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临床试验/NCT05261022
NCT05261022进行中(未招募)不适用

Love Together, Parent Together (L2P2): A Protocol for a Pilot RCT of a Brief Writing Intervention for Interparental Couples With Young Children Amid the COVID-19 Pandemic

York University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
240
试验地点
2
主要终点
Retention

研究概览

简要总结

The COVID-19 pandemic has created a population-level threat to social relationships that requires a population-level solution. Among those who are particularly vulnerable to heightened conflict are interparental couples with young children, whose relationships may have already been under pressure prior to the pandemic. Reduced couples' satisfaction has been reported since the start of the pandemic, with over one-third of romantic partners reporting heightened conflict due to COVID-19. Couples are likely to stay in disharmonious relationships during times of socioeconomic upheaval, with the potential for relationship problems to persist over time. This may have serious implications for the mental health of parents, parent-child relationships, and children's emotional and behavioural problems (EBPs). Such a pattern is a societal concern given the known associations between couples' relationship quality and a number of critical indicators of population health, such as intimate partner violence, physical health and all-cause mortality, and economic instability, particularly for women. The current study protocol is for a pilot randomized controlled trial (RCT) of the Love Together Parent Together (L2P2) program-a brief, low-intensity, scalable relationship intervention for parents of young children. The two-arm (treatment vs. waitlist) pilot RCT will assess the feasibility goals: continued relationship-building with established recruitment partners and outreach to additional recruitment partners to increase enrolment rates; recruitment of a diverse sample in terms of sociocultural identity factors, pandemic-related stress, and relationship distress; acceptability of randomization; outcome assessment schedule completion (for treatment and control groups), retention and adherence to the program; and program acceptability. Additionally, the investigators will conduct a preliminary evaluation of treatment effects by examining group differences in couples-focused (i.e., couples' relationship, conflict-related negativity, interparental functioning) and family-focused outcomes (i.e., parent-child relations, parent mental health and child outcomes). A scalable couples-focused intervention is critically needed to circumvent the social consequences of the pandemic on young families.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

Participants will be unmasked to their group assignment as they will be told their group assignment, by virtue of the psychosocial intervention. There is no care provider (the intervention is participant-directed and fully online). Participants report on their own outcomes and thus outcomes are not masked. Feasibility outcomes are masked. Study team investigators, including data analysts, will be masked. The research coordinator will be the only unmasked member of the research team.

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 house
  • 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

结局指标

主要结局

Retention

时间窗: Week 22

The percentage of participants who complete their Randomly Allocated Assignment (defined as completing baseline, 2/3 writing sessions, post-intervention, and 1/2 follow-up surveys).

Racial Diversity

时间窗: Week 0

The percentage of participants who identify as part of a racialized group.

Risk for Relationship Distress - Dyadic Adjustment Scale

时间窗: Week 0-22

The percentage of participants scoring in the 'clinical range' (\<13) on the Dyadic Adjustment Scale. Minimum score=1, maximum score=22. Lower scores correspond to worse outcomes.

Participant Education

时间窗: Week 0

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

Participant Income

时间窗: Week 0

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

Sexual Diversity

时间窗: Week 0

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

Immigration Status

时间窗: Week 0

The percentage of participants who were born outside of Canada.

Adherence

时间窗: Week 1-9

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

COVID Coping/Benefits

时间窗: Week 0

Background information. Minimum score=14, maximum score=42 . Higher scores correspond to better outcomes.

Uptake

时间窗: Week 5-22

The percentage of participants reporting some use of conflict reappraisal outside of intervention sessions (i.e., reporting a score of 3 or more on a scale of 1-7). Minimum score=1, maximum score=7. Higher scores correspond to better outcomes.

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.

Adverse Childhood Experiences

时间窗: Week 0

Background information. Adverse Childhood Experiences Scale. Minimum score=0, maximum score=14. Higher scores correspond to higher ACES count.

Participants Enrolled Per Week

时间窗: Week 0

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

Acceptability

时间窗: Week 10

The percentage of participants reporting at least 'agree' on scales of attitude, burden, perceived effectiveness, and ethicality on the Implementation Acceptability Scale. Minimum score=7, maximum score=35. Higher scores correspond to higher acceptability.

次要结局

  • Conflict Frequency(Week 0-22)
  • Parent-Child Negativity(Week 0-22)
  • Child Emotional and Behavioural Problems(Week 0-22)
  • Perceived Partner Responsiveness(Week 0-22)
  • Responsiveness Towards Partner(Week 0-22)
  • Brief Coparenting Assessment(Week 1-9)
  • Parent-Child Positivity(Week 0-22)
  • Family Functioning(Week 0-22)
  • Couples' Relationship Quality(Week 0-22)
  • Conflict-Related Negativity(Week 1-9)
  • Coparenting(Week 0-22)
  • Parent Mental Health(Week 0-22)
  • Child Effortful Control(Week 0-22)
  • Child Development(Week 0-22)

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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