STORK (Supporting the Transition to Parenthood Through Online Sex and Relationship Knowledge) Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 4
- 主要终点
- Sexual Satisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
STORK Program
STORK online prevention program
干预措施: STORK Program (Other)
Waitlist Control
Waitlist control comparison group
结局指标
主要结局
Sexual Satisfaction
时间窗: 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).
Sexual Distress
时间窗: 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).
Sexual Desire
时间窗: 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).
次要结局
- 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)
研究者
Natalie Rosen
Professor
Dalhousie University
