Меню
Набор скоро начнётся NCT07344454

Supporting the Transition to Parenthood Through Online Sex and Relationship Knowledge

Без фазы С лечением Pregnancy Postpartum

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: STORK Program.
Кому может быть актуально
Состояния в реестре: Pregnancy, Postpartum. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

STORK (Supporting the Transition to Parenthood Through Online Sex and Relationship Knowledge) Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое STORK 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.

Первичные конечные точки

  • Sexual Satisfaction [Срок оценки: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups]
  • Sexual Distress [Срок оценки: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups]
  • Sexual Desire [Срок оценки: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups]
Вторичные конечные точки (4)
  • Depressive Symptoms [Срок оценки: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups]
  • Anxiety Symptoms [Срок оценки: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups]
  • Relationship Satisfaction [Срок оценки: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups]
  • Relationship Conflict [Срок оценки: Baseline, 32-weeks gestation, and 4-, 8-, and 12-month follow-ups]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Канада · 2 центра
  • University of British Columbia — Vancouver
  • Dalhousie University — Halifax

Идентификаторы

NCT: NCT07344454 · 2025-7940 · 435-2023-0235

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗