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Recruiting NCT06662357

Family Connections

No phase Interventional Emotional Disturbance Behavior Disorders in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral Treatment.
Who it may be relevant to
Registry conditions: Emotional Disturbance, Behavior Disorders in Children. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score [Time frame: Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months]
  • Changes in Children's Global Assessment Scale (CGAS) Score [Time frame: 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). [Time frame: 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 [Time frame: 0-6 months]
  • Engagement in child mental health and substance abuse (MH/SA) treatment [Time frame: 6-12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Cambridge Health Alliance — Cambridge

Identifiers

NCT: NCT06662357 · H79SM089682 · H79SM089682

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗