Developmental DelayH3NCT02699814
H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation
A study testing H3 Services in people with Developmental Delay and Mental Health Disorder, run by University of California, Los Angeles at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Developmental Delay, Mental Health Disorder
- What is being tested?
- H3 Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2016to 31 Mar 2019
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Miles Square Health Center, Englewood
Chicago, Illinois, 60621
Erie Family Health Center, West Town
Chicago, Illinois, 60622
About this study
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.
Read the 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.
- Conditions
- Developmental Delay, Mental Health Disorder
- Being tested
- H3 Services
- Keywords
- Depression, Children, Anxiety
- Medical subject headings
- Learning Disabilities, Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H3 ServicesBehavioural
A community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: H3 Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 12 months
Secondary outcomes (5)
Mental health functioning
PHQ9
Measured: Baseline, 3, 6 and 12 months
Child development
Pediatric Symptom Checklist
Measured: 12 monthsBaseline, 3, 6 and 12 months
Child functioning
Columbia Impairment Scale
Measured: Baseline, 3, 6 and 12 months
Response to trauma and resilience
Traumatic Events Screening Inventory
Measured: Baseline, 3, 6 and 12 months
Care process delivered
Questionnaire administered at baseline, 3, 6, and 12 months asking parent and child about any care processes that he/she received.
Measured: Baseline, 3, 6 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 posted4 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Principal investigator, Bonnie Zima, MD MPH, University of California, Los Angeles
- Investigators
- Bonnie Zima, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699814
- Sponsor's protocol ID
- IRB#15-000757
- Acronym
- H3
- Status last verified
- Sep 2019
- First submitted
- 25 Jan 2016
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31012861
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H3: Healthy Minds, Healthy Children, Healthy Chicago Project Evaluation
- ClinicalTrials.gov ID
- NCT02699814
- Acronym / sponsor ID
- H3 / IRB#15-000757
- Conditions
- Developmental Delay, Mental Health Disorder
- Keywords
- Depression, Children, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 4 Mar 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H3 Parent/Child Dyads | Experimental | Behavioral: H3 ServicesA 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. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| H3 ServicesA community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems | Behavioural | H3 Parent/Child Dyads |
Primary outcome
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"
5 secondary outcomes
Mental health functioning
Time frame: Baseline, 3, 6 and 12 months
Child development
Time frame: 12 monthsBaseline, 3, 6 and 12 months
Child functioning
Time frame: Baseline, 3, 6 and 12 months
Response to trauma and resilience
Time frame: Baseline, 3, 6 and 12 months
Care process delivered
Time frame: Baseline, 3, 6 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 30 Sep 2019.
- Derived from this study: PubMed 31012861McCreary 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.
Related trials for Developmental Delay
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Recruiting
A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Development Disorder, Child, Developmental Disability
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
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.
Bonnie Zima, MD, MPH principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H3 Services in people with Developmental Delay and Mental Health Disorder, run by University of California, Los Angeles at 2 sites 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 5 inclusion and 3 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
H3 intervention care processes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02699814, which also lists 1 linked publication.
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 30 Sep 2019.