Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:31 PM
Study NCT ID:
NCT07433361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family STEPS: Family Check-Up+
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate', 'timeFrame': 'During recruitment - pre-randomization', 'description': '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.\n\nUnit 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.\n\nRecruitment feasibility will be assessed based on the proportion of eligible families who consent and enroll:\n\n* Green: ≥60% of eligible families approached enroll\n* Amber: 40-59% enroll\n* Red: \\<40% enroll\n\nData Source: Study screening logs and REDCap enrollment records'}, {'measure': 'Fidelity to FCU Delivery', 'timeFrame': 'During Intervention- on average 3-5 weeks', 'description': '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.\n\nUnit 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\n\nData Source: Coded video-recorded sessions and fidelity rating forms'}, {'measure': 'Retention', 'timeFrame': '3, 6, 9, and 12 months post-randomization', 'description': 'Description: Retention will be assessed as the proportion of randomized participants who complete follow-up assessments at each scheduled time point.\n\nRetention 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:\n\n* Main follow-ups (6 and 12 months):\n\n * Green: ≥80% retained at 6 months and ≥75% retained at 12 months\n * Amber: 70-79% retained at 6 months and/or 65-74% retained at 12 months\n * Red: \\<70% retained at 6 months or \\<65% retained at 12 months\n* Short follow-ups (3 and 9 months):\n\n * Green: ≥75% completion\n * Amber: 65-74% completion\n * Red: \\<65% completion retained at 12 months:\n* Green: ≥75% provide complete parenting and child outcome measures\n* Amber: 65-74% complete data\n* Red: \\<65% complete data\n\nData Source: REDCap follow-up records'}, {'measure': 'Completion of Core FCU Components', 'timeFrame': 'During Intervention - on average 3-5 weeks', 'description': 'Description: Within the intervention arm, uptake of core FCU components will be assessed by completion of the assessment and feedback sessions.\n\nUnit of Measure: Proportion (%) of intervention participants completing core FCU components using means, medians, and relevant quantiles.\n\nData Source: Structured intervention delivery logs'}, {'measure': 'Engagement in Everyday Parenting (EDP) Sessions', 'timeFrame': 'During Intervention- on average 6 sessions', 'description': 'Description: Among participants for whom parenting support is indicated, engagement will be assessed by participation in at least one EDP session.\n\nUnit of Measure: Proportion (%) of indicated participants attending EDP sessions using means, medians, and relevant quantiles.\n\nData Source: Intervention delivery logs'}, {'measure': 'Receipt of Navigation and Linkage Activities', 'timeFrame': 'During Intervention- Up to 1 year', 'description': 'Description: Among participants for whom service navigation is indicated, uptake will be assessed by receipt of navigation and linkage activities.\n\nUnit of Measure: Proportion (%) of indicated participants receiving navigation services\n\nData Source: Intervention delivery logs'}, {'measure': 'Dose of FCU Services Delivered', 'timeFrame': 'During entire study period- up to 12 months', 'description': '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.\n\nUnit of Measure: Number and proportion (%) of completed FCU-related service components\n\nData Source: Routine service records and de-identified monthly provider logs'}, {'measure': 'Timeliness of FCU Delivery', 'timeFrame': 'Time of intervention- on average 3-5 weeks', 'description': '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.\n\nUnit of Measure: Time (days) in intervention using means, medians, and relevant quantiles.\n\nData Source: REDCap enrollment records and intervention delivery logs'}], 'secondaryOutcomes': [{'measure': 'Child emotional/behavioural problems', 'timeFrame': 'Baseline, 6-months, 12 months', 'description': '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.\n\nAdd 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.\n\nScoring: 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'}, {'measure': 'Parenting Practices', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child behavior problem', 'parenting', 'parental capacity'], 'conditions': ['Child Behavior Problem']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Custodial caregiver of child is aged 2 to 6 years at time of screening.\n* Families with sufficient knowledge of English needed for assessment measures.\n* Caregivers capable of giving informed, written consent.\n* Definition of 'at-risk' as measured by (a) or (b)as outlined below:\n\nparental 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\n\nExclusion Criteria:\n\n* Families with in sufficient knowledge of English, Families with caregivers incapable of giving informed written consent"}, 'identificationModule': {'nctId': 'NCT07433361', 'acronym': 'FamilySTEPS', 'briefTitle': 'Family STEPS: Family Check-Up+', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'CHAMPP4KIDS: Family STEPS: Tailored, Stepped Prevention Strategy Using the Family Check-Up+', 'orgStudyIdInfo': {'id': '19754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family Check Up +', 'description': 'Caregivers randomized to this arm (n=1500) will receive the Family Check-Up Program', 'interventionNames': ['Behavioral: Family Check Up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as Usual', 'description': 'Caregivers randomized to this arm (n=150) will receive either a different program, or brief services', 'interventionNames': ['Behavioral: Family Check Up']}], 'interventions': [{'name': 'Family Check Up', 'type': 'BEHAVIORAL', 'otherNames': ['FCU'], 'description': '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.', 'armGroupLabels': ['Family Check Up +', 'Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S3K1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Andrea Gonzalez, PhD', 'role': 'CONTACT', 'email': 'gonzal@mcmaster.ca', 'phone': '905-510-1652'}], 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Andrea Gonzalez, PhD', 'role': 'CONTACT', 'email': 'gonzal@mcmaster.ca', 'phone': '9055101652'}], 'overallOfficials': [{'name': 'Andrea Gonzalez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Clinical Evaluative Sciences', 'class': 'OTHER'}, {'name': 'Public Health Agency of Canada (PHAC)', 'class': 'OTHER_GOV'}, {'name': 'University of Exeter', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrea Gonzalez (for Nathan)', 'investigatorAffiliation': 'McMaster University'}}}}