- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05261022
Love Together, Parent Together: A Protocol for a Pilot Study of an Intervention for Interparental Couples With Young Children (L2P2)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M3J 1P3
- York University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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
|
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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.
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Week 0
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Participants Enrolled Per Week
Time Frame: Week 0
|
Number of participants enrolled per week, stratified by recruitment source.
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Week 0
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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
|
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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
|
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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.
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Week 10
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Uptake
Time Frame: Week 5-22
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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.
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Week 5-22
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Retention
Time Frame: Week 22
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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
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Conflict-Related Negativity
Time Frame: Week 1-9
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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.
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Week 1-9
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Coparenting
Time Frame: Week 0-22
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The Brief Coparenting Relationship Scale.
Minimum score=0, maximum score=84.
Higher scores correspond to better outcomes.
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Week 0-22
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Brief Coparenting Assessment
Time Frame: Week 1-9
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Six items from the Brief Coparenting Relationship Scale (Feinberg et al., 2012).
Minimum score = 0, maximum score = 36.
Higher scores correspond to better outcomes.
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Week 1-9
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Parent-Child Positivity
Time Frame: Week 0-22
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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.
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Week 0-22
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Parent-Child Negativity
Time Frame: Week 0-22
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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.
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Week 0-22
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Parent Mental Health
Time Frame: Week 0-22
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Using the Kessler Psychological Distress Scale.
Minimum score=10, maximum score=50.
Higher scores correspond to worse outcomes.
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Week 0-22
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Perceived Partner Responsiveness
Time Frame: Week 0-22
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Using the Perceived Partner Responsiveness-Insensitivity Scale (PRI-R)- Brief Version.
Minimum score=8, maximum score=40.
Higher scores correspond to better outcomes.
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Week 0-22
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Responsiveness Towards Partner
Time Frame: Week 0-22
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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.
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Week 0-22
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Family Functioning
Time Frame: Week 0-22
|
Using the Family Assessment Device.
Minimum score=12, maximum score=48.
Higher scores correspond to worse outcomes.
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Week 0-22
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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
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Child Effortful Control
Time Frame: Week 0-22
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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.
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Week 0-22
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Child Development
Time Frame: Week 0-22
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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
Sponsor
Investigators
- Principal Investigator: Heather Prime, PhD, York University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- e2022-267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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