Child Behavior ProblemFamilySTEPSNCT07433361
Family STEPS: Family Check-Up+
A study testing Family Check Up in people with Child Behavior Problem, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Problem
- What is being tested?
- Family Check Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Families with in sufficient knowledge of English, Families with caregivers incapable of giving informed written consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McMaster University
Hamilton, Ontario, L8S3K1
Andrea Gonzalez, PhD, 905-510-1652, gonzal@mcmaster.ca
About this study
Official title: CHAMPP4KIDS: Family STEPS: Tailored, Stepped Prevention Strategy Using the 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.
Read the detailed description
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.
- Conditions
- Child Behavior Problem
- Being tested
- Family Check Up
- Keywords
- child behavior problem, parenting, parental capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check UpBehavioural
Also called FCU
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 group | Role | What they receive |
|---|---|---|
| Family Check Up + | Experimental | Caregivers randomized to this arm (n=1500) will receive the Family Check-Up Program Receives: 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 Receives: Behavioral: Family Check Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Time of intervention- on average 3-5 weeks
Secondary outcomes (2)
Child emotional/behavioural problems
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
Measured: Baseline, 6-months, 12 months
Parenting Practices
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.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Public Health Agency of Canada (PHAC), University of Exeter
- Responsible party
- Principal investigator, Andrea Gonzalez (for Nathan), McMaster University
- Investigators
- Andrea Gonzalez, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433361
- Sponsor's protocol ID
- 19754
- Acronym
- FamilySTEPS
- Status last verified
- Feb 2026
- First submitted
- 17 Dec 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHAMPP4KIDS: Family STEPS: Tailored, Stepped Prevention Strategy Using the Family Check-Up+
- ClinicalTrials.gov ID
- NCT07433361
- Acronym / sponsor ID
- FamilySTEPS / 19754
- Conditions
- Child Behavior Problem
- Keywords
- child behavior problem, parenting, parental capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Public Health Agency of Canada (PHAC), University of Exeter
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Check Up + | Experimental | Behavioral: Family Check UpCaregivers randomized to this arm (n=1500) will receive the Family Check-Up Program |
| Treatment as Usual | Active comparator | Behavioral: Family Check UpCaregivers randomized to this arm (n=150) will receive either a different program, or brief services |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Families with in sufficient knowledge of English, Families with caregivers incapable of giving informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Check UpAlso: FCUThe 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. | Behavioural | Family Check Up +, Treatment as Usual |
Primary outcome
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
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
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
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
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
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
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
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
2 secondary outcomes
Child emotional/behavioural problems
Time frame: Baseline, 6-months, 12 months
Parenting Practices
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Gonzalez, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check Up in people with Child Behavior Problem, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Gonzalez, PhD (9055101652, gonzal@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: During recruitment - pre-randomization). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.