Family STEPS: Family Check-Up+ (NCT07433361) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Family STEPS: Family Check-Up+
Canada300 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
2 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Rate
Timeframe: During recruitment - pre-randomization
2
Fidelity to FCU Delivery
Timeframe: During Intervention- on average 3-5 weeks
3
Retention
Timeframe: 3, 6, 9, and 12 months post-randomization
4
Completion of Core FCU Components
Timeframe: During Intervention - on average 3-5 weeks
5
Engagement in Everyday Parenting (EDP) Sessions
Timeframe: During Intervention- on average 6 sessions
6
Receipt of Navigation and Linkage Activities
Timeframe: During Intervention- Up to 1 year
7
Dose of FCU Services Delivered
Timeframe: During entire study period- up to 12 months