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Идёт набор NCT07125118

Self-helpinterventions for Parenting Couples With Couple Distress.

Без фазы С лечением Marital Conflict

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: The OurRelationship Program, Bibliotherapy.
Кому может быть актуально
Состояния в реестре: Marital Conflict. 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Self-help Interventions for Parenting Couples Experiencing Couple Distress: Study Protocol for a Randomized Controlled Trial

Обзор

Children whose parents experience high levels of couple distress are at greater risk for emotional, behavioral, and academic problems. This study tests two types of self-help for parenting couples: the OurRelationship program (OR), an online guided program, and couple-focused bibliotherapy (BT), a book-based self-help approach. The investigators will compare these interventions with a waitlist (WL) control group to see which is most effective at reducing communication conflict between partners. They will also examine whether the interventions improve child well-being when problems are present at the start of the study. A total of 350 parenting couples in Denmark will take part. Eligible couples have at least one child under 18 living at home and report high levels of conflict or relationship distress. Couples will be randomly assigned to OR, BT, or WL. Questionnaires will be completed online before the program, after the program (10 weeks later), and at 3- and 12-month follow-ups.

Подробное описание

Children exposed to high levels of couple distress are at increased risk for a range of adjustment problems, including behavioral, emotional, and academic difficulties. These relational burdens can also interfere with adult mental health, the coparenting relationship, and the capacity to provide warm and consistent caregiving. Despite these challenges, many couples delay seeking help until their relationship has seriously deteriorated.

This randomized controlled trial investigates the efficacy of two flexible self-help interventions: the OurRelationship program (OR) and couple-focused bibliotherapy (BT). The investigators hypothesize that OR will outperform BT, which in turn will outperform a waitlist (WL) control in reducing communication conflict-the primary outcome-between baseline and post-intervention. The investigators further hypothesize that any couple intervention (OR or BT) will outperform WL in reducing the impact on child well-being-the secondary outcome-between baseline and post-intervention for children showing such impact at baseline.

Parenting couples (N = 350) with one or more children living at home, who report either high levels of parental conflict or relationship distress, are recruited via municipal family services in 11 or more Danish sites. Participants enroll through an online platform, complete a screener, provide informed consent, and fill out a baseline survey before randomization. Families are randomly assigned in a 1:1:1 ratio to OR, BT, or WL. Online questionnaires are completed at baseline (T1, before randomization), post-intervention (T2, 10 weeks after randomization), and at 3-month and 12-month follow-ups (T3 and T4, respectively).

Dyadic multilevel models, with repeated measures (Level 1) nested within couples (Level 2), will be used to examine group differences in change trajectories across time for continuous outcomes. Including both a BT condition and a WL control allows the investigators to test whether OR offers added benefit over an accessible low-tech self-help option. Apart from the previous pilot, this is the first trial to evaluate OR independently of its developers and the first study conducted outside the United States.

Вмешательства

  • Поведенческое The OurRelationship Program
    A guided self-help program for couples delivered online over 10 weeks. Participants complete structured learning modules and engage in planned couple conversations focused on improving communication, problem-solving, and emotional connection. Each couple receives support from a trained coach through five scheduled telephone or video calls. The program is designed to be flexible and completed at the couple's own pace within the 10-week period.
  • Поведенческое Bibliotherapy
    An unguided self-help program for couples using the Danish book "Take Care of Your Relationship" \[Pas på Parforholdet\] and an accompanying reading guide. Couples are encouraged to read assigned sections, engage in planned couple conversations, and apply strategies for improving relationship functioning. The intervention is self-paced and completed over 10 weeks without guidance from a coach or therapist.

Первичные конечные точки

  • Communication Conflict Scale [Срок оценки: Pre-assessment (T1) to Post Intervention at Week 10 (T2)]
Вторичные конечные точки (1)
  • The Strengths and Difficulties Questionnaire (SDQ) - impact score [Срок оценки: Baseline (T1) to Post-intervention at Week 10 (T2)]

Критерии участия

Критерии включения

  • Meet at least one of the two following criteria: (1) Destructive conflict: one or both partners report being a victim or perpetrator of at least one act of physical or psychological aggression in the past three months (see exclusion criteria for intimate partner violence) OR (2) Couple distress: One partner scores ≤11 (1 SD below the Danish population mean), or both partners score ≤13 (0.5 SD below the Danish population mean) on the Couple Satisfaction Index-4 (CSI-4).
  • Both partners are at least 18 years old.
  • Cohabiting.
  • Have at least one child under 18 living at home.
  • Reside in a participating Danish municipality.
  • Completed the baseline survey.
  • Able to read and understand Danish.
  • Have internet access and a compatible device (computer, tablet, or smartphone).
  • Agree not to engage in couple therapy prior to the 3-month follow-up.

Критерии исключения

  • Current plans to divorce or separate.
  • Ongoing affair.
  • Moderate to severe suicidal ideation.
  • Recent incident of intimate partner violence resulting in physical injury or fear for the safety or well-being of oneself or one's children.

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
Открытое
Основная цель
Лечение

Центры проведения

Дания · 1 центр
  • Aarhus University — Aarhus

Публикации

  • Trillingsgaard T, Lassen NF, Baucom KJW, Svare LT, Hansen FG, Fentz HN. Self-help interventions for parenting couples experiencing conflict or relationship distress: study protocol for a randomized controlled trial. Trials. 2026 Jan 13;27(1):117. doi: 10.1186/s13063-026-09428-6. PMID 41530873

Идентификаторы

NCT: NCT07125118 · BSS-2024-018-S2 · 157457

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗