- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05143437
Love Together, Parent Together: A Feasibility Study (L2P2)
Love Together, Parent Together (L2P2): A Feasibility Study of an Ultra-brief Couples Conflict Program for Parents of Young Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
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 home
- 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 as this is meant to be a secondary preventative intervention for couples experiencing some but not severe relationship difficulties.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Writing Intervention
Couples will take part in three 7-minute online writing sessions over the course of four weeks.
|
A brief, low-intensity writing intervention adapted for parents of young children, designed to reduce conflict-related distress, prevent relationship deterioration and encourage the use of conflict reappraisal strategies designed to reduce conflict-related distress, etc.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
Participants Enrolled Per Week
Time Frame: Week 0
|
Number of participants enrolled per week, stratified by recruitment source.
|
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
|
|
Sexual Diversity
Time Frame: Week 0
|
The percentage of participants who are gender and/or sexually diverse.
|
Week 0
|
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Participants Accessed Per Week
Time Frame: Week 0
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Number of participants accessed (I.e., initiate registration) per week, stratified by recruitment source.
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Week 0
|
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Couple "we-ness"
Time Frame: Week 1-5
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Assessing couple "we-ness" using a content analysis of writing samples collected during the intervention.
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Week 1-5
|
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Appropriateness of Eligibility Criteria
Time Frame: Week 0
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Percentage of interested participants that meet inclusion criteria (with reasons for exclusion).
|
Week 0
|
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Retention
Time Frame: Week 6
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The percentage of participants who remain in study until the end of the post-intervention assessment.
|
Week 6
|
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Uptake
Time Frame: Week 3-5
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The percentage of participants reporting some use of conflict reappraisal outside of sessions.
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Week 3-5
|
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Adherence
Time Frame: Week 1-5
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The percentage of participants who complete 2/3 intervention sessions.
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Week 1-5
|
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Acceptability
Time Frame: Week 6
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Looking for the percentage of participants reporting at least 'good' on 80 % or more indicators on an Implementation Acceptability Scale that will assess attitude, burden, perceived effectiveness, and ethicality.
Minimum score=7, maximum score=35.
Higher scores correspond to better outcomes.
|
Week 6
|
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Participant Education
Time Frame: Week 0
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The percentage of participants with less than or equal to a high school degree.
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Week 0
|
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Racial Diversity
Time Frame: Week 0
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The percentage of participants who are a racial minority.
|
Week 0
|
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Immigrant Status
Time Frame: Week 0
|
The percentage of participants who are an immigrant.
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Week 0
|
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Risk for Relationship Distress - Dyadic Adjustment
Time Frame: Week 0
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The percentage of participants scoring in the 'clinical' range (>13) on the Dyadic Adjustment Scale.
Minimum score=1, maximum score=22.
Higher scores correspond to worse outcomes.
|
Week 0
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-Post Change in Parent Mental Health
Time Frame: Pre-post change from week 0 to week 6.
|
Using the Kessler Psychological Distress Scale.
Minimum score=10, maximum score=50.
Higher scores correspond to worse outcomes.
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Pre-post change from week 0 to week 6.
|
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Pre-Post Change in Parent-Child Relations
Time Frame: Pre-post change from week 0 to week 6.
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Using the Parenting Practices Scale from the Ontario Child Health Study.
Minimum score=11, maximum score=55.
Higher scores correspond to better outcomes.
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Pre-post change from week 0 to week 6.
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Pre-Post Change in Couples' Relationship Quality
Time Frame: Pre-post change from week 0 to week 6.
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Using the Perceived Relationship Quality Scale.
Minimum score= 18, maximum score=126.
Higher scores correspond to better outcomes.
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Pre-post change from week 0 to week 6.
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Pre-Post Change in Conflict-Related Negativity
Time Frame: Pre-post change from week 0 to week 6.
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Using two items following 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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Pre-post change from week 0 to week 6.
|
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Pre-Post Change in Perceived Partner Responsiveness
Time Frame: Pre-post change from week 0 to week 6.
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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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Pre-post change from week 0 to week 6.
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Pre-Post Change in Child Emotional and Behavioural Problems
Time Frame: Pre-post change from week 0 to week 6.
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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 Symptom 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. |
Pre-post change from week 0 to week 6.
|
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Pre-Post Change in Responsiveness Towards Partner
Time Frame: Pre-post change from week 0 to week 6.
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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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Pre-post change from week 0 to week 6.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather Prime, PhD, York University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- e2021-266
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
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