[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566990":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":35,"interventions":44,"overallOfficials":50,"centralContacts":54,"locations":63,"responsibleParty":81,"collaborators":27,"id":84,"slug":27,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":27,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":27,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":27,"overallStatus":65,"whyStopped":27,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Cambridge Health Alliance","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":27},[9,13,16,19,23],{"measure":10,"description":11,"timeFrame":12},"Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score","Comparative analysis of baseline and follow-up clinical functioning scores\n\nCAFAS Scoring:\n\nLevels of Dysfunction None or minimal 0-10 Mild 20-30 Moderate 40-60 Marked 70-80 Severe \\>90","Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months",{"measure":14,"description":15,"timeFrame":12},"Changes in Children's Global Assessment Scale (CGAS) Score","Comparative analysis of baseline and follow-up clinical functioning scores\n\nCGAS Scale:\n\n100-91 Superior functioning 90-81 Good functioning 80-71 No more than a slight impairment in functioning 70-61 Some difficulty in a single area, but generally functioning pretty well 60-51 Variable functioning with sporadic difficulties 50-41 Moderate degree of interference in functioning 40-31 Major impairment to functioning in several areas 30-21 Unable to function in almost all areas 20-11 Needs considerable supervision 10-1 Needs constant supervision",{"measure":17,"description":18,"timeFrame":12},"Family perceptions of care using the Family Professional Partnership Scale (FPPS).","Analysis of baseline and follow-up family perceptions of care (18 Questions):\n\n1. \\- Very Dissatisfied\n2. \\- Dissatisfied\n3. \\- Neither\n4. \\- Satisfied\n5. \\- Very Satisfied",{"measure":20,"description":21,"timeFrame":22},"Access to child mental health and substance abuse (MH\u002FSA) care","Comparative analysis of access to care trends","0-6 months",{"measure":24,"description":25,"timeFrame":26},"Engagement in child mental health and substance abuse (MH\u002FSA) treatment","Comparative analysis of service use trends","6-12 months",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"NON_RANDOMIZED","PARALLEL","The Family Connections Model consists of the delivery of intensively integrated clinical care within pediatrics, combined with community-based parent support from family support specialists. Innovations include child mental health specialists joining the pediatrics team for \"huddles\", psychiatry notes shared with pediatricians via the Electronic Medical Records and active inclusion of pediatricians in pre-evaluation discussions with the Family Connections Team and post-evaluation recommendations for the families. In addition, the Safety-Net model includes active communication with school personnel, child welfare, and community-based resources, when needed.","HEALTH_SERVICES_RESEARCH",{"masking":34,"maskingDescription":27,"whoMasked":27},"NONE",[36,41],{"label":37,"type":38,"description":27,"interventionNames":39},"Active Comparator: Family Connections Intervention","ACTIVE_COMPARATOR",[40],"Behavioral: Behavioral Treatment",{"label":42,"type":43,"description":27,"interventionNames":27},"Treatment as Usual","NO_INTERVENTION",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":27},"BEHAVIORAL","Behavioral Treatment","\"Family Connections\" Care Planning Team: Clinical expertise will be combined with peer-to-peer parent\u002Fguardian support for trauma-informed care delivery to both parent and child. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning.",[37],[51],{"name":52,"affiliation":5,"role":53},"Katherine E Grimes, MD, MPH","PRINCIPAL_INVESTIGATOR",[55,59],{"name":52,"role":56,"phone":57,"phoneExt":27,"email":58},"CONTACT","617-806-8718","katherine_grimes@hms.harvard.edu",{"name":60,"role":56,"phone":61,"phoneExt":27,"email":62},"Program Administrator, MPH","857-260-2867","amaity@challiance.org",[64],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Cambridge","Massachusetts","02139","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-71.10561,42.3751,{"lat":75,"lon":74},[78],{"name":79,"role":56,"phone":80,"phoneExt":27,"email":27},"Katherine Grimes, Md, MPH","857-523-8398",{"type":53,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Katherine Grimes MD","Children's Health Initiative, Director","100566990",false,"NCT06662357","Family Connections","Family Connections: A Community-Based Approach to Expanding Mental Health Access and Engagement for SED Youth","Inclusion Criteria:\n\n* 3 through 18 years (17½ years maximum at time of enrollment)\n* Referred by Primary Care Physician's (PCP) from one of the three Cambridge Health Alliance (CHA) primary care intervention sites to the Family Connections team for an integrated child mental health and\u002For substance use disorder clinical assessment.\n* Positive screen on CHA's standard pediatric mental health and substance use screening instruments, and\u002For parental concern about possible mental health\u002Fsubstance use needs, and\u002For PCP concern about possible mental health\u002Fsubstance use needs\n* Enrolled in MassHealth\n\nExclusion Criteria:\n\n* Subjects over 17.5 years (SAMHSA data collection required at 6 and 12 months after enrollment which must occur before age 18 years.)\n* Youth who are not enrolled in MassHealth\n* CHA patients with PCP located at CHA primary care site other than the identified intervention sites","ALL","3 Years","18 Years",{"count":94,"type":95},300,"ESTIMATED","INTERVENTIONAL",[98],"NA","The Family Connections study, is intended to disrupt disparities in mental health treatment access for children at-risk for childhood trauma (ACEs) and\u002For serious emotional disturbance (SED). \"Family Connections\" will use mobile clinical and family support teams to improve mental health outcomes. This clinical innovation, nested in an integrated system-of-care will be piloted for children, ages 3-18 yrs., with SED who receive primary care through Cambridge Health Alliance.",[101,102],"Emotional Disturbance","Behavior Disorders in Children","2025-06-25",{"date":105,"type":106},"2025-06-26","ACTUAL",{"date":108,"type":106},"2025-01-30",{"date":110,"type":95},"2028-09-29",{"name":5,"class":6},1]