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Interparental ConflictL2P2NCT05261022

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

A study testing Love Together, Parent Together (L2P2) in people with Interparental Conflict and Marital Conflict, run by York University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Love Together, Parent Together (L2P2)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteCanada
Study dates
1 Apr 2022to Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • No current plans or history of separation or divorce

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • York University

    Toronto, Ontario, M3J 1P3

Other trials in Canada

About this study

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

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.

Being tested
Love Together, Parent Together (L2P2)
Keywords
Online Intervention, Family Systems, Randomized Controlled Trial, Writing Intervention, Couples' relationships

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Love Together, Parent Together (L2P2)Behavioural

    Also called L2P2

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

Study groups in NCT05261022
Study groupRoleWhat they receive
Love Together, Parent Together InterventionExperimentalParticipants 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.
Receives: Behavioral: Love Together, Parent Together (L2P2)
Wait-List Control GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 0-22

  2. 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.

    Measured: Week 0

  3. COVID Coping/Benefits

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

    Measured: Week 0

  4. Adverse Childhood Experiences

    Background information. Adverse Childhood Experiences Scale. Minimum score=0, maximum score=14. Higher scores correspond to higher ACES count.

    Measured: Week 0

  5. Participants Enrolled Per Week

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

    Measured: Week 0

  6. Participant Education

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

    Measured: Week 0

  7. Participant Income

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

    Measured: Week 0

  8. Racial Diversity

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

    Measured: Week 0

  9. Sexual Diversity

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

    Measured: Week 0

  10. Immigration Status

    The percentage of participants who were born outside of Canada.

    Measured: Week 0

  11. Adherence

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

    Measured: Week 1-9

  12. 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.

    Measured: Week 10

  13. 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.

    Measured: Week 5-22

  14. 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).

    Measured: Week 22

Secondary outcomes (14)
  1. Couples' Relationship Quality

    Using the Perceived Relationship Quality Scale. Minimum score=18, maximum score=126. Higher scores correspond to better outcomes.

    Measured: Week 0-22

  2. Conflict Frequency

    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.

    Measured: Week 0-22

  3. Conflict-Related Negativity

    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.

    Measured: Week 1-9

  4. Coparenting

    The Brief Coparenting Relationship Scale. Minimum score=0, maximum score=84. Higher scores correspond to better outcomes.

    Measured: Week 0-22

  5. Brief Coparenting Assessment

    Six items from the Brief Coparenting Relationship Scale (Feinberg et al., 2012). Minimum score = 0, maximum score = 36. Higher scores correspond to better outcomes.

    Measured: Week 1-9

  6. Parent-Child Positivity

    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.

    Measured: Week 0-22

  7. Parent-Child Negativity

    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.

    Measured: Week 0-22

  8. Parent Mental Health

    Using the Kessler Psychological Distress Scale. Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.

    Measured: Week 0-22

  9. Perceived Partner Responsiveness

    Using the Perceived Partner Responsiveness-Insensitivity Scale (PRI-R)- Brief Version. Minimum score=8, maximum score=40. Higher scores correspond to better outcomes.

    Measured: Week 0-22

  10. Responsiveness Towards Partner

    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.

    Measured: Week 0-22

  11. Family Functioning

    Using the Family Assessment Device. Minimum score=12, maximum score=48. Higher scores correspond to worse outcomes.

    Measured: Week 0-22

  12. Child Emotional and Behavioural Problems

    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.

    Measured: Week 0-22

  13. Child Effortful Control

    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.

    Measured: Week 0-22

  14. Child Development

    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.

    Measured: Week 0-22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completionJan 2023 (estimated)
  4. Study completionJan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Investigator
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05261022
Sponsor's protocol ID
e2022-267
Acronym
L2P2
Status last verified
Jan 2023
First submitted
18 Feb 2022
Last updated
20 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Love Together, Parent Together (L2P2) in people with Interparental Conflict and Marital Conflict, run by York University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk for Relationship Distress - Dyadic Adjustment Scale (time frame: Week 0-22). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.

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