Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT07125118
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-helpinterventions for Parenting Couples With Couple Distress.
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Self-help Interventions for Parenting Couples Experiencing Couple Distress: Study Protocol for a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 157457 | OTHER_GRANT | Trygfonden | View |