Pediatric Mental Health ServicesE-SOCNCT03637478
Enhancing Systems of Care: Supporting Families and Improving Youth Outcomes
A study testing Enhanced Systems of Care Team in people with Pediatric Mental Health Services, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
The aim of the study is to improve access to child mental health and substance abuse (MH/SA) care by expanding primary care screening and increasing availability of timely mental health evaluation and treatment. Read more about this study
- Who is it for?
- Ages 0 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Mental Health Services
- What is being tested?
- Enhanced Systems of Care Team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2017to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be between ages 0 to 17.5 years
- Referred by primary care physician at one of these Cambridge Health Alliance clinics: Windsor Street Care Center, Broadway Care Center, Everett Care Center, Malden Family Medicine Center
- Referred youth must have a caregiver (a parent of guardian) who agrees to participate in the assessment and treatment process
Who cannot join
- 17.6 years or older
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Cambridge, Massachusetts, 02141
About this study
The aim of the study is to improve access to child mental health and substance abuse (MH/SA) care by expanding primary care screening and increasing availability of timely mental health evaluation and treatment.
Read the detailed description
This is a quasi-experimental, longitudinal study. Identified youth and families will receive the intervention within the four study site clinic locations. Comparison group families will receive usual care. Each primary care study site will have designated Family Support Specialist, Clinical Care Manager and Child Psychiatry resources. The intervention includes an integrated care consultation which combines diagnostic evaluation, family assessment, and multi-disciplinary, team-based treatment recommendations, with follow-up community linkages and support, as indicated.
- Conditions
- Pediatric Mental Health Services
- Being tested
- Enhanced Systems of Care Team
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Systems of Care TeamBehavioural
E-SOC team will be increasing connections between clinical care and community partners, such as schools, juvenile justice and child-serving state agencies, to reduce disparities in access to mental health/substance use evaluation and treatment. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning. Overall goals are: earlier identification of mental health needs including child trauma; increased treatment access and adherence; care delivered in least restrictive settings; care experience reflecting active youth and family engagement; program sustainability and replicability.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Systems of Care Team | Experimental | The four intervention sites have been selected based on their size: taken together, their pediatric populations comprise over 80% of the total number of children receiving care at Cambridge Health Alliance. At the four intervention sites, the study will involve: 1) an integrated child mental health assessment done by the E-SOC team within primary care, 2) active follow-up, collaboration with specialty providers and support to families, 3) School, child welfare and other community linkages as appropriate. Receives: Behavioral: Enhanced Systems of Care Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access to child mental health and substance abuse (MH/SA) care
Service Use Data from Electronic Health Records and Claims for intervention group versus controls
Measured: Comparative analysis of access to care trends (0-6 months)
Engagement in child mental health and substance abuse (MH/SA) treatment
Service Use Data from Electronic Health Records and Claims for intervention group versus controls
Measured: Comparative analysis of service use trends (6-12 months)
Secondary outcomes (3)
Family Care Experience
Qualitative assessment of family perceptions of care using the Family Professional Partnership Scale (FPPS). The anchors of items rated on satisfaction are rated on a 5-point likert scale, where 1 = very dissatisfied, 3 = neither satisfied nor dissatisfied, and 5 = very satisfied wherein the higher the value represents a better outcome.
Measured: Analysis of baseline and follow-up family perceptions of care (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)
Changes in Children's Global Assessment Scale (CGAS) Score
Measurement of clinical functioning using Children's Global Assessment Scale (CGAS). Trends from baseline to 6 months and 12 months will be examined to identify improvement, decline, or no change in clinical functioning.The CGAS measure provides a single global rating only, on scale of 0-100, where scores below 60 indicate clinical need.
Measured: Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)
Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score
Measurement of clinical functioning using Child and Adolescent Functional Assessment Scale (CAFAS). Trends from baseline to 6 months and 12 months will be examined to identify improvement, decline, or no change in clinical functioning. The CAFAS measure indicates the level of clinical functioning, on a scale of 0-140, where scores above 40 indicate clinical need.
Measured: Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start17 Oct 2017
- Primary completion31 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Mental Health ServicesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The E-SOC 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 E-SOC Team and post-evaluation recommendations for the families. In addition, the E-SOC model includes active communication with school personnel, child welfare, and community-based resources, when needed.
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Grimes MD, Harvard Medical School (HMS and HSDM)
- Investigators
- Katherine E Grimes, MD, MPH, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637478
- Sponsor's protocol ID
- CHR-IRB-1062/04/17
- Acronym
- E-SOC
- Status last verified
- Oct 2020
- First submitted
- 19 Jul 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Systems of Care: Supporting Families and Improving Youth Outcomes
- ClinicalTrials.gov ID
- NCT03637478
- Acronym / sponsor ID
- E-SOC / CHR-IRB-1062/04/17
- Conditions
- Pediatric Mental Health Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 20 Aug 2018 (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 aim of the study is to improve access to child mental health and substance abuse (MH/SA) care by expanding primary care screening and increasing availability of timely mental health evaluation and treatment.
Detailed description
This is a quasi-experimental, longitudinal study. Identified youth and families will receive the intervention within the four study site clinic locations. Comparison group families will receive usual care. Each primary care study site will have designated Family Support Specialist, Clinical Care Manager and Child Psychiatry resources. The intervention includes an integrated care consultation which combines diagnostic evaluation, family assessment, and multi-disciplinary, team-based treatment recommendations, with follow-up community linkages and support, as indicated.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The E-SOC 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 E-SOC Team and post-evaluation recommendations for the families. In addition, the E-SOC model includes active communication with school personnel, child welfare, and community-based resources, when needed.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Systems of Care Team | Experimental | Behavioral: Enhanced Systems of Care TeamThe four intervention sites have been selected based on their size: taken together, their pediatric populations comprise over 80% of the total number of children receiving care at Cambridge Health Alliance. At the four intervention sites, the study will involve: 1) an integrated child mental health assessment done by the E-SOC team within primary care, 2) active follow-up, collaboration with specialty providers and support to families, 3) School, child welfare and other community linkages as appropriate. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Must be between ages 0 to 17.5 years
- Referred by primary care physician at one of these Cambridge Health Alliance clinics: Windsor Street Care Center, Broadway Care Center, Everett Care Center, Malden Family Medicine Center
- Referred youth must have a caregiver (a parent of guardian) who agrees to participate in the assessment and treatment process
Key exclusion criteria (1 listed)
- 17.6 years or older
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 |
|---|---|---|
| Enhanced Systems of Care TeamE-SOC team will be increasing connections between clinical care and community partners, such as schools, juvenile justice and child-serving state agencies, to reduce disparities in access to mental health/substance use evaluation and treatment. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning. Overall goals are: earlier identification of mental health needs including child trauma; increased treatment access and adherence; care delivered in least restrictive settings; care experience reflecting active youth and family engagement; program sustainability and replicability. | Behavioural | Enhanced Systems of Care Team |
Primary outcome
Access to child mental health and substance abuse (MH/SA) care
Time frame: Comparative analysis of access to care trends (0-6 months)
Service Use Data from Electronic Health Records and Claims for intervention group versus controls
Engagement in child mental health and substance abuse (MH/SA) treatment
Time frame: Comparative analysis of service use trends (6-12 months)
Service Use Data from Electronic Health Records and Claims for intervention group versus controls
3 secondary outcomes
Family Care Experience
Time frame: Analysis of baseline and follow-up family perceptions of care (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)
Changes in Children's Global Assessment Scale (CGAS) Score
Time frame: Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)
Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score
Time frame: Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Enhanced Systems of Care Team in people with Pediatric Mental Health Services, 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 20 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access to child mental health and substance abuse (MH/SA) care (time frame: Comparative analysis of access to care trends (0-6 months)). The study lists 2 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 20 Oct 2020.