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NCT Number: NCT06662357

Family Connections

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.

Recruiting

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Key information

Conditions

Emotional Disturbance Affective Symptoms Behavior Behavior Disorders in Children Behavioral Symptoms Child Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location status: Recruiting

Location contact

Katherine Grimes, Md, MPH

CONTACT

857-523-8398

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Treatment

Behavioral

"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 outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    Analysis of baseline and follow-up family perceptions of care (18 Questions):

    • - Very Dissatisfied
    • - Dissatisfied
    • - Neither
    • - Satisfied
    • - Very Satisfied

  4. Access to child mental health and substance abuse (MH/SA) care

    Time frame: 0-6 months

    Comparative analysis of access to care trends

  5. Engagement in child mental health and substance abuse (MH/SA) treatment

    Time frame: 6-12 months

    Comparative analysis of service use trends

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine E Grimes, MD, MPH

CONTACT

[email protected]

617-806-8718

Program Administrator, MPH

CONTACT

[email protected]

857-260-2867

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 28, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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