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
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
- 是
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
Heather Prime
Assistant Professor
York University
