Family Connections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorCambridge Health Alliance
About this trial
The Family Connections study, is intended to disrupt disparities in mental health treatment access for children at-risk for childhood trauma (ACEs) and/or 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
3 through 18 years (17½ years maximum at time of enrollment)
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/or substance use disorder clinical assessment.
Positive screen on CHA's standard pediatric mental health and substance use screening instruments, and/or parental concern about possible mental health/substance use needs, and/or PCP concern about possible mental health/substance use needs
Enrolled in MassHealth
Disqualifiers
Subjects over 17.5 years (SAMHSA data collection required at 6 and 12 months after enrollment which must occur before age 18 years.)
Youth who are not enrolled in MassHealth
CHA patients with PCP located at CHA primary care site other than the identified intervention sites
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral Treatment
Behavioral"Family Connections" Care Planning Team: Clinical expertise will be combined with peer-to-peer parent/guardian 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Active Comparator: Family Connections InterventionActive comparator 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score
Comparative analysis of baseline and follow-up clinical functioning scores CAFAS Scoring: Levels of Dysfunction None or minimal 0-10 Mild 20-30 Moderate 40-60 Marked 70-80 Severe \>90
Time frame
Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months2
Changes in Children's Global Assessment Scale (CGAS) Score
Comparative analysis of baseline and follow-up clinical functioning scores CGAS Scale: 100-91 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
Time frame
Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months3
Family perceptions of care using the Family Professional Partnership Scale (FPPS).
Analysis of baseline and follow-up family perceptions of care (18 Questions): 1. \- Very Dissatisfied 2. \- Dissatisfied 3. \- Neither 4. \- Satisfied 5. \- Very Satisfied
Time frame
Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months4
Access to child mental health and substance abuse (MH/SA) care
Comparative analysis of access to care trends
Time frame
0-6 monthsSponsors and contacts
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Source ClinicalTrials.gov