Love Together, Parent Together: A Protocol for a Pilot Study of an Intervention for Interparental Couples With Young Children

Internet-Based Intervention Clinical Trial

— L2P2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05261022
• Other study ID #: e2022-267
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 2023

Study information

• Verified date: January 2023
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• 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 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

Exclusion Criteria:

• No current plans or history of separation or divorce

Related Conditions & MeSH terms

• Family Conflict
• Internet-Based Intervention
• Interparental Conflict
• Marital Conflict
• Marital Relationship

Intervention

Behavioral:
• Love Together, Parent Together (L2P2)
Love Together Parent Together (L2P2) is a brief, low-intensity relationship intervention intended to improve the interparental relationship for parents of young children.

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	Risk for Relationship Distress - Dyadic Adjustment Scale	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.	Week 0-22
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
Primary	COVID Coping/Benefits	Background information. Minimum score=14, maximum score=42 . Higher scores correspond to better outcomes.	Week 0
Primary	Adverse Childhood Experiences	Background information. Adverse Childhood Experiences Scale. Minimum score=0, maximum score=14. Higher scores correspond to higher ACES count.	Week 0
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 College degree.	Week 0
Primary	Participant Income	The percentage of participants income that is less than or equal to the regional median.	Week 0
Primary	Racial Diversity	The percentage of participants who identify as part of a racialized group.	Week 0
Primary	Sexual Diversity	The percentage of participants who are gender and/or sexually diverse.	Week 0
Primary	Immigration Status	The percentage of participants who were born outside of Canada.	Week 0
Primary	Adherence	The percentage of participants who complete 2/3 intervention sessions.	Week 1-9
Primary	Acceptability	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.	Week 10
Primary	Uptake	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.	Week 5-22
Primary	Retention	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).	Week 22
Secondary	Couples' Relationship Quality	Using the Perceived Relationship Quality Scale. Minimum score=18, maximum score=126. Higher scores correspond to better outcomes.	Week 0-22
Secondary	Conflict Frequency	Using one item on a 7-point Likert scale: "Think about your experiences with your partner over the last four weeks. How often did you and your partner argue with each other?" Minimum score=1, maximum score=7. Higher scores correspond to worse outcomes.	Week 0-22
Secondary	Conflict-Related Negativity	Using two items following a 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.	Week 1-9
Secondary	Coparenting	The Brief Coparenting Relationship Scale. Minimum score=0, maximum score=84. Higher scores correspond to better outcomes.	Week 0-22
Secondary	Brief Coparenting Assessment	Six items from the Brief Coparenting Relationship Scale (Feinberg et al., 2012). Minimum score = 0, maximum score = 36. Higher scores correspond to better outcomes.	Week 1-9
Secondary	Parent-Child Positivity	Using the 5-item parent-reported positivity subscale of the Parenting Practices Scale. Minimum score=5, maximum score=25. Higher scores correspond to better outcomes.	Week 0-22
Secondary	Parent-Child Negativity	Using the 5-item parent-reported negativity subscale of the Parenting Practices Scale. Minimum score=5, maximum score=25. Higher scores correspond to worse outcomes.	Week 0-22
Secondary	Parent Mental Health	Using the Kessler Psychological Distress Scale. Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.	Week 0-22
Secondary	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.	Week 0-22
Secondary	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.	Week 0-22
Secondary	Family Functioning	Using the Family Assessment Device. Minimum score=12, maximum score=48. Higher scores correspond to worse outcomes.	Week 0-22
Secondary	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 Symptoms 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.	Week 0-22
Secondary	Child Effortful Control	Using the Effortful Control subscale (12 items) of the Infant Behaviour Questionnaire- Revised Very Short Form (3-12 months), Early Childhood Behavior Questionnaire-Revised Very Short Form (18-36 months) and Children's Behaviour Questionnaire-Revised Very Short Form (3-7 years). Minimum score=0 , maximum score=84. Higher scores correspond to better outcomes.	Week 0-22
Secondary	Child Development	Using the 10-item Developmental Milestones scale from The Survey of Well-being of Young Children (i.e., the 2, 4, 6, 9, 12, 15, 18, 24, 30, 36, 48 and 60 month age-specific forms). Minimum score=0, maximum score =20. Higher scores correspond to better outcomes.	Week 0-22