Family Connections

NCT06662357 | Recruiting

• 1 other identifier: H79SM089682
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score

  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

  Baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months

• Changes in Children's Global Assessment Scale (CGAS) Score

  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

  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).

  Analysis of baseline and follow-up family perceptions of care (18 Questions): 1. \- Very Dissatisfied 2. \- Dissatisfied 3. \- Neither 4. \- Satisfied 5. \- Very Satisfied

  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

  Comparative analysis of access to care trends

  0-6 months

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

  Comparative analysis of service use trends

  6-12 months

Study Arms (2)

Active Comparator: Family Connections Intervention

ACTIVE COMPARATOR

Behavioral: Behavioral Treatment

Treatment as Usual

NO INTERVENTION

Interventions

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.

Active Comparator: Family Connections Intervention

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge Health Alliance: lead

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

RECRUITING

MeSH Terms

Conditions

Affective Symptoms; Child Behavior Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Katherine E Grimes, MD, MPH

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine E Grimes, MD, MPH

CONTACT

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

Program Administrator, MPH

CONTACT

857-260-2867; amaity@challiance.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Children's Health Initiative, Director

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 29, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

US (1)