Love Together, Parent Together: A Feasibility Study

Internet-Based Intervention Clinical Trial

— L2P2  

Official title:

Love Together, Parent Together (L2P2): A Feasibility Study of an Ultra-brief Couples Conflict Program for Parents of Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143437
• Other study ID #: e2021-266
• Status: Completed
• Phase: N/A
• Start date: August 26, 2021
• Est. completion date: November 14, 2021

Study information

• Verified date: November 2021
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The COVID-19 pandemic has introduced additional stressors and challenges to couples' relationships, with potential ripple effects across all family subsystems and child adjustment. Among those who are particularly vulnerable to heightened conflict and lower relationship satisfaction during this time are couples with young children, whose relationships may have already been tenuous prior to the pandemic. The Love Together Parent Together (L2P2) program is a brief, low-intensity writing intervention adapted for parents of young children, designed to reduce conflict-related distress and prevent relationship deterioration. Based on an original writing program by Finkel and colleagues, adaptations include intervention duration and study population. The current study will examine key feasibility metrics related to this adapted intervention program with the goal of identifying problems and informing parameters of future pilot and/or main randomized controlled trials (RCT). The current study is a non-randomised feasibility study, using a single-arm, pre-test/post-test design to primarily assess the feasibility of a large trial, and secondarily to assess the potential effects on outcomes to be used in a future RCT. Couples will be recruited through three community-based agencies with the goal of obtaining a socio-demographically diverse sample. The first 20 couples to enroll will be included. Baseline and post-intervention surveys will be conducted, and a writing intervention will take place (three 7-minute sessions over the course of four weeks). The primary feasibility metrics will include recruitment rates, appropriateness of eligibility criteria, sample diversity, retention, uptake, and adherence, and acceptability. In addition, the researchers will develop an objective primary outcome measure of couple "we-ness" based on analysis of writing samples. The secondary outcomes will include couples' measures (i.e., relationship quality, perceived partner responsiveness, self-reported partner responsiveness, conflict-related distress), and other family outcomes (i.e., parent-child relations, parental/child mental health, and parenting practices). Criteria for success are outlined and failure to meet criteria will result in adaptations to measurement schedule, intervention design, recruitment approaches, and/or other elements of the study design. This feasibility study will inform several components of the procedures used for a subsequent pilot RCT, which will examine the feasibility of the methodology used to evaluate the program (e.g., randomization, attrition to follow up assessment/across groups, and sample size estimation, preliminary effectiveness), and a main trial, which will investigate the effectiveness of the intervention on primary outcome measures as well as mediating pathways.

Description:

See attached protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 14, 2021
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Family Conflict
• Internet-Based Intervention

Intervention

Behavioral:
• Love Together Parent Together
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.

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
York University	McMaster University, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Accessed Per Week	Number of participants accessed (I.e., initiate registration) per week, stratified by recruitment source.	Week 0
Primary	Couple "we-ness"	Assessing couple "we-ness" using a content analysis of writing samples collected during the intervention.	Week 1-5
Primary	Appropriateness of Eligibility Criteria	Percentage of interested participants that meet inclusion criteria (with reasons for exclusion).	Week 0
Primary	Participant Income	The percentage of participants income that is less than or equal to the regional median.	Week 0
Primary	Retention	The percentage of participants who remain in study until the end of the post-intervention assessment.	Week 6
Primary	Uptake	The percentage of participants reporting some use of conflict reappraisal outside of sessions.	Week 3-5
Primary	Adherence	The percentage of participants who complete 2/3 intervention sessions.	Week 1-5
Primary	Acceptability	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
Primary	Participants Enrolled Per Week	Number of participants enrolled per week, stratified by recruitment source.	Week 0
Primary	Participant Education	The percentage of participants with less than or equal to a high school degree.	Week 0
Primary	Racial Diversity	The percentage of participants who are a racial minority.	Week 0
Primary	Immigrant Status	The percentage of participants who are an immigrant.	Week 0
Primary	Sexual Diversity	The percentage of participants who are gender and/or sexually diverse.	Week 0
Primary	Risk for Relationship Distress - Dyadic Adjustment	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
Primary	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
Secondary	Pre-Post Change in Parent Mental Health	Using the Kessler Psychological Distress Scale. Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.	Pre-post change from week 0 to week 6.
Secondary	Pre-Post Change in Parent-Child Relations	Using the Parenting Practices Scale from the Ontario Child Health Study. Minimum score=11, maximum score=55. Higher scores correspond to better outcomes.	Pre-post change from week 0 to week 6.
Secondary	Pre-Post Change in Couples' Relationship Quality	Using the Perceived Relationship Quality Scale. Minimum score= 18, maximum score=126. Higher scores correspond to better outcomes.	Pre-post change from week 0 to week 6.
Secondary	Pre-Post Change in Conflict-Related Negativity	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.	Pre-post change from week 0 to week 6.
Secondary	Pre-Post Change in 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.	Pre-post change from week 0 to week 6.
Secondary	Pre-Post Change in 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 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.
Secondary	Pre-Post Change in 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.	Pre-post change from week 0 to week 6.