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

Mental Health Disorder Clinical Trial

— H3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699814
• Other study ID #: IRB#15-000757
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: September 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: March 31, 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay
• Mental Disorders
• Mental Health Disorder

Intervention

Behavioral:
• H3 Services
A community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems

Locations

Country	Name	City	State
United States	Erie Family Health Center, West Town	Chicago	Illinois
United States	Miles Square Health Center, Englewood	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	12 months
Secondary	Mental health functioning	PHQ9	Baseline, 3, 6 and 12 months
Secondary	Child development	Pediatric Symptom Checklist	12 monthsBaseline, 3, 6 and 12 months
Secondary	Child functioning	Columbia Impairment Scale	Baseline, 3, 6 and 12 months
Secondary	Response to trauma and resilience	Traumatic Events Screening Inventory	Baseline, 3, 6 and 12 months
Secondary	Care process delivered	Questionnaire administered at baseline, 3, 6, and 12 months asking parent and child about any care processes that he/she received.	Baseline, 3, 6 and 12 months