NCT07036484

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

July 2, 2025

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

June 17, 2025

Last Update Submit

June 27, 2025

Conditions

Keywords

pregnancypostpartumperinataltransition to parenthoodpsychoeducationinternet interventionpreventionsexual wellbeingsexual healthcouple

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    At entry (around 20 weeks gestation)

Interventions

Online programBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • \- couples were instructed by a healthcare professional to avoid sexual activity during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 42R, Canada

Location

Study Officials

  • Natalie O Rosen, Ph.D.

    Dalhousie University, Canada

    PRINCIPAL INVESTIGATOR
  • Samantha J Dawson, Ph.D.

    University of British Columbia, Canada

    PRINCIPAL INVESTIGATOR
  • Inês M Tavares, Ph.D.

    Lusófona University, Portugal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

August 11, 2023

Primary Completion

December 8, 2023

Study Completion

December 8, 2023

Last Updated

July 2, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations