Family Check Up: The FCU is a brief, strengths-based and evidenced informed intervention designed to support positive parenting and child and family well-being. Phase 1 of FCU an initial interview, an assessment, and a feedback session. Motivation interviewing is incorporated into all three components. During the feedback session the providers and caregivers work together to create a list of resources based on the needs identified by the families. Providers will work to connect the families to the identified resources, so they are not left to navigate the complex systems alone. Additionally, families will then have the option of completing phase 2, Everyday Parenting. The EDP curriculum manual presents session outlines and materials organized into three skill areas: (1) supporting positive behavior, (2) setting healthy limits, and (3) building family relationships. The number of EDP sessions is flexible, enabling the clinician to tailor the EDP to unique family needs.
Study summary
Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all using a pilot pragmatic Hybrid Type II individually randomized controlled trial conducted within routine service settings. The trial will enroll 300 families in Ontario, Canada. The evaluation is informed by the RE-AIM framework, with a primary emphasis on Reach and Implementation and secondary examination of Effectiveness, consistent with the objectives of a Hybrid Type II design.
Eligibility
Sex
ALL
Min age
2 Years
Max age
6 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Custodial caregiver of child is aged 2 to 6 years at time of screening.
* Families with sufficient knowledge of English needed for assessment measures.
* Caregivers capable of giving informed, written consent.
* Definition of 'at-risk' as measured by (a) or (b)as outlined below:
parental mental health problems, as indexed by a score of ≥ 13 on the K6 distress scale or; (b) Meeting pre-determined criteria for higher risk, for example, a family may be eligible for FCU if any one or more of the following are present based on the Family Needs Assessment : i) child behaviour or school-related concerns; ii) parenting difficulty or low parenting confidence; iii) Substance use causing family-level problems; or iv) three or more social or material stressors affecting parenting
Exclusion Criteria:
* Families with in sufficient knowledge of English, Families with caregivers incapable of giving informed written consent
Primary outcome measure(s)
Recruitment Rate — During recruitment - pre-randomization Description: As part of the reach assessment of the RE-AIM domain, We will assess the extent to which the target population is reached in FCU. Recruitment will be assessed as the proportion of eligible families who consent and enroll in the study following screening for FCU+ eligibility.
Unit of Measure: Proportion (%) of eligible families enrolled. Recruitment will be interpreted using a traffic-light approach (green = feasible; amber = feasible with modification; red = not feasible without substantial redesign), which is commonly used in pilot trials to support transparent decision-making regarding progression.
Recruitment feasibility will be assessed based on the proportion of eligible families who consent and enroll:
* Green: ≥60% of eligible families approached enroll
* Amber: 40-59% enroll
* Red: \<40% enroll
Data Source: Study screening logs and REDCap enrollment records
Fidelity to FCU Delivery — During Intervention- on average 3-5 weeks Description: Fidelity to FCU delivery within routine services will be assessed for the core FCU components (initial interview, assessment, and feedback) using the COACH observational rating system. Sessions will be securely video-recorded and coded by trained raters.
Unit of Measure: Mean COACH fidelity score and proportion (%) of sessions meeting predefined fidelity thresholds. The COACH assesses five dimensions of observable in-session coordinator skills: conceptual accuracy; responsiveness to family context and needs; active session structuring; effective teaching and corrective feedback; and generation of hope and motivation. Each dimension includes exemplars and non-exemplars and is rated on a 9-point scale reflecting competent adherence to the program (1-3 = needs work; 4-6 = competent work; 7-9 = excellent work), with higher scores indicating stronger mastery of FCU principles
Data Source: Coded video-recorded sessions and fidelity rating forms
Retention — 3, 6, 9, and 12 months post-randomization Description: Retention will be assessed as the proportion of randomized participants who complete follow-up assessments at each scheduled time point.
Retention performance will be interpreted using a traffic-light approach (green = feasible; amber = feasible with modification; red = not feasible without substantial redesign). Retention feasibility will be assessed based on completion of follow-up assessments:
* Main follow-ups (6 and 12 months):
* Green: ≥80% retained at 6 months and ≥75% retained at 12 months
* Amber: 70-79% retained at 6 months and/or 65-74% retained at 12 months
* Red: \<70% retained at 6 months or \<65% retained at 12 months
* Short follow-ups (3 and 9 months):
* Green: ≥75% completion
* Amber: 65-74% completion
* Red: \<65% completion retained at 12 months:
* Green: ≥75% provide complete parenting and child outcome measures
* Amber: 65-74% complete data
* Red: \<65% complete data
Data Source: REDCap follow-up records
Completion of Core FCU Components — During Intervention - on average 3-5 weeks Description: Within the intervention arm, uptake of core FCU components will be assessed by completion of the assessment and feedback sessions.
Unit of Measure: Proportion (%) of intervention participants completing core FCU components using means, medians, and relevant quantiles.
Data Source: Structured intervention delivery logs
Engagement in Everyday Parenting (EDP) Sessions — During Intervention- on average 6 sessions Description: Among participants for whom parenting support is indicated, engagement will be assessed by participation in at least one EDP session.
Unit of Measure: Proportion (%) of indicated participants attending EDP sessions using means, medians, and relevant quantiles.
Data Source: Intervention delivery logs
Receipt of Navigation and Linkage Activities — During Intervention- Up to 1 year Description: Among participants for whom service navigation is indicated, uptake will be assessed by receipt of navigation and linkage activities.
Unit of Measure: Proportion (%) of indicated participants receiving navigation services
Data Source: Intervention delivery logs
Dose of FCU Services Delivered — During entire study period- up to 12 months Description: Dose of FCU delivery within routine services will be assessed using routine service records documenting completion of FCU components, parenting support sessions, and navigation and linkage activities, when indicated.
Unit of Measure: Number and proportion (%) of completed FCU-related service components
Data Source: Routine service records and de-identified monthly provider logs
Timeliness of FCU Delivery — Time of intervention- on average 3-5 weeks Description: Timeliness of FCU delivery within routine services will be assessed as the elapsed time from randomization to completion of the FCU assessment and feedback.
Unit of Measure: Time (days) in intervention using means, medians, and relevant quantiles.
Data Source: REDCap enrollment records and intervention delivery logs
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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