Love Together, Parent Together: A Feasibility Study (L2P2)

November 29, 2021 updated by: Heather Prime, York University

Love Together, Parent Together (L2P2): A Feasibility Study of an Ultra-brief Couples Conflict Program for Parents of Young Children

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.

Study Overview

Detailed Description

See attached protocol.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M3J 1P3
        • York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Writing Intervention
Couples will take part in three 7-minute online writing sessions over the course of four weeks.
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.
Other Names:
  • L2P2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk for Relationship Distress - COVID-19 Family Stressors
Time Frame: Week 0
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
Participants Enrolled Per Week
Time Frame: Week 0
Number of participants enrolled per week, stratified by recruitment source.
Week 0
Participant Income
Time Frame: Week 0
The percentage of participants income that is less than or equal to the regional median.
Week 0
Sexual Diversity
Time Frame: Week 0
The percentage of participants who are gender and/or sexually diverse.
Week 0
Participants Accessed Per Week
Time Frame: Week 0
Number of participants accessed (I.e., initiate registration) per week, stratified by recruitment source.
Week 0
Couple "we-ness"
Time Frame: Week 1-5
Assessing couple "we-ness" using a content analysis of writing samples collected during the intervention.
Week 1-5
Appropriateness of Eligibility Criteria
Time Frame: Week 0
Percentage of interested participants that meet inclusion criteria (with reasons for exclusion).
Week 0
Retention
Time Frame: Week 6
The percentage of participants who remain in study until the end of the post-intervention assessment.
Week 6
Uptake
Time Frame: Week 3-5
The percentage of participants reporting some use of conflict reappraisal outside of sessions.
Week 3-5
Adherence
Time Frame: Week 1-5
The percentage of participants who complete 2/3 intervention sessions.
Week 1-5
Acceptability
Time Frame: Week 6
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
Participant Education
Time Frame: Week 0
The percentage of participants with less than or equal to a high school degree.
Week 0
Racial Diversity
Time Frame: Week 0
The percentage of participants who are a racial minority.
Week 0
Immigrant Status
Time Frame: Week 0
The percentage of participants who are an immigrant.
Week 0
Risk for Relationship Distress - Dyadic Adjustment
Time Frame: Week 0
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-Post Change in Parent Mental Health
Time Frame: Pre-post change from week 0 to week 6.
Using the Kessler Psychological Distress Scale. Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.
Pre-post change from week 0 to week 6.
Pre-Post Change in Parent-Child Relations
Time Frame: Pre-post change from week 0 to week 6.
Using the Parenting Practices Scale from the Ontario Child Health Study. Minimum score=11, maximum score=55. Higher scores correspond to better outcomes.
Pre-post change from week 0 to week 6.
Pre-Post Change in Couples' Relationship Quality
Time Frame: Pre-post change from week 0 to week 6.
Using the Perceived Relationship Quality Scale. Minimum score= 18, maximum score=126. Higher scores correspond to better outcomes.
Pre-post change from week 0 to week 6.
Pre-Post Change in Conflict-Related Negativity
Time Frame: Pre-post change from week 0 to week 6.
Using two items following fact-based summary: "I was angry at my partner for his/her behaviour during this conflict," "My partner's behaviour during this conflict was highly upsetting to me". Minimum score=2, maximum score=14. Higher scores correspond to worse outcomes.
Pre-post change from week 0 to week 6.
Pre-Post Change in Perceived Partner Responsiveness
Time Frame: Pre-post change from week 0 to week 6.
Using the Perceived Partner Responsiveness-Insensitivity Scale (PRI-R) - Brief Version. Minimum score=8, maximum score=40. Higher scores correspond to better outcomes.
Pre-post change from week 0 to week 6.
Pre-Post Change in Child Emotional and Behavioural Problems
Time Frame: Pre-post change from week 0 to week 6.

Scores will be standardized within each age group and used as a single outcome variable.

Using the Pediatric Symptom Checklist (Baby, Preschool, and Standard versions). The Baby Pediatric Symptom Checklist: Minimum score=0, maximum score=26. Higher scores correspond to worse outcomes.

The Preschool Pediatric Symptom Checklist (PPSC-17): Minimum score=0, maximum score=36. Higher scores correspond to worse outcomes.

The Pediatric Symptom Checklist-17: Minimum score=0, maximum score=34. Higher scores correspond to worse outcomes.

Pre-post change from week 0 to week 6.
Pre-Post Change in Responsiveness Towards Partner
Time Frame: Pre-post change from week 0 to week 6.
Using the Perceived Partner Responsiveness-Insensitivity Scale (PRI) - Brief with items flipped to reflect responsiveness towards partner. Minimum score=8, maximum score=40. Higher scores correspond to better outcomes.
Pre-post change from week 0 to week 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Heather Prime, PhD, York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2021

Primary Completion (Actual)

November 14, 2021

Study Completion (Actual)

November 14, 2021

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Family Conflict

Clinical Trials on Love Together Parent Together

Subscribe