveness will be evaluated by examining completion of recommended next steps, caregivers' perceived stress, and self-efficacy.
Implications: Data from this project will provide evidence that the Autism Doula program is feasible, acceptable, and effective, ultimately demonstrating it as an equitable care approach for Black children with autism and their families.
Future Directions: Findings from this pilot project will highlight the need for growth of the Autism Doula program to promote culturally competent care and health equity for Black children with autism and their families.
Detailed description
The current project aims to evaluate a community driven, equitable intervention for Black children with autism. Specifically, we will assess the feasibility and acceptability of the Autism Doula program to enhance culturally responsive care and services for Black children newly diagnosed with autism and their families. The Autism Doula intervention will be measured in several ways, including number of families who complete the Autism Doula intervention, Autism Doula sessions successfully completed, content delivered as intended, and the satisfaction of the families involved in the intervention group. Additionally, preliminary effectiveness will be assessed by comparing the intervention group (i.e., families who receive Autism Doula services) to the experiences of families who receive care as usual including DDBP Family Navigation. Specifically, we will examine caregiver perceived stress levels, caregiver self-efficacy, and initiation of recommended next steps/services. We hypothesize that families receiving Autism Doula services will report high satisfaction with the program and that the program will be determined to be feasible and effective. Should results reveal acceptability, feasibility, and preliminary effectiveness of the Autism Doula intervention, additional funding will be sought out in collaboration with the Division of Developmental and Behavioral Pediatrics (DDBP) at CCHMC to expand the program. Aligned with the hospital wide initiative of incorporating family navigation into clinical care, DDBP leadership has made it a priority to provide culturally-response family navigation, similar to the Autism Doula program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This pilot study will obtain and compare data from the intervention group (i.e., families receiving Autism Doula services) and the control group (i.e., families receiving care as usual including DDBP Family Navigation) to examine the acceptability, feasibility, and preliminary effectiveness of an Autism Doula program.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Autism DoulaAutism doula care includes providing caregivers with culturally-responsive support, helping them navigating next steps for their child's care, connecting them with the Black autism community, and providing services to alleviate caregiver stress (e.g., cooking, cleaning, respite care). |
| Control group | Active comparator | Other: DDBP Family NavigationThe control group will receive care as usual and a referral to DDBP family navigation, which is usually a one time telehealth appointment to plan next steps for their child's care. |
Who may qualify
- Ages
- 18 to 71 months
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Autism DoulaThe Autism Doula provides caregiver support, navigation with next steps for their child, connects families to resources and the Black autism community, and coordinates services to help alleviate caregiver stress (e.g., cleaning, cooking, respite care). | Other | Intervention Group |
| DDBP Family NavigationA one-time consult with a DDBP family navigator via telehealth to come up with an action plan for next steps for the patient's care. | Other | Control group |
Primary outcome
Autism Doula field notes
Time frame: from enrollment to end of doula program at 3 months
The Autism Doula will have an electronic field note in REDCap that includes the date of contact with family, contact method, and a checklist of intervention content delivered (e.g., assistance with scheduling therapy, contacting early intervention, providing social support). To ensure confidentiality of participants, this REDCap project will be separate from the REDCap project for study measures.
Satisfaction Survey
Time frame: end of the autism doula program at 3 months after enrollment
This survey will be given following completion of the Autism Doula program or at three months for the control group. This survey will have two versions, one for the Autism Doula program and one for DDBP Family Navigation, and was adapted from the Patient Satisfaction with Logistical Aspects of Navigation Scale (PSN-L). Questions will be asked on a Likert Scale from 1 (strongly disagree) to 5 (strongly agree) and include their satisfaction with the services they received from the Autism Doula. The items are summed for a total score and higher scores indicate higher satisfaction. There will also be a comment section for open-ended feedback.
Chart Review Form:
Time frame: end of the autism doula program at 3 months after enrollment
The Chart Review form was developed by research staff and will be used to obtain relevant information pertaining to the completion of recommended next steps, including the following: speech therapy, occupational therapy, Applied Behavior Analysis, Early Intervention services, establishing care with a developmental pediatrician, and behavior therapy. This form will be completed by research staff three months after study enrolment for the control group and after completion of the Autism Doula program for the intervention group (i.e., three months).
2 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: at study enrollment until after autism doula intervention (3 months)
Early Intervention (EI) Parent Self Efficacy Scale
Time frame: at study enrollment until after autism doula intervention (3 months)
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 26 Mar 2025.
- Background: PubMed 20012893Hoagwood KE, Cavaleri MA, Serene Olin S, Burns BJ, Slaton E, Gruttadaro D, Hughes R. Family support in children's mental health: a review and synthesis. Clin Child Fam Psychol Rev. 2010 Mar;13(1):1-45. doi: 10.1007/s10567-009-0060-5.
- Background: PubMed 33399272Ogunwole SM, Bennett WL, Williams AN, Bower KM. Community-Based Doulas and COVID-19: Addressing Structural and Institutional Barriers to Maternal Health Equity. Perspect Sex Reprod Health. 2020 Dec;52(4):199-204. doi: 10.1363/psrh.12169. Epub 2021 Jan 5. No abstract available.
- Background: PubMed 39023854Castelin S, Okorodudu J, Smith T. Partnering With a Purpose: Promoting Equity and Justice for Black Children With Autism Spectrum Disorder. J Dev Behav Pediatr. 2024 Jul-Aug 01;45(4):e302-e308. doi: 10.1097/DBP.0000000000001276. Epub 2024 Jul 17.
- Background: PubMed 32238530Smith KA, Gehricke JG, Iadarola S, Wolfe A, Kuhlthau KA. Disparities in Service Use Among Children With Autism: A Systematic Review. Pediatrics. 2020 Apr;145(Suppl 1):S35-S46. doi: 10.1542/peds.2019-1895G.
- Background: PubMed 36952289Shaw KA, Bilder DA, McArthur D, Williams AR, Amoakohene E, Bakian AV, Durkin MS, Fitzgerald RT, Furnier SM, Hughes MM, Pas ET, Salinas A, Warren Z, Williams S, Esler A, Grzybowski A, Ladd-Acosta CM, Patrick M, Zahorodny W, Green KK, Hall-Lande J, Lopez M, Mancilla KC, Nguyen RHN, Pierce K, Schwenk YD, Shenouda J, Sidwell K, Vehorn A, DiRienzo M, Gutierrez J, Hallas L, Hudson A, Spivey MH, Pettygrove S, Washington A, Maenner MJ. Early Identification of Autism Spectrum Disorder Among Children Aged 4 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2020. MMWR Surveill Summ. 2023 Mar 24;72(1):1-15. doi: 10.15585/mmwr.ss7201a1.
- Background: PubMed 36321366Fisher AP, Lynch JD, Jacquez FM, Mitchell MJ, Kamimura-Nishimura KI, Wade SL. A systematic review examining caregivers' of color experiences with the diagnostic process of autism spectrum disorder. Autism. 2023 May;27(4):876-889. doi: 10.1177/13623613221128171. Epub 2022 Nov 2.
- Background: PubMed 26505871Magana S, Parish SL, Son E. Have Racial and Ethnic Disparities in the Quality of Health Care Relationships Changed for Children With Developmental Disabilities and ASD? Am J Intellect Dev Disabil. 2015 Nov;120(6):504-13. doi: 10.1352/1944-7558-120.6.504.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autism Doula and DDBP Family Navigation in people with Health Equity and Autism Spectrum Disorder, run by Children's Hospital Medical Center, Cincinnati 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?
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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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?
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?
Contact Teresa Smith, PhD (6143137432, teresa.smith@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Doula field notes (time frame: from enrollment to end of doula program at 3 months). 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?
On the ClinicalTrials.gov record for NCT06896942, which also lists 7 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 26 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.