PregnancyNCT07036484
Supporting Couples' Perinatal Sexual Well-being: Testing the Introductory Modules of a Novel Prevention Program (STORK)
An observational study of Pregnancy, run by Dalhousie University at 1 site in Canada.
Trial summary
Most new parents will experience changes to their sexual relationship during the perinatal period, yet no accessible prevention programs exist to support couples in navigating these changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pregnancy
- What is being tested?
- Online program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 11 Aug 2023to 8 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult couples who are in a cohabiting committed relationship with each other and are expecting their first baby (between 12-25 weeks gestation).
Who may be able to join
- both partners are at least 18 years of age
- both partners speak and read English fluently
- both partners live together and are in a relationship with each other for at least 1 year
- one partner is 12-25 weeks pregnant with both partner's first child
Who cannot join
- couples were instructed by a healthcare professional to avoid sexual activity during pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting Couples' Perinatal Sexual Well-being: A Pilot Feasibility Study of the Introductory Modules of a Novel Prevention Program (STORK)
Most new parents will experience changes to their sexual relationship during the perinatal period, yet no accessible prevention programs exist to support couples in navigating these changes. The goal of this observational study is to test the feasibility of the introductory modules of an online program (STORK) designed to promote perinatal sexual well-being in a sample of expectant couples. The main question it aims to answer is:
Is STORK a feasible and acceptable resource to support couples' perinatal sexual well-being? Couple participants who complete the first two modules of the STORK program will answer online survey questions and an interview about their experience with the program.
- Conditions
- Pregnancy
- Being tested
- Online program
- Keywords
- pregnancy, postpartum, perinatal, transition to parenthood, psychoeducation, internet intervention, prevention, sexual wellbeing, sexual health, couple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online programBehavioural
We tested the feasibility of the introductory modules of an online couple-based program (STORK), designed to be grounded in empirically established risk and protective factors associated with couples' perinatal sexual well-being. STORK is a web-based program including psychoeducation and behavioral tasks to be completed by couples
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
After completing the initial STORK program's modules, couples self-reported on acceptability of the platform using 11 researcher-derived items modeled after prior similar work. Items assessed aspects such as enjoyment, overall organization, and amount of information for Module 0 and Module 1 using 7-point Likert-type response scales. Participants also provided open-ended suggestions for improvement.
Measured: At entry (around 20 weeks gestation)
Content and layout
Participants self-reported on 9 researcher-derived items assessing the content and layout of information presented in the STORK program such as platform layout, clarity and appropriateness of content using 7-point Likert-type response scales. Three open-ended questions asked about areas that were covered well, areas of improvement, and confusing terms/ideas.
Measured: At entry (around 20 weeks gestation)
Functionality
Two researcher-derived items assessed ease of navigation and the relevance of graphics (i.e., images/videos) using 7-point Likert-type response scales; an open-ended question asked about specific suggestions to functionality of the platform.
Measured: At entry (around 20 weeks gestation)
Inclusivity
Participants self-reported on their perceptions regarding inclusivity of the platform using 4 researcher-derived items completed on a 7-point Likert-type response scales. One open-ended question asked about specific suggestions to improve inclusivity of the program.
Measured: At entry (around 20 weeks gestation)
Time commitment
Participants self-reported how long it took them to complete the modules, and whether they considered this amount of time reasonable using a dichotomic (yes/no) item; if they responded negatively, then they were invited to provide reasons using an open-ended question.
Measured: At entry (around 20 weeks gestation)
Feasibility of the program's introductory modules - semi structured interview
After completing the module, a semi-structured interview was conducted. The interview included open-ended questions about the web platform, as well as specific questions regarding its content, relevancy, clarity, organization, aesthetics, navigation, and functionality.
Measured: At entry (around 20 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start11 Aug 2023
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Natalie O Rosen, Ph.D., Principal investigator, Dalhousie University, CanadaSamantha J Dawson, Ph.D., Principal investigator, University of British Columbia, CanadaInês M Tavares, Ph.D., Principal investigator, Lusófona University, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036484
- Sponsor's protocol ID
- 2023-6719
- Other IDs
- 435-2023-0235
- Status last verified
- Oct 2024
- First submitted
- 17 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tavares IM, Dawson SJ, Fitzpatrick ET, Jang GE, Stephenson KR, Rosen NO. Supporting couples' perinatal sexual well-being: a feasibility study of the introductory modules of a novel prevention program (STORK). Pilot Feasibility Stud. 2026 Jul 21. doi: 10.1186/s40814-026-01878-8. Online ahead of print.
PubMed 42477807
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Couples' Perinatal Sexual Well-being: A Pilot Feasibility Study of the Introductory Modules of a Novel Prevention Program (STORK)
- ClinicalTrials.gov ID
- NCT07036484
- Acronym / sponsor ID
- 2023-6719
- Conditions
- Pregnancy
- Keywords
- pregnancy, postpartum, perinatal, transition to parenthood, psychoeducation, internet intervention, prevention, sexual wellbeing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 25 Jun 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.
Most new parents will experience changes to their sexual relationship during the perinatal period, yet no accessible prevention programs exist to support couples in navigating these changes. The goal of this observational study is to test the feasibility of the introductory modules of an online program (STORK) designed to promote perinatal sexual well-being in a sample of expectant couples. The main question it aims to answer is:
Is STORK a feasible and acceptable resource to support couples' perinatal sexual well-being? Couple participants who complete the first two modules of the STORK program will answer online survey questions and an interview about their experience with the program.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult couples who are in a cohabiting committed relationship with each other and are expecting their first baby (between 12-25 weeks gestation).
Key inclusion criteria (4 listed)
- both partners are at least 18 years of age
- both partners speak and read English fluently
- both partners live together and are in a relationship with each other for at least 1 year
- one partner is 12-25 weeks pregnant with both partner's first child
Key exclusion criteria (1 listed)
- couples were instructed by a healthcare professional to avoid sexual activity during pregnancy
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 |
|---|---|---|
| Online programWe tested the feasibility of the introductory modules of an online couple-based program (STORK), designed to be grounded in empirically established risk and protective factors associated with couples' perinatal sexual well-being. STORK is a web-based program including psychoeducation and behavioral tasks to be completed by couples | Behavioural | – |
Primary outcome
Acceptability
Time frame: At entry (around 20 weeks gestation)
After completing the initial STORK program's modules, couples self-reported on acceptability of the platform using 11 researcher-derived items modeled after prior similar work. Items assessed aspects such as enjoyment, overall organization, and amount of information for Module 0 and Module 1 using 7-point Likert-type response scales. Participants also provided open-ended suggestions for improvement.
Content and layout
Time frame: At entry (around 20 weeks gestation)
Participants self-reported on 9 researcher-derived items assessing the content and layout of information presented in the STORK program such as platform layout, clarity and appropriateness of content using 7-point Likert-type response scales. Three open-ended questions asked about areas that were covered well, areas of improvement, and confusing terms/ideas.
Functionality
Time frame: At entry (around 20 weeks gestation)
Two researcher-derived items assessed ease of navigation and the relevance of graphics (i.e., images/videos) using 7-point Likert-type response scales; an open-ended question asked about specific suggestions to functionality of the platform.
Inclusivity
Time frame: At entry (around 20 weeks gestation)
Participants self-reported on their perceptions regarding inclusivity of the platform using 4 researcher-derived items completed on a 7-point Likert-type response scales. One open-ended question asked about specific suggestions to improve inclusivity of the program.
Time commitment
Time frame: At entry (around 20 weeks gestation)
Participants self-reported how long it took them to complete the modules, and whether they considered this amount of time reasonable using a dichotomic (yes/no) item; if they responded negatively, then they were invited to provide reasons using an open-ended question.
Feasibility of the program's introductory modules - semi structured interview
Time frame: At entry (around 20 weeks gestation)
After completing the module, a semi-structured interview was conducted. The interview included open-ended questions about the web platform, as well as specific questions regarding its content, relevancy, clarity, organization, aesthetics, navigation, and functionality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 42477807Tavares IM, Dawson SJ, Fitzpatrick ET, Jang GE, Stephenson KR, Rosen NO. Supporting couples' perinatal sexual well-being: a feasibility study of the introductory modules of a novel prevention program (STORK). Pilot Feasibility Stud. 2026 Jul 21. doi: 10.1186/s40814-026-01878-8. Online ahead of print.
- 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.
Natalie O Rosen, Ph.D. principal investigator
Dalhousie University, Canada
Samantha J Dawson, Ph.D. principal investigator
University of British Columbia, Canada
Inês M Tavares, Ph.D. principal investigator
Lusófona University, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Dalhousie University at 1 site in Canada.
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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: At entry (around 20 weeks gestation)). The study lists 6 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 NCT07036484, which also lists 1 linked publication.
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 2 Jul 2025.