Clinical trial NCT05143437: Love Together, Parent Together: A Feasibility Study
Official title: Love Together, Parent Together (L2P2): A Feasibility Study of an Ultra-brief Couples Conflict Program for Parents of Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Conflict
Internet-Based Intervention
Keywords: Couples' relationships
Family Systems
Writing Intervention
Non-randomised
Feasibility study
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: McMaster University
First posted: 2021-12-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The COVID-19 pandemic has introduced additional stressors and challenges to couples' relationships, with potential ripple effects across all family subsystems and child adjustment. Among those who are particularly vulnerable to heightened conflict and lower relationship satisfaction during this time are couples with young children, whose relationships may have already been tenuous prior to the pandemic. The Love Together Parent Together (L2P2) program is a brief, low-intensity writing intervention adapted for parents of young children, designed to reduce conflict-related distress and prevent relationship deterioration. Based on an original writing program by Finkel and colleagues, adaptations include intervention duration and study population. The current study will examine key feasibility metrics related to this adapted intervention program with the goal of identifying problems and informing parameters of future pilot and/or main randomized controlled trials (RCT). The current study is a non-randomised feasibility study, using a single-arm, pre-test/post-test design to primarily assess the feasibility of a large trial, and secondarily to assess the potential effects on outcomes to be used in a future RCT. Couples will be recruited through three community-based agencies with the goal of obtaining a socio-demographically diverse sample. The first 20 couples to enroll will be included. Baseline and post-intervention surveys will be conducted, and a writing intervention will take place (three 7-minute sessions over the course of four weeks). The primary feasibility metrics will include recruitment rates, appropriateness of eligibility criteria, sample diversity, retention, uptake, and adherence, and acceptability. In addition, the researchers will develop an objective primary outcome measure of couple "we-ness" based on analysis of writing samples. The secondary outcomes will include couples' measures (i.e., relationship quality, perceived partner responsiveness, self-reported partner responsiveness, conflict-related distress), and other family outcomes (i.e., parent-child relations, parental/child mental health, and parenting practices). Criteria for success are outlined and failure to meet criteria will result in adaptations to measurement schedule, intervention design, recruitment approaches, and/or other elements of the study design. This feasibility study will inform several components of the procedures used for a subsequent pilot RCT, which will examine the feasibility of the methodology used to evaluate the program (e.g., randomization, attrition to follow up assessment/across groups, and sample size estimation, preliminary effectiveness), and a main trial, which will investigate the effectiveness of the intervention on primary outcome measures as well as mediating pathways.

Detailed description: See attached protocol.

Eligibility criteria: Inclusion Criteria:

* Both participants endorse being in a relationship
* Both partners reside in the same home
* There are one or more children under the age of 6 living at home
* Both participants are over age 18 years
* Both members of a couple agree to participate

Exclusion Criteria:

• No current plans or history of separation or divorce as this is meant to be a secondary preventative intervention for couples experiencing some but not severe relationship difficulties.

Primary outcomes:
measure: Participants Accessed Per Week
timeFrame: Week 0
measure: Couple "we-ness"
timeFrame: Week 1-5
measure: Appropriateness of Eligibility Criteria
timeFrame: Week 0
measure: Participant Income
timeFrame: Week 0
measure: Retention
timeFrame: Week 6
measure: Uptake
timeFrame: Week 3-5
measure: Adherence
timeFrame: Week 1-5
measure: Acceptability
timeFrame: Week 6
measure: Participants Enrolled Per Week
timeFrame: Week 0
measure: Participant Education
timeFrame: Week 0
measure: Racial Diversity
timeFrame: Week 0
measure: Immigrant Status
timeFrame: Week 0
measure: Sexual Diversity
timeFrame: Week 0
measure: Risk for Relationship Distress - Dyadic Adjustment
timeFrame: Week 0
measure: Risk for Relationship Distress - COVID-19 Family Stressors
timeFrame: Week 0
Secondary outcomes:
measure: Pre-Post Change in Parent Mental Health
timeFrame: Pre-post change from week 0 to week 6.
measure: Pre-Post Change in Parent-Child Relations
timeFrame: Pre-post change from week 0 to week 6.
measure: Pre-Post Change in Couples' Relationship Quality
timeFrame: Pre-post change from week 0 to week 6.
measure: Pre-Post Change in Conflict-Related Negativity
timeFrame: Pre-post change from week 0 to week 6.
measure: Pre-Post Change in Perceived Partner Responsiveness
timeFrame: Pre-post change from week 0 to week 6.
measure: Pre-Post Change in Child Emotional and Behavioural Problems
timeFrame: Pre-post change from week 0 to week 6.
measure: Pre-Post Change in Responsiveness Towards Partner
timeFrame: Pre-post change from week 0 to week 6.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Heather Prime, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prime H, Muise A, Benyamin V, Thabane L, Wade M. Love Together, Parent Together (L2P2): a protocol for a feasibility study of a conflict reappraisal writing intervention for interparental couples with young children. Pilot Feasibility Stud. 2022 Aug 6;8(1):170. doi: 10.1186/s40814-022-01115-y.