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临床试验/NCT05143437
NCT05143437已完成不适用

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

York University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Racial Diversity

研究概览

简要总结

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.

详细描述

See attached protocol.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Racial Diversity

时间窗: Week 0

The percentage of participants who are a racial minority.

Participant Income

时间窗: Week 0

The percentage of participants income that is less than or equal to the regional median.

Participants Accessed Per Week

时间窗: Week 0

Number of participants accessed (I.e., initiate registration) per week, stratified by recruitment source.

Retention

时间窗: Week 6

The percentage of participants who remain in study until the end of the post-intervention assessment.

Uptake

时间窗: Week 3-5

The percentage of participants reporting some use of conflict reappraisal outside of sessions.

Participants Enrolled Per Week

时间窗: Week 0

Number of participants enrolled per week, stratified by recruitment source.

Risk for Relationship Distress - COVID-19 Family Stressors

时间窗: 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.

Acceptability

时间窗: Week 6

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.

Risk for Relationship Distress - Dyadic Adjustment

时间窗: Week 0

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.

Couple "we-ness"

时间窗: Week 1-5

Assessing couple "we-ness" using a content analysis of writing samples collected during the intervention.

Appropriateness of Eligibility Criteria

时间窗: Week 0

Percentage of interested participants that meet inclusion criteria (with reasons for exclusion).

Immigrant Status

时间窗: Week 0

The percentage of participants who are an immigrant.

Sexual Diversity

时间窗: Week 0

The percentage of participants who are gender and/or sexually diverse.

Adherence

时间窗: Week 1-5

The percentage of participants who complete 2/3 intervention sessions.

Participant Education

时间窗: Week 0

The percentage of participants with less than or equal to a high school degree.

次要结局

  • Pre-Post Change in Responsiveness Towards Partner(Pre-post change from week 0 to week 6.)
  • Pre-Post Change in Conflict-Related Negativity(Pre-post change from week 0 to week 6.)
  • Pre-Post Change in Parent Mental Health(Pre-post change from week 0 to week 6.)
  • Pre-Post Change in Parent-Child Relations(Pre-post change from week 0 to week 6.)
  • Pre-Post Change in Perceived Partner Responsiveness(Pre-post change from week 0 to week 6.)
  • Pre-Post Change in Child Emotional and Behavioural Problems(Pre-post change from week 0 to week 6.)
  • Pre-Post Change in Couples' Relationship Quality(Pre-post change from week 0 to week 6.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Prime

Assistant Professor

York University

研究点 (2)

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Love Together, Parent Together: A Feasibility Study | 临床试验