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Table 2 Study objectives with associated outcomes and criteria for success of feasibility, hypothesis for secondary outcomes, and methods of analyses

From: Love Together, Parent Together (L2P2): a protocol for a feasibility study of a conflict reappraisal writing intervention for interparental couples with young children

 

Outcome

Criteria for “success” of feasibility/hypothesis

Method of analysis

Primary objectives to determine:

 Recruitment

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

10 couples per week over the course of 4 weeks who access our registration site.

Descriptive statistics

Number of participants enrolled per week, stratified by recruitment source

5 couples per week over the course of 4 weeks who enroll in the study.

 Eligibility criteria

% interested participants that meet the inclusion criteria (with reasons for exclusion)

< 50% of participants are excluded for any one criterion.

 Sample diversity

% participants income ≤ regional median, ≤ high school degree

> 30% of our sample has 1+ indicator.

 Sample diversity (race/ethnicity/immigration)

% participants racialized, immigrant

> 30% of our sample has 1+ indicator.

 Sample diversity (sexual orientation/gender)

% participants non-heterosexual, gender non-conforming

> 30% of our sample has 1+ indicator.

 Mild-moderate risk for relationship distress

% participants scoring ‘clinically distressed’ (<12) on the Brief Dyadic Adjustment Scale [23]

% participants scoring “high” (> 29) on the COVID-19 Family Stressor Scale [24]

< 50% of eligible participants.

 Participant retention

% participants who remain in study until end of post-intervention assessment

> 90% of participants.

 Participant adherence

% participants who complete 2/3 intervention sessions

> 90% of participants.

 Participant uptake

% participants reporting some use of conflict reappraisal outside of sessions

> 80% of participants.

 Acceptability

% of participants reporting at least “good” on 80% or more indicators on an Implementation Acceptability Scale assessing attitude, burden, perceived effectiveness, and ethicality [25]

> 80% of participants, (stratified by gender, immigrant status, and racialized groups).

 Primary outcome measure development

Objective assessment of we-ness [19] based on content analysis of writing samples. Will include an analysis of first-person plural pronouns (we, us, our, ours), reference to partners’ internal states (beliefs, desires, intentions), and positive affective language [26]

Inter-rater reliability (Cronbach’s alpha > .80).

Internal consistency (Cronbach’s alpha > .70).

Significant group differences between male and female participants based on t-tests (p < .05).

Significant correlations (p < .05) with indices of convergent validity (i.e., self-reported responsiveness, partner reported perceived partner responsiveness).

Secondary objective to explore:

 Pre-post change in outcome measures

Couples’ relationship quality: Perceived Relationship Quality Components(PRQC) Inventory [27].

Intervention will improve outcomes from baseline to post-intervention surveys.

3-level multilevel models, similar to regression analysis but accounting for clustering within the data structure

Conflict-related negativity: two items following fact-based summary: “I was angry at my partner for his/her behavior during this conflict,” “My partner’s behavior during this conflict was highly upsetting to me” [14].

Perceived partner responsiveness/responsiveness directed towards partner: two eight-item scales will assess participants’ perceptions of their partners’ responsiveness/insensitivity and their own responsiveness/insensitivity towards their partner, respectively [28].

Parent-child relations, Parenting Practices Scale from the Ontario Child Health Study [29].

Parent Mental Health, K10 Psychological Distress Scale [30].

Child emotional and behavioral problems, Pediatric Symptom Checklist (baby, preschool, and standard versions) [31].