Clinical Trials Logo

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.


Clinical Trial Description

See attached protocol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05143437
Study type Interventional
Source York University
Contact
Status Completed
Phase N/A
Start date August 26, 2021
Completion date November 14, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06012084 - The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis N/A
Completed NCT04775927 - Pre-marital Internet-based Sexual and Reproductive Health Education N/A
Completed NCT04544930 - Therapist-guided Internet Treatment for Hazardous and Harmful Alcohol Use. A Feasibility Study N/A
Completed NCT05895539 - Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool N/A
Completed NCT04650906 - A Feasibility Study for Evaluating the Effectiveness of Mindhelper - a National Youth Mental Health Promotion Website N/A
Completed NCT04688567 - Patient-driven Internet Delivered Psychological Treatment N/A
Not yet recruiting NCT04409210 - Cardio-Cerebrovascular Co-Prevention and Co-Management Based on Internet+ N/A
Withdrawn NCT05442762 - Social Media-based Vaccine Confidence and Hesitancy Monitoring
Completed NCT04902404 - Evaluation of the First Pathways Game on Parent-child Interactions and Development for Vulnerable Children N/A
Recruiting NCT05356247 - Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting N/A
Completed NCT02835768 - Effectiveness of Internet-based Injury Prevention Program in Enhancing Mother's Knowledge on Child Safety N/A
Completed NCT05777915 - SOSteniamoci: Usability Study
Not yet recruiting NCT06020274 - Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work? N/A
Completed NCT04259268 - Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application
Recruiting NCT05281913 - Psychoeducational Simulation Game for Adults in Stepfamilies N/A
Recruiting NCT05711342 - The Added Value of an Internet-based Intervention for Treatment of Forensic Psychiatric Outpatients N/A
Completed NCT05235243 - Can Mindfulness and Self-monitoring Improve Control Over Maladaptive Daydreaming? N/A
Not yet recruiting NCT06385457 - The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking N/A
Recruiting NCT04787783 - Evaluation of the Utility of Preanestes@s, a Web Based Application for Preoperative Assessment N/A
Active, not recruiting NCT05261022 - Love Together, Parent Together: A Protocol for a Pilot Study of an Intervention for Interparental Couples With Young Children N/A