- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644566
Pilot Study of Shared Care of ADHD in a Pediatric Clinic:Colocation of a Psychologist as an ADHD Care Manager (shared care)
Study Overview
Detailed Description
Study Goals:
A. To compare patients with ADHD (Attention Deficit Hyperactivity Disorder) treated by a pediatric provider in collaboration with a co-located psychologist/ADHD care manager available for evaluation/assessment and ongoing shared-care consultation to patients with ADHD in a pediatric primary care clinic treated as usual.
Patients treated by the pediatricians with the added co-located services will have clinical outcomes that are superior to those that receive usual care
- Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services
- A higher proportion of patients treated by the pediatric providers and psychologists than those in usual care receive doses of medication that are consistent with AAP (American Academy of Pediatrics) recommendations
- Patients whose providers are offered to receive the aid of the co-located psychologists will be more likely to be co-managed by the pediatrician than referred out to the community.
- Parents will be more satisfied with care in the shared care model than in usual care
B. Pediatricians' morale and attitudes to the treatment of ADHD will improve with the addition of a co-located psychologist.
C. ADDITIONAL AIMS:
- To assist a pediatric primary care clinic in implementing a quality improvement initiative to help pediatric providers better identify ADHD by implementing the PSC-17, a general psychosocial checklist.
- Study the usefulness of using the PSC 17 screen as a clinical tool to identify ADHD in the primary care office by obtaining results and tracking physician disposition planning based on results.
D. Operationalize Shared Care by examining what happens in such an arrangement, and see if patient recruitment and provider buy-in improves when shared care is assured.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rachel A Zuckerbrot, MD
- Phone Number: 212-543-2628
- Email: zuckerbr@childpsych.columbia.edu
Study Locations
-
-
New York
-
Long Island City, New York, United States, 11106
- Active, not recruiting
- Long Island City Community Practice
-
New York, New York, United States, 10021
- Recruiting
- New York Presbyterina Hospital- Weill Cornell Medcial College HT5 Pediatrics Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (Patient subjects):
- Age 6-17
- Suspected diagnosis of ADHD, inattentive type, hyperactive type, combined type, NOS
- Living with Guardian for at least 6 months
- English-speaking child
- English-speaking guardian
- Telephone Access to Guardian
- Inclusion for Randomization or Phase 2 shared care:
- Diagnosis of ADHD
Exclusion Criteria:
- Mental Retardation
- Co-morbid psychotic disorder
- Suicidal
- Homicidal
- Dangerous behavior
- Foster care
- Impairing co-morbid psychiatric disorder that would make ADHD treatment in a pediatric clinic unsafe or inappropriate (in the judgment of the PI based on the case review of the findings of the clinical psychologist.)
- Allergic or contraindication to stimulant medications
Inclusion Criteria (Provider subjects):
- Provider at Cornell Campus Helmsley Tower 5/ Long Island City Campus
Exclusion Criteria:
- None
Inclusion for screening:
- Age 6-17
- Child is to be seen by pediatric provider at HT5
- Parent or guardian reads English or Spanish
Exclusion Criteria:
- Parent/Guardian has received screen within the year
- Patient is too sick for parent to spend time on form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: TAU
Treatment as usual.
These subjects and their providers were told to pursue treatment services as they normally would do.
|
|
EXPERIMENTAL: shared care
A psychologist co-located in the pediatric primary care clinic shared care with the subject's pediatrician.
The psychologist offered regular appointments and psychoeducation.
On an individual basis, parent management training, behavioral management training, individual psychotherapy, educational intervention assistance, teacher communication, and medication education were provided as needed.
|
A psychologist co-located in the pediatric primary care clinic shared care with the subject's pediatrician.
The psychologist offered regular appointments and psychoeducation.
On an individual basis, parent management training, behavioral management training, individual psychotherapy, educational intervention assistance, teacher communication, and medication education were provided as needed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A higher proportion of patients treated by the pediatric providers and psychologists than those in usual care receive doses of medication that are consistent with AAP (American Academy of Pediatrics) recommendations
Time Frame: six months
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services
Time Frame: six months
|
six months
|
2. Patients whose providers are offered to receive the aid of the co-located psychologists will be more likely to be co-managed by the pediatrician than referred out to the community.
Time Frame: six months
|
six months
|
Parents will be more satisfied with care in the shared care model than in usual care
Time Frame: six months
|
six months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Daniel Hyman, MD, New York Presbyterian Hospital
- Principal Investigator: Rachel Zuckerbrot, MD, Columbia University/New York State Psychiatric Institute
- Principal Investigator: Mark Olfson, MD, Columbia University/New York State Psychiatric Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0604008460
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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