Family ConflictL2P2NCT05143437
Love Together, Parent Together: A Feasibility Study
A study testing Love Together Parent Together in people with Family Conflict and Internet-Based Intervention, run by York University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Conflict, Internet-Based Intervention
- What is being tested?
- Love Together Parent Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2021to 14 Nov 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Love Together, Parent Together (L2P2): A Feasibility Study of an Ultra-brief Couples Conflict Program for Parents of Young Children
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.
Read the detailed description
See attached protocol.
- Conditions
- Family Conflict, Internet-Based Intervention
- Being tested
- Love Together Parent Together
- Keywords
- Couples' relationships, Family Systems, Writing Intervention, Non-randomised, Feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Love Together Parent TogetherBehavioural
Also called L2P2
A brief, low-intensity writing intervention adapted for parents of young children, designed to reduce conflict-related distress, prevent relationship deterioration and encourage the use of conflict reappraisal strategies designed to reduce conflict-related distress, etc.
| Study group | Role | What they receive |
|---|---|---|
| Writing Intervention | Experimental | Couples will take part in three 7-minute online writing sessions over the course of four weeks. Receives: Behavioral: Love Together Parent Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Accessed Per Week
Number of participants accessed (I.e., initiate registration) per week, stratified by recruitment source.
Measured: Week 0
Couple "we-ness"
Assessing couple "we-ness" using a content analysis of writing samples collected during the intervention.
Measured: Week 1-5
Appropriateness of Eligibility Criteria
Percentage of interested participants that meet inclusion criteria (with reasons for exclusion).
Measured: Week 0
Participant Income
The percentage of participants income that is less than or equal to the regional median.
Measured: Week 0
Retention
The percentage of participants who remain in study until the end of the post-intervention assessment.
Measured: Week 6
Uptake
The percentage of participants reporting some use of conflict reappraisal outside of sessions.
Measured: Week 3-5
Adherence
The percentage of participants who complete 2/3 intervention sessions.
Measured: Week 1-5
Acceptability
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.
Measured: Week 6
Participants Enrolled Per Week
Number of participants enrolled per week, stratified by recruitment source.
Measured: Week 0
Participant Education
The percentage of participants with less than or equal to a high school degree.
Measured: Week 0
Racial Diversity
The percentage of participants who are a racial minority.
Measured: Week 0
Immigrant Status
The percentage of participants who are an immigrant.
Measured: Week 0
Sexual Diversity
The percentage of participants who are gender and/or sexually diverse.
Measured: Week 0
Risk for Relationship Distress - Dyadic Adjustment
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.
Measured: Week 0
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.
Measured: Week 0
Secondary outcomes (7)
Pre-Post Change in Parent Mental Health
Using the Kessler Psychological Distress Scale. Minimum score=10, maximum score=50. Higher scores correspond to worse outcomes.
Measured: Pre-post change from week 0 to week 6.
Pre-Post Change in Parent-Child Relations
Using the Parenting Practices Scale from the Ontario Child Health Study. Minimum score=11, maximum score=55. Higher scores correspond to better outcomes.
Measured: Pre-post change from week 0 to week 6.
Pre-Post Change in Couples' Relationship Quality
Using the Perceived Relationship Quality Scale. Minimum score= 18, maximum score=126. Higher scores correspond to better outcomes.
Measured: Pre-post change from week 0 to week 6.
Pre-Post Change in Conflict-Related Negativity
Using two items following 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.
Measured: Pre-post change from week 0 to week 6.
Pre-Post Change in 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.
Measured: Pre-post change from week 0 to week 6.
Pre-Post Change in 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 Symptom 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.
Measured: Pre-post change from week 0 to week 6.
Pre-Post Change in 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.
Measured: Pre-post change from week 0 to week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start26 Aug 2021
- Primary completion14 Nov 2021
- Study completion14 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family ConflictStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, McMaster University
- Responsible party
- Principal investigator, Heather Prime, York University
- Investigators
- Heather Prime, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143437
- Sponsor's protocol ID
- e2021-266
- Acronym
- L2P2
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prime H, Muise A, Benyamin V, Thabane L, Wade M. Love Together, Parent Together (L2P2): a protocol for a feasibility study of a conflict reappraisal writing intervention for interparental couples with young children. Pilot Feasibility Stud. 2022 Aug 6;8(1):170. doi: 10.1186/s40814-022-01115-y.
PubMed 35933434