NCT05143437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 2, 2021

Last Update Submit

November 29, 2021

Conditions

Family ConflictInternet-Based Intervention

Keywords

Couples' relationshipsFamily SystemsWriting InterventionNon-randomisedFeasibility study

Outcome Measures

Primary Outcomes (15)

  • Participants Accessed Per Week

    Number of participants accessed (I.e., initiate registration) per week, stratified by recruitment source.

    Week 0

  • Couple "we-ness"

    Assessing couple "we-ness" using a content analysis of writing samples collected during the intervention.

    Week 1-5

  • Appropriateness of Eligibility Criteria

    Percentage of interested participants that meet inclusion criteria (with reasons for exclusion).

    Week 0

  • Participant Income

    The percentage of participants income that is less than or equal to the regional median.

    Week 0

  • Retention

    The percentage of participants who remain in study until the end of the post-intervention assessment.

    Week 6

  • Uptake

    The percentage of participants reporting some use of conflict reappraisal outside of sessions.

    Week 3-5

  • Adherence

    The percentage of participants who complete 2/3 intervention sessions.

    Week 1-5

  • Acceptability

    Looking for the percentage of participants reporting at least 'good' on 80 % or more indicators on an Implementation Acceptability Scale that will assess attitude, burden, perceived effectiveness, and ethicality. Minimum score=7, maximum score=35. Higher scores correspond to better outcomes.

    Week 6

  • Participants Enrolled Per Week

    Number of participants enrolled per week, stratified by recruitment source.

    Week 0

  • Participant Education

    The percentage of participants with less than or equal to a high school degree.

    Week 0

  • Racial Diversity

    The percentage of participants who are a racial minority.

    Week 0

  • Immigrant Status

    The percentage of participants who are an immigrant.

    Week 0

  • Sexual Diversity

    The percentage of participants who are gender and/or sexually diverse.

    Week 0

  • Risk for Relationship Distress - Dyadic Adjustment

    The percentage of participants scoring in the 'clinical' range (\>13) on the Dyadic Adjustment Scale. Minimum score=1, maximum score=22. Higher scores correspond to worse outcomes.

    Week 0

  • Risk for Relationship Distress - COVID-19 Family Stressors

    The percentage of participants scoring 'high' (\>29) on the COVID-19 Family Stressor Scale. Minimum score=16, maximum score=48. Higher scores correspond to worse outcomes.

    Week 0

Secondary Outcomes (7)

  • Pre-Post Change in Parent Mental Health

    Pre-post change from week 0 to week 6.

  • Pre-Post Change in Parent-Child Relations

    Pre-post change from week 0 to week 6.

  • Pre-Post Change in Couples' Relationship Quality

    Pre-post change from week 0 to week 6.

  • Pre-Post Change in Conflict-Related Negativity

    Pre-post change from week 0 to week 6.

  • Pre-Post Change in Perceived Partner Responsiveness

    Pre-post change from week 0 to week 6.

  • +2 more secondary outcomes

Study Arms (1)

Writing Intervention

EXPERIMENTAL

Couples will take part in three 7-minute online writing sessions over the course of four weeks.

Behavioral: Love Together Parent Together

Interventions

Love Together Parent TogetherBEHAVIORAL

A brief, low-intensity writing intervention adapted for parents of young children, designed to reduce conflict-related distress, prevent relationship deterioration and encourage the use of conflict reappraisal strategies designed to reduce conflict-related distress, etc.

Also known as: L2P2
Writing Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35933434DERIVED

Study Officials

  • Heather Prime, PhD

    York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 2, 2021

First Posted

December 3, 2021

Study Start

August 26, 2021

Primary Completion

November 14, 2021

Study Completion

November 14, 2021

Last Updated

December 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)