Family STEPS: Family Check-Up+
NCT07433361 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-02-25
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
Interventions
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
Institute for Clinical Evaluative Sciences
collaborator OTHER -
Public Health Agency of Canada (PHAC)
collaborator OTHER_GOV -
University of Exeter
collaborator OTHER - lead OTHER
Principal Investigators
-
Andrea Gonzalez, PhD · McMaster University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
Countries
- Canada
Study Locations
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