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NCT Number: NCT07433361

Family STEPS: Family Check-Up+

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The overall goal of the evaluation is to assess the extent to which the target population is reached and retained in FCU+ within routine service settings. Reach will be evaluated through recruitment rates (the proportion of eligible families who consent and enroll), retention (the proportion of randomized participants completing follow-up assessments), and family-level uptake of FCU+ intervention components. Second, we aim to provide robust evidence about the implementation and effectiveness of the Family Check-Up program, in the province of Ontario, on parenting practices and functioning, and child emotional behaviour problems outcomes. The investigators will conduct a ua pilot pragmatic Hybrid Type II individually randomized controlled trial conducted within routine service settings with 300 participating caregivers to compare the Family Check-Up (FCU) to treatment as usual (TAU) . Participants will be randomly assigned to one of the two conditions using stratified (by site) block randomization. All participants will undergo screening and a baseline assessment before randomization. Once randomized, the FCU participants will begin their sessions and the TAU participants will receive a different program, or short therapy sessions. Caregivers will complete a baseline research assessment and follow-up assessments at 6- and 12-months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: FCU

Primary outcomes

  1. Recruitment Rate

    Time frame: 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

  2. Fidelity to FCU Delivery

    Time frame: 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

  3. Retention

    Time frame: 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

  4. Completion of Core FCU Components

    Time frame: 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

  5. Engagement in Everyday Parenting (EDP) Sessions

    Time frame: 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

  6. Receipt of Navigation and Linkage Activities

    Time frame: 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

  7. Dose of FCU Services Delivered

    Time frame: 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

  8. Timeliness of FCU Delivery

    Time frame: 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

Secondary outcomes

  1. Child emotional/behavioural problems

    Time frame: Baseline, 6-months, 12 months

    The investigators will measure change in child emotional and behavioural problems across time points using the Strengths and Difficulties Questionnaire (SDQ). The questionnaire consists of 25 questions divided into five scales. The prosocial behaviour scale showcases strengths, while the remaining four evaluate negative behaviours such as emotional symptoms, conduct problems, hyperactivity and inattention, and peer relationship problem.

    Add the scores of all the items in the first four subscales (Emotional Symptoms + Conduct Problems + Hyperactivity/Inattention + Peer Relationship Problems). The Total Difficulties Score represents the overall level of emotional and behavioral difficulties.

    Scoring: total score can range from 0-50 cut offs: 0 to 12: Close to Average 13 to 15: Slightly Raised 16 to 18: High 19 and above: Very High

  2. Parenting Practices

    Time frame: Baseline, 6 months, 12 months

    Discipline style measured using the Parenting Scale. The 25-item questionnaire has each item rated on a 7-point scale, measures three stable factors of dysfunctional discipline. Scores for each question range from 1-7 with a total score ranging from 25-175. Higher scores indicate dysfunctional parenting.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Gonzalez, PhD

CONTACT

[email protected]

9055101652

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

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

Registry information

Official study title

CHAMPP4KIDS: Family STEPS: Tailored, Stepped Prevention Strategy Using the Family Check-Up+

Acronym: FamilySTEPS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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