Family Connections

Family Connections: A Community-Based Approach to Expanding Mental Health Access and Engagement for SED Youth

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.

Study Overview

• Status: Recruiting
• Conditions: Emotional Disturbance; Behavior Disorders in Children
• Intervention / Treatment: Behavioral: Behavioral Treatment

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine E Grimes, MD, MPH; Phone Number: 617-806-8718; Email: katherine_grimes@hms.harvard.edu
• Study Contact Backup: Name: Program Administrator, MPH; Phone Number: 857-260-2867; Email: amaity@challiance.org

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Recruiting
      • Cambridge Health Alliance
      • Contact: Katherine Grimes, Md, MPH; Phone Number: 857-523-8398

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual
Active Comparator: Active Comparator: Family Connections Intervention	Behavioral: Behavioral Treatment; "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months
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	Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months
Family perceptions of care using the Family Professional Partnership Scale (FPPS).	Analysis of baseline and follow-up family perceptions of care (18 Questions): - Very Dissatisfied; - Dissatisfied; - Neither; - Satisfied; - Very Satisfied	Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months
Access to child mental health and substance abuse (MH/SA) care	Comparative analysis of access to care trends	0-6 months
Engagement in child mental health and substance abuse (MH/SA) treatment	Comparative analysis of service use trends	6-12 months

Collaborators and Investigators

• Sponsor: Cambridge Health Alliance
• Investigators: Principal Investigator: Katherine E Grimes, MD, MPH, Cambridge Health Alliance

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 29, 2028

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Neurodevelopmental Disorders; Mental Disorders; Affective Symptoms; Child Behavior Disorders
• Other Study ID Numbers: H79SM089682 (Other Grant/Funding Number: SAMHSA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No