[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626263":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":56,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":35,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":89,"whyStopped":35,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Family Check Up +","EXPERIMENTAL","Caregivers randomized to this arm (n=1500) will receive the Family Check-Up Program",[13],"Behavioral: Family Check Up",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as Usual","ACTIVE_COMPARATOR","Caregivers randomized to this arm (n=150) will receive either a different program, or brief services",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9,15],[26],"FCU",[28],{"name":29,"affiliation":5,"role":30},"Andrea Gonzalez, PhD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","9055101652",null,"gonzal@mcmaster.ca",[38],{"facility":5,"status":35,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hamilton","Ontario","L8S3K1","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-79.84963,43.25011,{"lat":48,"lon":47},[51],{"name":29,"role":33,"phone":52,"phoneExt":35,"email":36},"905-510-1652",{"type":30,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Andrea Gonzalez (for Nathan)","Associate Professor",[57,59,62],{"name":58,"class":6},"Institute for Clinical Evaluative Sciences",{"name":60,"class":61},"Public Health Agency of Canada (PHAC)","OTHER_GOV",{"name":63,"class":6},"University of Exeter","100626263","family-steps-family-check-up-100626263",false,"NCT07433361","Family STEPS: Family Check-Up+","CHAMPP4KIDS: Family STEPS: Tailored, Stepped Prevention Strategy Using the Family Check-Up+","FamilySTEPS","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",true,"ALL","2 Years","6 Years",{"count":77,"type":78},300,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84],"Child Behavior Problem",[86,87,88],"child behavior problem","parenting","parental capacity","NOT_YET_RECRUITING","2026-02-19",{"date":92,"type":93},"2026-02-25","ACTUAL",{"date":95,"type":78},"2026-04-01",{"date":97,"type":78},"2029-12-31",{"name":5,"class":6},1]