NCT02699814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.4 years

First QC Date

January 25, 2016

Last Update Submit

September 26, 2019

Conditions

Keywords

DepressionChildrenAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mental health functioning

    Baseline, 3, 6 and 12 months

  • Child development

    12 monthsBaseline, 3, 6 and 12 months

  • Child functioning

    Baseline, 3, 6 and 12 months

  • Response to trauma and resilience

    Baseline, 3, 6 and 12 months

  • Care process delivered

    Baseline, 3, 6 and 12 months

Study Arms (1)

H3 Parent/Child Dyads

EXPERIMENTAL

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

Interventions

H3 ServicesBEHAVIORAL

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

H3 Parent/Child Dyads

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miles Square Health Center, Englewood

Chicago, Illinois, 60621, United States

Location

Erie Family Health Center, West Town

Chicago, Illinois, 60622, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Learning DisabilitiesMental DisordersDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersBehavioral SymptomsBehavior

Study Officials

  • Bonnie Zima, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2016

First Posted

March 4, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2018

Study Completion

March 31, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations