Family Connections

Not Applicable

Recruiting

• Conditions: Emotional Disturbance; Behavior Disorders in Children

• Registration Number: NCT06662357
• Lead Sponsor: Cambridge Health Alliance

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-28
• Study Start: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2028-07
• Study Completion: 2028-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score	Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months	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
Changes in Children's Global Assessment Scale (CGAS) Score	Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months	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
Family perceptions of care using the Family Professional Partnership Scale (FPPS).	Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months	Analysis of baseline and follow-up family perceptions of care (18 Questions): 1. - Very Dissatisfied; 2. - Dissatisfied; 3. - Neither; 4. - Satisfied; 5. - Very Satisfied
Access to child mental health and substance abuse (MH/SA) care	0-6 months	Comparative analysis of access to care trends
Engagement in child mental health and substance abuse (MH/SA) treatment	6-12 months	Comparative analysis of service use trends

Trial Locations

Locations (1)

Cambridge Health Alliance; 🇺🇸 Cambridge, Massachusetts, United States