Recruiting

Observational Study

Sponsor:

Cambridge Health Alliance

Code:

NCT06662357

Conditions

Emotional Disturbance

Behavior Disorders in Children

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Interventions

Behavioral Treatment

Study Details

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.

Conditions

Emotional Disturbance

Behavior Disorders in Children

Study ID

NCT06662357

Start date

Jan 30, 2025

Status verified date

Jun, 2025

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Active Comparator: Family Connections Intervention

no intervention: Treatment as Usual

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Katherine E Grimes, MD, MPH

617-806-8718katherine_grimes@hms.harvard.edu

Program Administrator, MPH

857-260-2867amaity@challiance.org

Locations

Cambridge Health Alliance

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Katherine Grimes, Md, MPH

857-523-8398

More Information

Sponsor

Cambridge Health Alliance

Last update posted

Jun 26, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cambridge Health Alliance on 2025-06-26.