H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation (H3)
Primary Purpose
Developmental Delay, Mental Health Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
H3 Services
Sponsored by
About this trial
This is an interventional health services research trial for Developmental Delay focused on measuring Depression, Children, Anxiety
Eligibility Criteria
Inclusion Criteria:
- between the ages of 0.0-16.99 years
- speaks Spanish or English
- screens positive for a developmental delay or mental health problem
- referral to the H3 care program by a pediatrician based on clinical judgment
- no prior history of receiving any H3 services in the past year
Exclusion Criteria (based on the child's characteristics):
- 17 years old (to avoid reconsent at 12 month follow-up)
- has previously had H3 services in the past year
- can not speak English or Spanish
Sites / Locations
- Miles Square Health Center, Englewood
- Erie Family Health Center, West Town
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
H3 Parent/Child Dyads
Arm Description
A child is eligible for the H3 partnered evaluation if he or she is: 1) between the ages of 0.0-16.99 years; 2) speaks Spanish or English; 3) screens positive for a developmental delay or mental health problem. For children in the intervention groups, the additional eligibility criteria are: 1) referral to the H3 care program by a pediatrician based on clinical judgment; and 2) no prior history of receiving any H3 services in the past year.
Outcomes
Primary Outcome Measures
H3 intervention care processes
tracking administration (yes/no) of "brief mental health interventions", "referral to specialty mental health care", "use of co-located child psychiatrist", "detected need for primary care"
Secondary Outcome Measures
Mental health functioning
PHQ9
Child development
Pediatric Symptom Checklist
Child functioning
Columbia Impairment Scale
Response to trauma and resilience
Traumatic Events Screening Inventory
Care process delivered
Questionnaire administered at baseline, 3, 6, and 12 months asking parent and child about any care processes that he/she received.
Full Information
NCT ID
NCT02699814
First Posted
January 25, 2016
Last Updated
September 26, 2019
Sponsor
University of California, Los Angeles
Collaborators
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT02699814
Brief Title
H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation
Acronym
H3
Official Title
H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of Illinois at Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this project is to develop and pilot test a community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems that is replicable, effective, and sustainable. Project procedures include child mental health screening, on-site brief mental health interventions, referral to specialty mental health, use of co-located child psychiatrist, detection of need for primary care in specialty mental health program. Subjects will be enrolled for 1 year, with interviews at baseline and 3, 6 and 12 months.
Dr. Bonnie Zima at UCLA has been contracted by the project funder to design and implement the evaluation of the project, which includes developing data collection procedures, training staff on implementation of data collection workflow, coordinating with sites to ensure evaluation design and IRB protocols are followed, and coordinating with both study sites to verify data reliability.
Some potential anticipated risks include being uncomfortable answering questions associated with the measures used in the study, and although unlikely, someone may access participant information that is confidential. Some benefits include helping to find ways to improve how to deliver mental health care for children served in publicly-funded primary care and mental health clinics.
Detailed Description
UCLA is in charge of the evaluation of the H3 project, including evaluation design and overseeing data collection by project sites. UCLA will receive data collected by each site and perform the analysis of the data for the sites to be shared with the Illinois Children's Healthcare Foundation and clinic sites. This study will evaluate an existing intervention, meaning that participation in the evaluation is not required in order to receive H3 services.
The information below is included in the evaluation design document attached in 10.1, 1.0:
The overarching goal of the Healthy Minds, Healthy Children, Healthy Chicago Initiative (H3) is to develop a community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems that is replicable, effective, and sustainable.
The final study design is a longitudinal cohort study of 400 children ages 0-17 years and their families served at the two intervention clinic sites (n=200/site) The study time points are baseline, 3-, 6-, and 12-months.
The data sources are parent and youth report, and clinic administrative data when feasible for the programs to transfer these data following IRB-approved procedures. The unit of analysis is the child. The main proximal (or short term) clinical outcomes are related to the H3 intervention care processes (e.g., brief mental health interventions, referral to specialty mental health care, co-located child psychiatrist). The time period will likely vary by child depending on clinical need, but it is anticipated that most of these care processes will be provided during the early phase when the child and parent is introduced to the new care model. The main distal outcomes (or more long-term) are clinical improvement (e.g., child symptom reduction, improved functioning) and some correspond to the care process delivered (e.g., if parent receives parent training, improvement parenting skills are assessed). The time points for tracking clinical improvement are 3, 6 and 12 months after the baseline interview that is done when the parent and child are enrolled in the evaluation. The independent variables (or factors that may influence care processes and clinical outcomes) are child sociodemographic characteristics (e.g. age, sex, race/ethnicity), psychosocial complexity, and primary caregiver characteristics that the clinic team or Community Advisory Board deemed relevant (e.g., parenting stress, probable depression). Embedded within the description of a child's psychosocial complexity are indicators of social determinants (e.g. exposure to trauma) that may adversely impact a child's development and well-being.
Findings from this evaluation will provide data on the acceptability and feasibility of the H3 care models, as well as early indicators of whether these care models are promising.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Delay, Mental Health Disorder
Keywords
Depression, Children, Anxiety
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
H3 Parent/Child Dyads
Arm Type
Experimental
Arm Description
A child is eligible for the H3 partnered evaluation if he or she is: 1) between the ages of 0.0-16.99 years; 2) speaks Spanish or English; 3) screens positive for a developmental delay or mental health problem. For children in the intervention groups, the additional eligibility criteria are: 1) referral to the H3 care program by a pediatrician based on clinical judgment; and 2) no prior history of receiving any H3 services in the past year.
Intervention Type
Behavioral
Intervention Name(s)
H3 Services
Intervention Description
A community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems
Primary Outcome Measure Information:
Title
H3 intervention care processes
Description
tracking administration (yes/no) of "brief mental health interventions", "referral to specialty mental health care", "use of co-located child psychiatrist", "detected need for primary care"
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mental health functioning
Description
PHQ9
Time Frame
Baseline, 3, 6 and 12 months
Title
Child development
Description
Pediatric Symptom Checklist
Time Frame
12 monthsBaseline, 3, 6 and 12 months
Title
Child functioning
Description
Columbia Impairment Scale
Time Frame
Baseline, 3, 6 and 12 months
Title
Response to trauma and resilience
Description
Traumatic Events Screening Inventory
Time Frame
Baseline, 3, 6 and 12 months
Title
Care process delivered
Description
Questionnaire administered at baseline, 3, 6, and 12 months asking parent and child about any care processes that he/she received.
Time Frame
Baseline, 3, 6 and 12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between the ages of 0.0-16.99 years
speaks Spanish or English
screens positive for a developmental delay or mental health problem
referral to the H3 care program by a pediatrician based on clinical judgment
no prior history of receiving any H3 services in the past year
Exclusion Criteria (based on the child's characteristics):
17 years old (to avoid reconsent at 12 month follow-up)
has previously had H3 services in the past year
can not speak English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie Zima, MD, MPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miles Square Health Center, Englewood
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60621
Country
United States
Facility Name
Erie Family Health Center, West Town
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31012861
Citation
McCreary M, Arevian AC, Brady M, Mosqueda Chichits AE, Zhang L, Tang L, Zima B. A Clinical Care Monitoring and Data Collection Tool (H3 Tracker) to Assess Uptake and Engagement in Mental Health Care Services in a Community-Based Pediatric Integrated Care Model: Longitudinal Cohort Study. JMIR Ment Health. 2019 Apr 23;6(4):e12358. doi: 10.2196/12358.
Results Reference
derived
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H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation
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