NCT07344454

Brief Summary

Becoming parents exerts powerful and long-lasting effects on couples' well-being and quality of life. The transition to parenthood (TtP; pregnancy to 12-months postpartum) poses significant challenges as couples balance the task of caring for a newborn while maintaining their romantic relationship. One crucial way that couples sustain their connection is through their sexuality. Most new parents experience significant disruptions to their sexual well-being (i.e., sexual satisfaction, desire, distress), with sexual concerns such as reduced sexual frequency and lack of time and energy for sex being nearly ubiquitous. Simultaneously, most new parents lack easily accessible, reliable information on the common sexual changes associated with the TtP and there is a lack of evidence-based research aimed at helping couples navigate changes to their sexual well-being across this life transition. The investigators have identified risk (e.g., stress) and protective (e.g., intimacy) factors for couples' sexual well-being across the TtP that can be targeted in a prevention program, though no such programs exist. The goal of this two-centre randomized controlled trial is to evaluate the efficacy of STORK (Supporting the Transition to Parenthood through Online Sex and Relationship Knowledge), a novel couple-based online program to support new parents' sexual well-being. This program comprises psychoeducation about common sexual changes as well as skills that couples can develop together to manage these changes and constitutes the first evidence-based program for new parent couples' sexual well-being. The investigators expect that, compared to a waitlist control group, couples who complete STORK will have better sexual, relational, and psychological adjustment across the transition to parenthood (from 13 to 27-weeks gestation to 12-months postpartum). Given that up to 78% of new parents report receiving little-to-no information about what to expect regarding changes to their postpartum sexual relationship, this study addresses the need for accessible, couple-based supports for this commonly challenging transition. By strengthening couples' sexual relationships, the results of this research have the potential to promote the quality of new parents' relationships, strengthening the overall well-being of their families during this critical life stage.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
268

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
35mo left

Started Jan 2026

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Mar 2029

Study Start

First participant enrolled

January 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

3.2 years

First QC Date

January 7, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

Transition to parenthoodsexual well-beingcouplesparents

Outcome Measures

Primary Outcomes (3)

  • Sexual Satisfaction

    The Global Measure of Sexual Satisfaction Scale consists of five items assessing a subjective evaluation of the sexual relationship: good vs. bad, pleasant vs. unpleasant, positive vs. negative, satisfying vs. unsatisfying, and valuable vs. worthless (Lawrance \& Byers, 1995). Ratings are summed where possible scores range from 5 to 35, with higher scores indicating greater sexual satisfaction. This measure has demonstrated excellent psychometrics in previous studies (e.g., Paquette et al., 2025).

    Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups

  • Sexual Distress

    Sexual distress will be assessed with the 3-item Sexual Distress Scale-3 (Derogatis, 2008; Lin et al., 2024). Using a 5-point Likert scale, participants rate how frequently (e.g., 0 = never, to 4 = always) they experience a sexuality related problem. Ratings are summed such that possible scores range from 0 to 12, with higher scores indicating greater sexual distress. This measure has demonstrated good psychometrics in differentiated individuals who did and did not experience sexual problems (Lin et al., 2024).

    Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups

  • Sexual Desire

    Sexual desire will be measured using 7-items of partner-focused sexual desire from the Sexual Desire Inventory (Moyano et al., 2017). Participants rate their interest in sexual activity using a Likert-type response scale from 0 (e.g., not at all) to 7 or 8 (e.g., a lot). Ratings are summed (range = 0 to 54) such that higher scores indicate greater sexual desire for one's partner. This measure has demonstrated good psychometrics (Moyano et al., 2017).

    Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups

Secondary Outcomes (4)

  • Depressive Symptoms

    Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups

  • Anxiety Symptoms

    Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups

  • Relationship Satisfaction

    Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups

  • Relationship Conflict

    Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups

Study Arms (2)

STORK Program

EXPERIMENTAL

STORK online prevention program

Other: STORK Program

Waitlist Control

NO INTERVENTION

Waitlist control comparison group

Interventions

The STORK program includes a brief orientation module (Module 0, intended to be completed in the same sitting as Module 1) followed by six full-length modules: five weekly modules in pregnancy (Modules 1 to 5) and one module at 3-months postpartum (Module 6). Couples are assigned a trained facilitator (undergraduate research assistant, graduate student, or postdoc) to answer questions or resolve any technical issues.

STORK Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • married or cohabitating romantic relationship of at least 12 months
  • one member of the couple must be currently pregnant (13-27 weeks gestation) with their first baby together (If the couple has a history of miscarriage or stillbirth, previously gave a baby up for adoption, or have other children who do not live with them, they are still eligible to participate.)
  • low-risk pregnancy
  • live in Canada, the United States, Australia, New Zealand, the Republic of Ireland, or the United Kingdom
  • able to read and understand English
  • have access to a personal e-mail account

You may not qualify if:

  • severe relational distress or conflict as determined by baseline measures
  • one or both partners of a couple do not complete the baseline survey - this includes cases where one or both partners do not pass at least 3/5 attention checks in the baseline survey
  • instructed to avoid sexual activity from a healthcare professional

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H4R2, Canada

Location

Central Study Contacts

Natalie O Rosen, PhD

CONTACT

Gillian K Hyslop, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A free randomization software (www.studyrandomizer.com) will be used for randomization. At each site, allocation will be computer-generated randomly using permuted blocks of size 6 (fixed) to maintain equilibrium between the two conditions (experimental and control). Participants will be instructed not to reveal the condition they are in to the researchers. To that end, participants in the experimental condition will be instructed to contact a separate email address for questions concerning the STORK program that does not go to the main study email. This procedure ensures that the personnel conducting reminder calls for the surveys or conversing with participants via email will not be aware of participant condition and that the PIs will not influence the randomization process. Only the research coordinators (one per site) conducting the randomizations and the STORK facilitators who support couples in the experimental condition will not be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The randomized controlled trial will evaluate the efficacy of a novel 6-module online psychoeducational program (STORK) for couples undergoing the transition to parenthood compared to a waitlist control group. Couples in the program (i.e., experimental) group will receive access to the STORK program. Couples in the waitlist control group will complete all questionnaires at the equivalent timepoints as the experimental group and, at the end of the 12-month follow-up, will also receive access to the STORK program for 6 months at no cost.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

January 16, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

When publishing findings in scientific journals, the investigators will upload limited de-identified datasets specific to the analyses in question via the Open Science Framework (OSF) platform.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The study protocol will be published in a scientific journal while data collection is still ongoing. The datasets for each publication will be uploaded to OSF after the respective analysis is complete and will remain on OSF indefinitely.
Access Criteria
Researchers outside the research teams at Dalhousie University or the University of British Columbia will be able to access the uploaded datasets on the OSF. The data that will be shared on the OSF website will only contain the variables relevant to the analysis in question and will not contain any information that could identify the participants. Further, it will be password protected such that interested researchers will have to contact the research team for the password. Datasets may be inspected and analyzed by other researchers for the purposes of reproduction and verification of our findings, necessitating all responses included in the analysis to be included in the uploaded dataset.

Locations