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

NCT05261022 | Unknown

• 1 other identifier: e2022-267
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Interparental Conflict; Marital Conflict; Marital Relationship; Internet-Based Intervention; Family Conflict

Keywords

Online Intervention; Family Systems; Randomized Controlled Trial; Writing Intervention; Couples' relationships

Outcome Measures

Primary Outcomes (14)

• Risk for Relationship Distress - Dyadic Adjustment Scale

  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

  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

  Background information. Minimum score=14, maximum score=42 . Higher scores correspond to better outcomes.

  Week 0

• Adverse Childhood Experiences

  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

  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 College degree.

  Week 0

• Participant Income

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

  Week 0

• Racial Diversity

  The percentage of participants who identify as part of a racialized group.

  Week 0

• Sexual Diversity

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

  Week 0

• Immigration Status

  The percentage of participants who were born outside of Canada.

  Week 0

• Adherence

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

  Week 1-9

• Acceptability

  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

  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

  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 Outcomes (14)

• Couples' Relationship Quality

  Week 0-22

• Conflict Frequency

  Week 0-22

• Conflict-Related Negativity

  Week 1-9

• Coparenting

  Week 0-22

• Brief Coparenting Assessment

  Week 1-9

Study Arms (2)

Love Together, Parent Together Intervention

EXPERIMENTAL

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.

Behavioral: Love Together, Parent Together (L2P2)

Wait-List Control Group

NO INTERVENTION

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.

Interventions

Love Together, Parent Together (L2P2) BEHAVIORAL

Love Together Parent Together (L2P2) is a brief, low-intensity relationship intervention intended to improve the interparental relationship for parents of young children.

Also known as: L2P2

Love Together, Parent Together Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- No current plans or history of separation or divorce

Sponsors & Collaborators

• York University: lead
• University of Toronto: collaborator
• McMaster University: collaborator

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Study Officials

• Heather Prime, PhD

  York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be unmasked to their group assignment as they will be told their group assignment, by virtue of the psychosocial intervention. There is no care provider (the intervention is participant-directed and fully online). Participants report on their own outcomes and thus outcomes are not masked. Feasibility outcomes are masked. Study team investigators, including data analysts, will be masked. The research coordinator will be the only unmasked member of the research team.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: April 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

CA (1)