Family Connections

NCT ID: NCT06662357

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2028-09-29

Brief Summary

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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.

Detailed Description

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Conditions

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Emotional Disturbance Behavior Disorders in Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Active Comparator: Family Connections Intervention

Group Type ACTIVE_COMPARATOR

Behavioral Treatment

Intervention Type 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.

Treatment as Usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambridge Health Alliance

OTHER

Sponsor Role lead

Responsible Party

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Katherine Grimes MD

Children's Health Initiative, Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine E Grimes, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Cambridge Health Alliance

Locations

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Cambridge Health Alliance

Cambridge, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katherine E Grimes, MD, MPH

Role: CONTACT

617-806-8718

Program Administrator, MPH

Role: CONTACT

857-260-2867

Facility Contacts

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Katherine Grimes, Md, MPH

Role: primary

857-523-8398

Other Identifiers

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H79SM089682

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H79SM089682

Identifier Type: -

Identifier Source: org_study_id

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