Clinical trial NCT06662357: Family Connections
Official title: Family Connections: A Community-Based Approach to Expanding Mental Health Access and Engagement for SED Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Disturbance
Behavior Disorders in Children
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score
timeFrame: Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months
measure: Changes in Children's Global Assessment Scale (CGAS) Score
timeFrame: Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months
measure: Family perceptions of care using the Family Professional Partnership Scale (FPPS).
timeFrame: Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months
measure: Access to child mental health and substance abuse (MH/SA) care
timeFrame: 0-6 months
measure: Engagement in child mental health and substance abuse (MH/SA) treatment
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Katherine E Grimes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: