- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344454
Supporting the Transition to Parenthood Through Online Sex and Relationship Knowledge (STORK)
STORK (Supporting the Transition to Parenthood Through Online Sex and Relationship Knowledge) Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. Sexual satisfaction is one of the top five predictors of relationship quality and is linked to lower perinatal anxiety, depression, and stress-all of which affect children's socioemotional development. 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. Indeed, up to 78% of new parents report receiving little-to-no information about what to expect regarding changes to their postpartum sexual relationship. However, this information is fundamental to establish realistic expectations and to successfully manage the sexual changes likely to occur. There is a lack of evidence-based research aimed at helping couples navigate changes to their sexual well-being across this life transition. Studies that do exist are small, atheoretical, lack postpartum follow-up and typically focus on new mothers, neglecting partners' experiences as well as the interdependency of couples' sexuality. 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 investigators have subsequently developed STORK (Supporting the Transition to Parenthood through Online Sex and Relationship Knowledge), a couple-based online program to support new parents' sexual well-being. STORK is rooted in scientific evidence drawn from our prior research identifying relevant protective and risk factors that are associated with changes in sexual well-being during the TtP. The 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 current study builds on a pilot study that found the STORK program was feasible and useful and supported the sexual well-being of new-parent couples from mid-pregnancy to 3-months postpartum.
The primary aim is to test the prediction that the STORK program will show efficacy in supporting the sexual adjustment of couples in the TtP, such that couples in the program group will report greater sexual satisfaction and desire and lower sexual distress at follow-up (4-months postpartum) and across the postpartum period (4, 8, and 12 months) relative to the control group. As the secondary aim, it is also predicted that couples in the program group will report better relational (i.e., greater relationship satisfaction and less relationship and sexual conflict) and psychological well-being (i.e., less symptoms of depression, anxiety) at follow-up (4-months postpartum) and across the postpartum period (4, 8, and 12 months) relative to the control group.
The investigators will (1) recruit an inclusive sample of 268 first-time expectant couples in their second trimester (13-27 weeks) of pregnancy; (2) randomize couples to either the STORK program or a waitlist control group; (3) have couples complete standardized, self-report measures at baseline (pre-program), 32-weeks gestation, 4-, 8-, and 12-months postpartum; (4) test the efficacy of STORK compared to the control group. Procedures will take place at Dalhousie University and the University of British Columbia.
This clinical trial addresses an important need for empirically validated, accessible, couple-based supports for the transition to parenthood-a time where couples commonly experience new sexual and relationship challenges. By strengthening couples' sexual relationships, the current research program has the potential to promote the quality of new parents' relationships, strengthening the overall well-being of their families during this critical life stage.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natalie O Rosen, PhD
- Phone Number: 902-494-4044
- Email: nrosen@dal.ca
Study Contact Backup
- Name: Gillian K Hyslop, BSc
- Phone Number: 902-494-4223
- Email: rosenlab@dal.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z4
- University of British Columbia
-
Contact:
- Samantha J Dawson, PhD
- Phone Number: 604-822-8377
- Email: sdawson@psych.ubc.ca
-
Contact:
- Ela Turkkan
- Phone Number: 604-822-4826
- Email: stork@psych.ubc.ca
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H4R2
- Dalhousie University
-
Contact:
- Natalie O Rosen, PhD
- Phone Number: 902-494-4044
- Email: nrosen@dal.ca
-
Contact:
- Gillian K Hyslop, BSc
- Phone Number: 902-494-4223
- Email: stork@dal.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STORK Program
STORK online prevention program
|
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.
|
|
No Intervention: Waitlist Control
Waitlist control comparison group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Desire
Time Frame: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
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
|
|
Sexual Satisfaction
Time Frame: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
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
Time Frame: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptoms
Time Frame: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
The Edinburgh Postnatal Depression Scale (EPDS; Cox, 1987) is a widely used 10-item measure designed to screen for perinatal depression in pregnancy and in parents with infants.
The EPDS asks individuals to answer how they have been feeling in the previous 7 days using a response scale from 0 (e.g.,
Not at all) to 3 (e.g., As much as I ever did), with questions involving common indicators of depression.
A total sum score is computed (range = 0 to 30) where higher scores indicate more depressive symptoms.
This measure has good psychometric properties (e.g., Kernot et al., 2014) and high sensitivity for detecting postnatal depression (e.g., Eberhard-Gran et al., 2001).
|
Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
|
Anxiety Symptoms
Time Frame: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
Anxiety symptoms will be measured using the 7-item GAD-7 (Spitzer et al., 2006), which assesses symptoms of generalized anxiety.
Participants rate the frequency of experiencing anxiety symptoms on a Likert scale from 0 (Not at all) to 3 (Nearly every day).
A total sum score is computed (range = 0 to 21) with higher scores indicating greater anxiety symptoms.
This measure has good psychometric properties (Spitzer et al., 2006).
|
Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
|
Relationship Satisfaction
Time Frame: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
Relationship satisfaction will be measured with the 4-item version of the Couples Satisfaction Index (CSI) developed by Funk and Rogge (Funk, 2007).
Participants rate their general relationship satisfaction, including how happy they are with their relationship, how frequently they disagree with their partner, and how they feel their relationship compares to others, using a 6- or 7-point Likert scale from 0 (e.g.,
Not at all true) to 5 or 6 (e.g., completely true).
A total sum score is computed (range = 0 to 21) where higher scores indicate greater relationship satisfaction.
The 4-item version has good psychometric properties and a cut-off for high relationship distress (Funk & Rogge, 2007).
|
Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
|
Relationship Conflict
Time Frame: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
Relationship conflict will be measured using 2 items assessing conflict in the relationship from the Revised Dyadic Adjustment Scale (Busby, 1995).
These items ask participants to report how often they argue with their partner or how often they get on each others' nerves.
To measure sexual conflict, the same two items were adapted to ask specifically about sex.
Participants respond using a Likert scale from 0 ("All the time) to 5 ("Never").
A total sum score is computed for each of relationship and sexual conflict (range = 0 to 10) where higher scores indicate less conflict.
|
Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-7940
- 435-2023-0235 (Other Grant/Funding Number: Social Sciences and Humanities Research Council of Canada (SSHRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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