ClinicalTrials.gg
RecruitingNCT06662357Updated Oct 22, 2026

Family Connections

An interventional study of Behavioral Treatment in Emotional Disturbance and Behavior Disorders in Children, sponsored by Cambridge Health Alliance. Recruiting at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Emotional Disturbance
  • Behavior Disorders in Children
03

In context

Affective Symptoms

85 studies on the registry are indexed under Affective Symptoms; 20 are open to participants now.

This study's planned enrollment of 300 is above the median of 80 across 63 interventional studies indexed under Affective Symptoms.

Browse Affective Symptoms studies →

Lead sponsor

Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Active Comparator: Family Connections Intervention

    Behavioral: Behavioral Treatment

  • No intervention
    Treatment as Usual

Interventions

  • BehavioralBehavioral 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.

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

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

    Comparative analysis of access to care trends

    Time frame: 0-6 months

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

    Comparative analysis of service use trends

    Time frame: 6-12 months

07

Study locations

1 of 1 sites recruiting
  • Cambridge Health Alliance
    Cambridge, Massachusetts 02139, United States
    Recruiting
    • Katherine Grimes, Md, MPH · Contact857-523-8398
08

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and oversight details
1 update, last Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Minor edits only
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06662357
Lead sponsor
Cambridge Health Alliance
Responsible party
Katherine Grimes MD (Children's Health Initiative, Director, Cambridge Health Alliance) — Principal investigator
First posted
Oct 28, 2024
Start date
Jan 30, 2025
Primary completion
Jul 2028 (estimated)
Completion
Sep 29, 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Katherine E Grimes, MD, MPH
Contact
katherine_grimes@hms.harvard.edu
617-806-8718
Program Administrator, MPH
Contact
amaity@challiance.org
857-260-2867
Katherine E Grimes, MD, MPH
principal investigator · Cambridge Health Alliance

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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