Emotional DisturbanceNCT06662357
Family Connections
A study testing Behavioral Treatment in people with Emotional Disturbance and Behavior Disorders in Children, run by Cambridge Health Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Emotional Disturbance, Behavior Disorders in Children
- What is being tested?
- Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 29 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cambridge Health Alliance
Cambridge, Massachusetts, 02139
Katherine Grimes, Md, MPH, 857-523-8398
About this study
Official title: Family Connections: A Community-Based Approach to Expanding Mental Health Access and Engagement for SED Youth
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.
- Being tested
- Behavioral Treatment
- Medical subject headings
- Affective Symptoms, Child Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentBehavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Family Connections Intervention | Active comparator | Not described Receives: Behavioral: Behavioral Treatment |
| Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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):
- - Very Dissatisfied
- - Dissatisfied
- - Neither
- - Satisfied
- - Very Satisfied
Measured: 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
Measured: 0-6 months
Engagement in child mental health and substance abuse (MH/SA) treatment
Comparative analysis of service use trends
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start30 Jan 2025
- Primary completionJul 2028 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Grimes MD, Cambridge Health Alliance
- Investigators
- Katherine E Grimes, MD, MPH, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662357
- Sponsor's protocol ID
- H79SM089682
- Other IDs
- H79SM089682
- Status last verified
- Sep 2026
- First submitted
- 25 Oct 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Connections: A Community-Based Approach to Expanding Mental Health Access and Engagement for SED Youth
- ClinicalTrials.gov ID
- NCT06662357
- Acronym / sponsor ID
- H79SM089682
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Family Connections Intervention | Active comparator | Behavioral: Behavioral Treatment |
| Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Active Comparator: Family Connections Intervention |
Primary outcome
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
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
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): 1. - Very Dissatisfied 2. - Dissatisfied 3. - Neither 4. - Satisfied 5. - Very Satisfied
Access to child mental health and substance abuse (MH/SA) care
Time frame: 0-6 months
Comparative analysis of access to care trends
Engagement in child mental health and substance abuse (MH/SA) treatment
Time frame: 6-12 months
Comparative analysis of service use trends
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine E Grimes, MD, MPH principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Treatment in people with Emotional Disturbance and Behavior Disorders in Children, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine E Grimes, MD, MPH (617-806-8718, katherine_grimes@hms.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.