Clinical trial NCT05261022: Love Together, Parent Together: A Protocol for a Pilot Study of an Intervention for Interparental Couples With Young Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interparental Conflict
Marital Conflict
Marital Relationship
Internet-Based Intervention
Family Conflict
Keywords: Online Intervention
Family Systems
Randomized Controlled Trial
Writing Intervention
Couples' relationships
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: McMaster University
First posted: 2022-03-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current study is a two-arm (intervention vs. waitlist) design with pre-, 1-week post-, and 1- and 3-month follow-up assessments. The first 120 interparental couples who meet eligibility criteria and consent will be included in the study. The entirety of the study will be conducted online (via mobile or computer). The writing assignments (intervention vs. inactive-control task) will commence approximately one week following baseline surveys, which will include three writing sessions over the course of 12 weeks (one session every 4 weeks). Following the 3 month follow-up, couples randomised to the waitlist control condition will be invited to participate in the writing program (i.e., three writing sessions over the course of 12 weeks).
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Risk for Relationship Distress - Dyadic Adjustment Scale
timeFrame: Week 0-22
measure: Risk for Relationship Distress - COVID-19 Family Stressors
timeFrame: Week 0
measure: COVID Coping/Benefits
timeFrame: Week 0
measure: Adverse Childhood Experiences
timeFrame: Week 0
measure: Participants Enrolled Per Week
timeFrame: Week 0
measure: Participant Education
timeFrame: Week 0
measure: Participant Income
timeFrame: Week 0
measure: Racial Diversity
timeFrame: Week 0
measure: Sexual Diversity
timeFrame: Week 0
measure: Immigration Status
timeFrame: Week 0
measure: Adherence
timeFrame: Week 1-9
measure: Acceptability
timeFrame: Week 10
measure: Uptake
timeFrame: Week 5-22
measure: Retention
timeFrame: Week 22
Secondary outcomes:
measure: Couples' Relationship Quality
timeFrame: Week 0-22
measure: Conflict Frequency
timeFrame: Week 0-22
measure: Conflict-Related Negativity
timeFrame: Week 1-9
measure: Coparenting
timeFrame: Week 0-22
measure: Brief Coparenting Assessment
timeFrame: Week 1-9
measure: Parent-Child Positivity
timeFrame: Week 0-22
measure: Parent-Child Negativity
timeFrame: Week 0-22
measure: Parent Mental Health
timeFrame: Week 0-22
measure: Perceived Partner Responsiveness
timeFrame: Week 0-22
measure: Responsiveness Towards Partner
timeFrame: Week 0-22
measure: Family Functioning
timeFrame: Week 0-22
measure: Child Emotional and Behavioural Problems
timeFrame: Week 0-22
measure: Child Effortful Control
timeFrame: Week 0-22
measure: Child Development
timeFrame: Week 0-22
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: