| Literature DB >> 35933434 |
Heather Prime1, Amy Muise2, Veronica Benyamin2, Lehana Thabane3,4,5, Mark Wade6.
Abstract
BACKGROUND: The COVID-19 pandemic has introduced or amplified stress and challenge within couples' relationships. Among those who are particularly vulnerable to heightened conflict and lower relationship satisfaction during this time are interparental couples with young children, whose relationships may have already been tenuous prior to the pandemic. Stress within the interparental relationship may have ripple effects on all family subsystems and child adjustment. The Love Together Parent Together (L2P2) program is a brief, low-intensity writing intervention adapted for parents of young children that was designed to reduce conflict-related distress and prevent declines in relationship satisfaction. Based on an original writing intervention by Finkel and colleagues, L2P2 has adapted the intervention duration and study population to be appropriate to the current global context. This study will examine the key feasibility metrics related to this adapted program with the goal of identifying problems and informing parameters of future pilot and/or main RCTs.Entities:
Keywords: Family systems; Interparental conflict; Single-arm feasibility study; Writing intervention
Year: 2022 PMID: 35933434 PMCID: PMC9356452 DOI: 10.1186/s40814-022-01115-y
Source DB: PubMed Journal: Pilot Feasibility Stud ISSN: 2055-5784
Schedule of enrollment, intervention, and assessments
| Study period | ||||||
|---|---|---|---|---|---|---|
| Enrollment | Post-enrollment | |||||
| Time point | ||||||
| Enrollment | ||||||
| Eligibility screen | X | |||||
| Informed consent | X | |||||
| | X | |||||
| Allocation | ||||||
| Interventions | ||||||
| | X | X | X | |||
| Assessments | ||||||
| | X | |||||
| | X | X | ||||
| | X | X | X | |||
| | X | X | ||||
| | X | |||||
Study objectives with associated outcomes and criteria for success of feasibility, hypothesis for secondary outcomes, and methods of analyses
| Outcome | Criteria for “success” of feasibility/hypothesis | Method of analysis | |
|---|---|---|---|
| Primary objectives to determine: | |||
| Recruitment | Number of participants | 10 couples per week over the course of 4 weeks who access our registration site. | Descriptive statistics |
| Number of participants | 5 couples per week over the course of 4 weeks who enroll in the study. | ||
| Eligibility criteria | % interested participants that meet the | < 50% of participants are excluded for any one criterion. | |
| Sample diversity | % participants income ≤ regional median, ≤ high school degree | > 30% of our sample has 1+ indicator. | |
| Sample diversity (race/ethnicity/immigration) | % participants racialized, immigrant | > 30% of our sample has 1+ indicator. | |
| Sample diversity (sexual orientation/gender) | % participants non-heterosexual, gender non-conforming | > 30% of our sample has 1+ indicator. | |
| Mild-moderate risk for relationship distress | % participants scoring ‘clinically distressed’ (<12) on the Brief Dyadic Adjustment Scale [ % participants scoring “high” (> 29) on the | < 50% of eligible participants. | |
| Participant retention | % participants who remain in study until end of post-intervention assessment | > 90% of participants. | |
| Participant adherence | % participants who complete 2/3 intervention sessions | > 90% of participants. | |
| Participant uptake | % participants reporting some use of conflict reappraisal outside of sessions | > 80% of participants. | |
| Acceptability | % of participants reporting at least “good” on 80% or more indicators on an | > 80% of participants, (stratified by gender, immigrant status, and racialized groups). | |
| Primary outcome measure development | Objective assessment of we-ness [ | Inter-rater reliability (Cronbach’s alpha > .80). Internal consistency (Cronbach’s alpha > .70). Significant group differences between male and female participants based on Significant correlations ( | |
| Secondary objective to explore: | |||
| Pre-post change in outcome measures | Intervention will improve outcomes from baseline to post-intervention surveys. | 3-level multilevel models, similar to regression analysis but accounting for clustering within the data structure | |