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Family Connections

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06662357
Enrollment
300
Registered
2024-10-28
Start date
2025-01-30
Completion date
2028-09-29
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior Disorders in Children, Emotional Disturbance

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.

Interventions

BEHAVIORALBehavioral 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.

Sponsors

Cambridge Health Alliance
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Child and Adolescent Functional Assessment Scale (CAFAS) ScoreBaseline collected at enrollment, follow-up assessments collected at 6 months and 12 monthsComparative 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) ScoreBaseline collected at enrollment, follow-up assessments collected at 6 months and 12 monthsComparative 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 monthsAnalysis 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) care0-6 monthsComparative analysis of access to care trends
Engagement in child mental health and substance abuse (MH/SA) treatment6-12 monthsComparative analysis of service use trends

Countries

United States

Contacts

Primary ContactKatherine E Grimes, MD, MPH
katherine_grimes@hms.harvard.edu617-806-8718
Backup ContactProgram Administrator, MPH
amaity@challiance.org857-260-2867

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026