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H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation (H3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699814
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Bonnie Zima, MD MPH, University of California, Los Angeles

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.


Condition or disease Intervention/treatment Phase
Developmental Delay Mental Health Disorder Behavioral: H3 Services Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation
Actual Study Start Date : March 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: H3 Parent/Child Dyads
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.
Behavioral: H3 Services
A community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems




Primary Outcome Measures :
  1. H3 intervention care processes [ Time Frame: 12 months ]
    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 :
  1. Mental health functioning [ Time Frame: Baseline, 3, 6 and 12 months ]
    PHQ9

  2. Child development [ Time Frame: 12 monthsBaseline, 3, 6 and 12 months ]
    Pediatric Symptom Checklist

  3. Child functioning [ Time Frame: Baseline, 3, 6 and 12 months ]
    Columbia Impairment Scale

  4. Response to trauma and resilience [ Time Frame: Baseline, 3, 6 and 12 months ]
    Traumatic Events Screening Inventory

  5. Care process delivered [ Time Frame: Baseline, 3, 6 and 12 months ]
    Questionnaire administered at baseline, 3, 6, and 12 months asking parent and child about any care processes that he/she received.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699814


Locations
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United States, Illinois
Miles Square Health Center, Englewood
Chicago, Illinois, United States, 60621
Erie Family Health Center, West Town
Chicago, Illinois, United States, 60622
Sponsors and Collaborators
University of California, Los Angeles
University of Illinois at Chicago
Investigators
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Principal Investigator: Bonnie Zima, MD, MPH University of California, Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bonnie Zima, MD MPH, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02699814    
Other Study ID Numbers: IRB#15-000757
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Keywords provided by Bonnie Zima, MD MPH, University of California, Los Angeles:
Depression
Children
Anxiety
Additional relevant MeSH terms:
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Mental Disorders