Love Together, Parent Together: A Protocol for a Pilot Study of an Intervention for Interparental Couples With Young Children (L2P2)

January 19, 2023 updated by: Heather Prime, York University

Love Together, Parent Together (L2P2): A Protocol for a Pilot RCT of a Brief Writing Intervention for Interparental Couples With Young Children Amid the COVID-19 Pandemic

The COVID-19 pandemic has created a population-level threat to social relationships that requires a population-level solution. Among those who are particularly vulnerable to heightened conflict are interparental couples with young children, whose relationships may have already been under pressure prior to the pandemic. Reduced couples' satisfaction has been reported since the start of the pandemic, with over one-third of romantic partners reporting heightened conflict due to COVID-19. Couples are likely to stay in disharmonious relationships during times of socioeconomic upheaval, with the potential for relationship problems to persist over time. This may have serious implications for the mental health of parents, parent-child relationships, and children's emotional and behavioural problems (EBPs). Such a pattern is a societal concern given the known associations between couples' relationship quality and a number of critical indicators of population health, such as intimate partner violence, physical health and all-cause mortality, and economic instability, particularly for women. The current study protocol is for a pilot randomized controlled trial (RCT) of the Love Together Parent Together (L2P2) program-a brief, low-intensity, scalable relationship intervention for parents of young children. The two-arm (treatment vs. waitlist) pilot RCT will assess the feasibility goals: continued relationship-building with established recruitment partners and outreach to additional recruitment partners to increase enrolment rates; recruitment of a diverse sample in terms of sociocultural identity factors, pandemic-related stress, and relationship distress; acceptability of randomization; outcome assessment schedule completion (for treatment and control groups), retention and adherence to the program; and program acceptability. Additionally, the investigators will conduct a preliminary evaluation of treatment effects by examining group differences in couples-focused (i.e., couples' relationship, conflict-related negativity, interparental functioning) and family-focused outcomes (i.e., parent-child relations, parent mental health and child outcomes). A scalable couples-focused intervention is critically needed to circumvent the social consequences of the pandemic on young families.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

240

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 house
  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Love Together, Parent Together Intervention
Participants will take part in a 3-session writing intervention over the course of 12-week. They will complete a fact-based summary of a recent conflict and answer questions on conflict/conflict-related distress. Next, they will be asked to complete a 9-minute writing task where they reappraise the conflict they previously reported. First, they will watch an instructional video of how to engage in the writing task, by providing definitions and examples of potentially useful conflict reappraisal strategies. Writing prompts include: "… Think about this disagreement … from the perspective of a neutral third party who wants the best for all involved…"; "…what obstacles do you face in trying to take this perspective…?";"… How might you be most successful in taking this perspective … over the next 2 weeks?" Participants in the intervention group will receive emails to prompt use of the reappraisal strategy between writing sessions.
Love Together Parent Together (L2P2) is a brief, low-intensity relationship intervention intended to improve the interparental relationship for parents of young children.
Other Names:
  • L2P2
No Intervention: Wait-List Control Group

Participants will take part in a waitlist control group. They will participate in the same number of assessment/sessions as the experimental group. In the sessions that correspond to the intervention (one session every 4 weeks over the course of 12 weeks as in the intervention group), the waitlist group will complete a basic writing task (identical to the intervention group, wherein they provide a fact-based summary of a recent conflict) and they will complete questions regarding conflict history and conflict-related distress. No other writing tasks will take place.

Following the 3-month assessment, they will be offered the writing intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk for Relationship Distress - Dyadic Adjustment Scale
Time Frame: Week 0-22
The percentage of participants scoring in the 'clinical range' (<13) on the Dyadic Adjustment Scale. Minimum score=1, maximum score=22. Lower scores correspond to worse outcomes.
Week 0-22
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
COVID Coping/Benefits
Time Frame: Week 0
Background information. Minimum score=14, maximum score=42 . Higher scores correspond to better outcomes.
Week 0
Adverse Childhood Experiences
Time Frame: Week 0
Background information. Adverse Childhood Experiences Scale. Minimum score=0, maximum score=14. Higher scores correspond to higher ACES count.
Week 0
Participants Enrolled Per Week
Time Frame: Week 0
Number of participants enrolled per week, stratified by recruitment source.
Week 0
Participant Education
Time Frame: Week 0
The percentage of participants with less than or equal to a College degree.
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
Racial Diversity
Time Frame: Week 0
The percentage of participants who identify as part of a racialized group.
Week 0
Sexual Diversity
Time Frame: Week 0
The percentage of participants who are gender and/or sexually diverse.
Week 0
Immigration Status
Time Frame: Week 0
The percentage of participants who were born outside of Canada.
Week 0
Adherence
Time Frame: Week 1-9
The percentage of participants who complete 2/3 intervention sessions.
Week 1-9
Acceptability
Time Frame: Week 10
The percentage of participants reporting at least 'agree' on scales of attitude, burden, perceived effectiveness, and ethicality on the Implementation Acceptability Scale. Minimum score=7, maximum score=35. Higher scores correspond to higher acceptability.
Week 10
Uptake
Time Frame: Week 5-22
The percentage of participants reporting some use of conflict reappraisal outside of intervention sessions (i.e., reporting a score of 3 or more on a scale of 1-7). Minimum score=1, maximum score=7. Higher scores correspond to better outcomes.
Week 5-22
Retention
Time Frame: Week 22
The percentage of participants who complete their Randomly Allocated Assignment (defined as completing baseline, 2/3 writing sessions, post-intervention, and 1/2 follow-up surveys).
Week 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Couples' Relationship Quality
Time Frame: Week 0-22
Using the Perceived Relationship Quality Scale. Minimum score=18, maximum score=126. Higher scores correspond to better outcomes.
Week 0-22
Conflict Frequency
Time Frame: Week 0-22
Using one item on a 7-point Likert scale: "Think about your experiences with your partner over the last four weeks. How often did you and your partner argue with each other?" Minimum score=1, maximum score=7. Higher scores correspond to worse outcomes.
Week 0-22
Conflict-Related Negativity
Time Frame: Week 1-9
Using two items following a 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.
Week 1-9
Coparenting
Time Frame: Week 0-22
The Brief Coparenting Relationship Scale. Minimum score=0, maximum score=84. Higher scores correspond to better outcomes.
Week 0-22
Brief Coparenting Assessment
Time Frame: Week 1-9
Six items from the Brief Coparenting Relationship Scale (Feinberg et al., 2012). Minimum score = 0, maximum score = 36. Higher scores correspond to better outcomes.
Week 1-9
Parent-Child Positivity
Time Frame: Week 0-22
Using the 5-item parent-reported positivity subscale of the Parenting Practices Scale. Minimum score=5, maximum score=25. Higher scores correspond to better outcomes.
Week 0-22
Parent-Child Negativity
Time Frame: Week 0-22
Using the 5-item parent-reported negativity subscale of the Parenting Practices Scale. Minimum score=5, maximum score=25. Higher scores correspond to worse outcomes.
Week 0-22
Parent Mental Health
Time Frame: Week 0-22
Using the Kessler Psychological Distress Scale. Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.
Week 0-22
Perceived Partner Responsiveness
Time Frame: Week 0-22
Using the Perceived Partner Responsiveness-Insensitivity Scale (PRI-R)- Brief Version. Minimum score=8, maximum score=40. Higher scores correspond to better outcomes.
Week 0-22
Responsiveness Towards Partner
Time Frame: Week 0-22
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.
Week 0-22
Family Functioning
Time Frame: Week 0-22
Using the Family Assessment Device. Minimum score=12, maximum score=48. Higher scores correspond to worse outcomes.
Week 0-22
Child Emotional and Behavioural Problems
Time Frame: Week 0-22

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 Symptoms 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.

Week 0-22
Child Effortful Control
Time Frame: Week 0-22
Using the Effortful Control subscale (12 items) of the Infant Behaviour Questionnaire- Revised Very Short Form (3-12 months), Early Childhood Behavior Questionnaire-Revised Very Short Form (18-36 months) and Children's Behaviour Questionnaire-Revised Very Short Form (3-7 years). Minimum score=0 , maximum score=84. Higher scores correspond to better outcomes.
Week 0-22
Child Development
Time Frame: Week 0-22
Using the 10-item Developmental Milestones scale from The Survey of Well-being of Young Children (i.e., the 2, 4, 6, 9, 12, 15, 18, 24, 30, 36, 48 and 60 month age-specific forms). Minimum score=0, maximum score =20. Higher scores correspond to better outcomes.
Week 0-22

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

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)

April 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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