Family STEPS: Family Check-Up+

NCT07433361 | Not Yet Recruiting

• 1 other identifier: 19754
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Behavior Problem

Keywords

child behavior problem; parenting; parental capacity

Outcome Measures

Primary Outcomes (8)

• Recruitment Rate

  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

  During recruitment - pre-randomization

• Fidelity to FCU Delivery

  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

  During Intervention- on average 3-5 weeks

• Retention

  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

  3, 6, 9, and 12 months post-randomization

• Completion of Core FCU Components

  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

  During Intervention - on average 3-5 weeks

• Engagement in Everyday Parenting (EDP) 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

  During Intervention- on average 6 sessions

• Receipt of Navigation and Linkage Activities

  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

  During Intervention- Up to 1 year

• Dose of FCU Services Delivered

  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

  During entire study period- up to 12 months

• Timeliness of FCU Delivery

  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

  Time of intervention- on average 3-5 weeks

Secondary Outcomes (2)

• Child emotional/behavioural problems

  Baseline, 6-months, 12 months

• Parenting Practices

  Baseline, 6 months, 12 months

Study Arms (2)

Family Check Up +

EXPERIMENTAL

Caregivers randomized to this arm (n=1500) will receive the Family Check-Up Program

Behavioral: Family Check Up

Treatment as Usual

ACTIVE COMPARATOR

Caregivers randomized to this arm (n=150) will receive either a different program, or brief services

Behavioral: Family Check Up

Interventions

Family Check Up BEHAVIORAL

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.

Also known as: FCU

Family Check Up +; Treatment as Usual

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Families with in sufficient knowledge of English, Families with caregivers incapable of giving informed written consent

Sponsors & Collaborators

• McMaster University: lead
• Institute for Clinical Evaluative Sciences: collaborator
• Public Health Agency of Canada (PHAC): collaborator
• University of Exeter: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S3K1, Canada

Location

Study Officials

• Andrea Gonzalez, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Gonzalez, PhD

CONTACT

9055101652; gonzal@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)