Program, CommunicationNCT06564025
Pilot of an Online Sexual Health Program
A study testing Pilot program study in people with Program, Communication, run by Wellesley College at 1 site in United States.
Trial summary
This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Program, Communication
- What is being tested?
- Pilot program study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 1 Mar 2026
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- adult (18 or older)
- father (biological, step, adopted, or foster) of a participating teen and
- report regular contact with the teen
- healthy enough to participate in online surveys, an online intervention, interactive activities (either online, over the phone or in-person) with the adolescent, and an online support group
- speak English
- have a reading level of 6th grade or above.
Who cannot join
- not a father (biological, step, adopted, or foster) of a participating high-school aged teen
- under the age of 18
- not in regular contact with their teen
- cannot participate in intervention in English Inclusion criteria for adolescents
- high-school aged child (biological, step, adopted, or foster) of a participating father
- report regular contact with their father
Show all 12Show fewer
- healthy enough to participate in online surveys and interactive activities (either online, over the phone or in-person) with the father
- have a reading level of 6th grade or above Exclusion criteria for adolescents
- not in high school
- not in regular contact with the father
- not child (biological, step, adopted, or foster) of participating father
- cannot participate in intervention in English
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
Wellesley College
Wellesley, Massachusetts, 02481
Jennifer M Grossman, Ph.D., 781-283-2521, jgrossma@wellesley.edu
Michelle Sullivan, Ph.D., 781-283-3277, ms154@wellesley.edu
About this study
Official title: Pilot of a Father-based Intervention to Support Adolescents' Reproductive Health
This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.
Read the detailed description
This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data from Acceptability of Intervention Measure and Feasibility of Intervention Measure, and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.
The investigators will recruit a diverse sample of father-adolescent pairs (N=50 pairs) through partnership with three community partner organizations. Fathers will be asked questions online to determine project eligibility and demographics (screener) and given an online consent form. If a father agrees to teens' participation, the teen will be sent an assent form for their own participation and a brief screener survey. If teens are 18 or older, the investigators will request their contact information from participating fathers and ask teens to provide their own consent. Only father/teen pairs who complete the screeners and consent/assent forms, meet eligibility criteria, and both agree to participate can join the study.
All pilot participants will be given a pre-and post-intervention survey to assess any change in proximal outcomes. Participants will be asked to participate in 3 online modules over 6 weeks which include 3 online lessons (father and teens complete separately) and father/teen activities (fathers and teens complete together) and 3 father support group (father only). Each module will last one week and will include an online lesson and father-teen activity (fathers and teens) and online father support group session (fathers only). Lessons and support group sessions will include feedback questions (acceptability). Tracking of enrollment, retention, and duration of lesson participation will provide feasibility assessment. To obtain in-depth feedback on participants' responses to the intervention (acceptability), and to conduct member checks on pilot lesson feedback, the investigators will conduct debrief interviews with a purposive sample of pilot participants (5 fathers, 5 teens) with variation in: teen gender and level of intervention engagement.
The 3 module, 3-week intervention will be delivered on Qualtrics and Zoom, accessible via computer or tablet. Online lessons will be self-paced within each week and will each include a father-teen activity, with text and e-mail reminders at the start and end of the week. Father support groups will occur online at a scheduled time planned based on fathers' schedules. Given the limited scope of the project, prototype technology will be relatively simple, with more advanced technology planned for a future R01.
- Conditions
- Program, Communication
- Being tested
- Pilot program study
- Keywords
- sex education, father-teen program, family intervention
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot program studyBehavioural
To assess program feasibility, acceptability, and preliminary efficacy, we will pilot the intervention with a purposive sample of 50 father-teen pairs (100 participants total). All participants will receive the program.
| Study group | Role | What they receive |
|---|---|---|
| Pilot group for program | Experimental | To assess program feasibility, acceptability, and preliminary efficacy, we will pilot the intervention with a purposive sample of 50 father-teen pairs (100 participants total). All participants will receive the program. Receives: Behavioral: Pilot program study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual knowledge
Participants' knowledge about contraception, condom use, and sexually transmitted infections for fathers and teens (3 sub-scales, self-report, true/false with higher score indicating greater knowledge).
Measured: immediately before and immediately after the intervention
Sexual Communication Self-Efficacy Scale
Teen participants' confidence in their capacity to talk with a partner about sexual issues including using protection during sex (5 subscales, self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy).
Measured: immediately before and immediately after the intervention
Self-Efficacy in Relationships
Teen participants' confidence in their capacity to talk with a partner what they want and do not want in a relationship such as breaking up with someone they no longer like (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy).
Measured: immediately before and immediately after the intervention
Self-Efficacy for Consent
Teen participants' confidence in their capacity to talk with a partner about consent, including asking for consent for sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy).
Measured: immediately before and immediately after the intervention
Self-Efficacy for Communication with Teens about Sex
Father participants' confidence in their capacity to talk with their teen about sexual issues and relationships (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy).
Measured: immediately before and immediately after the intervention
Comfort Talking with Family about Sex
Participants' comfort to talk with their father/teen about sexual issues and relationships for fathers and teens including being able to talk openly and honestly about sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher comfort).
Measured: immediately before and immediately after the intervention
Open Communication Scale
Participants' comfort to talk with their father/teen about sex and relationships for fathers and teens including comfort talking through questions about sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher comfort).
Measured: immediately before and immediately after the intervention
Communication about Sex and Protection
Participants' reported frequency of talk with their father/teen about sex and relationships including talking with your father/teen about how to use condoms (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication).
Measured: immediately before and immediately after the intervention
Communication with family about sex & relationships
Participants' reported frequency of talk with their father/teen about sex and relationships including talk about value about sex and relationships (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication).
Measured: immediately before and immediately after the intervention
Frequency of Talk with Family about Sex and Relationships
Participants' reported frequency of talk with their father/teen about sex and relationships including when it is ok to have sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication).
Measured: immediately before and immediately after the intervention
Feasibility of Intervention Measure
Participants' experience of the program's accessibility including whether the program seems doable for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher feasibility).
Measured: immediately after the intervention
Feasibility: Participants' experience of the program's ease
Participants' experience of the program's ease of use including whether the program was well-organized for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher feasibility).
Measured: immediately after the intervention
Acceptability of Intervention Measure: whether participants approve of the program
Participants' experience of the program including whether they approve of the program for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher acceptability).
Measured: immediately after the intervention
Intervention Acceptability and Tolerability: Participants' experience of the program's importance
Participants' experience of the program's importance including whether they think the program was helpful for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher acceptability).
Measured: immediately 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 posted21 Aug 2024
- Study start30 Jan 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Program, CommunicationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- To assess program feasibility, acceptability, and preliminary efficacy, the investigators will pilot the intervention with a purposive sample of 50 father-teen pairs. All participants will receive the intervention. An online screener, pre- and post-intervention surveys, and brief module feedback will assess feasibility and acceptability. Pre- and post-intervention surveys will provide initial data on directionality for correlates of teens' sexual risk behaviors to determine whether a full-scale R01 is warranted. Debrief interviews with a purposive sample of pilot participants (5 fathers, 5 teens) will obtain in-depth intervention feedback and conduct member checks on module feedback. The investigators will revise the intervention prototype based on feasibility, acceptability, and preliminary efficacy data, then write up and distribute findings for dissemination.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellesley College
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jennifer Grossman, Wellesley College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564025
- Sponsor's protocol ID
- 23139
- Other IDs
- 1R21HD109744-01A1
- Status last verified
- Apr 2025
- First submitted
- 2 Aug 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Documentation to be made publicly available to the research community will include pilot surveys and interview protocols, along with a detailed User Guide for interviews. A survey codebook will include a description of all items and survey measures as well as variable names, variable labels, and standard codes for missing values. Interview data will include a description of recoded data categories. We expect study data and associated documentation will be made available to the research community free of charge through the Inter-university Consortium for Political and Social Research (ICPSR).
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of a Father-based Intervention to Support Adolescents' Reproductive Health
- ClinicalTrials.gov ID
- NCT06564025
- Acronym / sponsor ID
- 23139
- Conditions
- Program, Communication
- Keywords
- sex education, father-teen program, family intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wellesley CollegeUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Aug 2024 (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.
This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.
Detailed description
This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data from Acceptability of Intervention Measure and Feasibility of Intervention Measure, and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.
The investigators will recruit a diverse sample of father-adolescent pairs (N=50 pairs) through partnership with three community partner organizations. Fathers will be asked questions online to determine project eligibility and demographics (screener) and given an online consent form. If a father agrees to teens' participation, the teen will be sent an assent form for their own participation and a brief screener survey. If teens are 18 or older, the investigators will request their contact information from participating fathers and ask teens to provide their own consent. Only father/teen pairs who complete the screeners and consent/assent forms, meet eligibility criteria, and both agree to participate can join the study.
All pilot participants will be given a pre-and post-intervention survey to assess any change in proximal outcomes. Participants will be asked to participate in 3 online modules over 6 weeks which include 3 online lessons (father and teens complete separately) and father/teen activities (fathers and teens complete together) and 3 father support group (father only). Each module will last one week and will include an online lesson and father-teen activity (fathers and teens) and online father support group session (fathers only). Lessons and support group sessions will include feedback questions (acceptability). Tracking of enrollment, retention, and duration of lesson participation will provide feasibility assessment. To obtain in-depth feedback on participants' responses to the intervention (acceptability), and to conduct member checks on pilot lesson feedback, the investigators will conduct debrief interviews with a purposive sample of pilot participants (5 fathers, 5 teens) with variation in: teen gender and level of intervention engagement.
The 3 module, 3-week intervention will be delivered on Qualtrics and Zoom, accessible via computer or tablet. Online lessons will be self-paced within each week and will each include a father-teen activity, with text and e-mail reminders at the start and end of the week. Father support groups will occur online at a scheduled time planned based on fathers' schedules. Given the limited scope of the project, prototype technology will be relatively simple, with more advanced technology planned for a future R01.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To assess program feasibility, acceptability, and preliminary efficacy, the investigators will pilot the intervention with a purposive sample of 50 father-teen pairs. All participants will receive the intervention. An online screener, pre- and post-intervention surveys, and brief module feedback will assess feasibility and acceptability. Pre- and post-intervention surveys will provide initial data on directionality for correlates of teens' sexual risk behaviors to determine whether a full-scale R01 is warranted. Debrief interviews with a purposive sample of pilot participants (5 fathers, 5 teens) will obtain in-depth intervention feedback and conduct member checks on module feedback. The investigators will revise the intervention prototype based on feasibility, acceptability, and preliminary efficacy data, then write up and distribute findings for dissemination.
| Arm | Type | Receives |
|---|---|---|
| Pilot group for program | Experimental | Behavioral: Pilot program studyTo assess program feasibility, acceptability, and preliminary efficacy, we will pilot the intervention with a purposive sample of 50 father-teen pairs (100 participants total). All participants will receive the program. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- adult (18 or older)
- father (biological, step, adopted, or foster) of a participating teen and
- report regular contact with the teen
- healthy enough to participate in online surveys, an online intervention, interactive activities (either online, over the phone or in-person) with the adolescent, and an online support group
- speak English
Key exclusion criteria (12 listed)
- not a father (biological, step, adopted, or foster) of a participating high-school aged teen
- under the age of 18
- not in regular contact with their teen
- cannot participate in intervention in English Inclusion criteria for adolescents
- high-school aged child (biological, step, adopted, or foster) of a participating father
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 |
|---|---|---|
| Pilot program studyTo assess program feasibility, acceptability, and preliminary efficacy, we will pilot the intervention with a purposive sample of 50 father-teen pairs (100 participants total). All participants will receive the program. | Behavioural | Pilot group for program |
Primary outcome
Sexual knowledge
Time frame: immediately before and immediately after the intervention
Participants' knowledge about contraception, condom use, and sexually transmitted infections for fathers and teens (3 sub-scales, self-report, true/false with higher score indicating greater knowledge).
Sexual Communication Self-Efficacy Scale
Time frame: immediately before and immediately after the intervention
Teen participants' confidence in their capacity to talk with a partner about sexual issues including using protection during sex (5 subscales, self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy).
Self-Efficacy in Relationships
Time frame: immediately before and immediately after the intervention
Teen participants' confidence in their capacity to talk with a partner what they want and do not want in a relationship such as breaking up with someone they no longer like (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy).
Self-Efficacy for Consent
Time frame: immediately before and immediately after the intervention
Teen participants' confidence in their capacity to talk with a partner about consent, including asking for consent for sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy).
Self-Efficacy for Communication with Teens about Sex
Time frame: immediately before and immediately after the intervention
Father participants' confidence in their capacity to talk with their teen about sexual issues and relationships (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher self-efficacy).
Comfort Talking with Family about Sex
Time frame: immediately before and immediately after the intervention
Participants' comfort to talk with their father/teen about sexual issues and relationships for fathers and teens including being able to talk openly and honestly about sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher comfort).
Open Communication Scale
Time frame: immediately before and immediately after the intervention
Participants' comfort to talk with their father/teen about sex and relationships for fathers and teens including comfort talking through questions about sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating higher comfort).
Communication about Sex and Protection
Time frame: immediately before and immediately after the intervention
Participants' reported frequency of talk with their father/teen about sex and relationships including talking with your father/teen about how to use condoms (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication).
Communication with family about sex & relationships
Time frame: immediately before and immediately after the intervention
Participants' reported frequency of talk with their father/teen about sex and relationships including talk about value about sex and relationships (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication).
Frequency of Talk with Family about Sex and Relationships
Time frame: immediately before and immediately after the intervention
Participants' reported frequency of talk with their father/teen about sex and relationships including when it is ok to have sex (self-report, 4-point Likert scales with 1-4 score range with higher scores indicating more frequent communication).
Feasibility of Intervention Measure
Time frame: immediately after the intervention
Participants' experience of the program's accessibility including whether the program seems doable for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher feasibility).
Feasibility: Participants' experience of the program's ease
Time frame: immediately after the intervention
Participants' experience of the program's ease of use including whether the program was well-organized for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher feasibility).
Acceptability of Intervention Measure: whether participants approve of the program
Time frame: immediately after the intervention
Participants' experience of the program including whether they approve of the program for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher acceptability).
Intervention Acceptability and Tolerability: Participants' experience of the program's importance
Time frame: immediately after the intervention
Participants' experience of the program's importance including whether they think the program was helpful for fathers and teens (self-report, 5-point Likert scales with 1-5 score range with higher scores indicating higher acceptability).
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 9 Apr 2025.
- Individual participant dataSharing planned: Yes. Documentation to be made publicly available to the research community will include pilot surveys and interview protocols, along with a detailed User Guide for interviews. A survey codebook will include a description of all items and survey measures as well as variable names, variable labels, and standard codes for missing values. Interview data will include a description of recoded data categories. We expect study data and associated documentation will be made available to the research community free of charge through the Inter-university Consortium for Political and Social Research (ICPSR).
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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 Pilot program study in people with Program, Communication, run by Wellesley College 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 9 Apr 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 Jennifer Grossman, Ph.D. (781-283-2521, jgrossma@wellesley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual knowledge (time frame: immediately before and immediately after the intervention). The study lists 14 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 9 Apr 2025.