ADHDshared careNCT00644566
Pilot Study of Shared Care of ADHD in a Pediatric Clinic:Colocation of a Psychologist as an ADHD Care Manager
A study testing Shared Care in people with ADHD, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
Due to the shortage of child psychiatrists and the high prevalence of child mental health disorder, pediatricians and other pediatric primary care providers often assume responsibility for the management of various psychiatric disorders, including ADHD, Attention Deficit Hyperactivity Disorder. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Shared Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Jun 2008
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 11Show fewer
- Diagnosis of ADHD
- Provider at Cornell Campus Helmsley Tower 5/ Long Island City Campus
- Age 6-17
- Child is to be seen by pediatric provider at HT5
- Parent or guardian reads English or Spanish
Who cannot join
- Mental Retardation
- Co-morbid psychotic disorder
- Suicidal
- Homicidal
- Dangerous behavior
- Foster care
Show all 11Show fewer
- 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
- None
- Parent/Guardian has received screen within the year
- Patient is too sick for parent to spend time on form
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Active, not recruiting
Long Island City Community Practice
Long Island City, New York, 11106
- Recruiting
New York Presbyterina Hospital- Weill Cornell Medcial College HT5 Pediatrics Clinic
New York, New York, 10021
About this study
Due to the shortage of child psychiatrists and the high prevalence of child mental health disorder, pediatricians and other pediatric primary care providers often assume responsibility for the management of various psychiatric disorders, including ADHD, Attention Deficit Hyperactivity Disorder. However, pediatricians have not been well-trained during residency to deal with the complexities of ADHD management. In addition, the system of care under which pediatricians practice do not afford the time availability that is required to properly manage a child with ADHD. On the other hand, if a pediatrician wishes to refer a patient to a child mental health specialist, many obstacles, including but not limited to stigma, insurance issues, and long waiting lists, often interfere with the patient actually receiving services for his/her ADHD. This research project seeks to examine an innovative model of care in which a child psychologist is located on the premises of a pediatric office and is available to share the care of patients with the pediatrician in order to address ADHD. We hypothesize that parents as well as pediatricians will be more satisfied with this model of care and that patients will ultimately have better outcomes. The beginning of our pilot has shown under-identification to be a barrier to care as well, and thus we propose to implement a quality improvement initiative to screen children for psychosocial issues as well. As we have had trouble with recruitment and unfortunately have had more children randomized to TAU than shared care, we propose in December 2007 a phase 2 of our study where all subjects, instead of randomization, are entered into shared care.
Read the detailed description
Study Goals:
- 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
- Pediatricians' morale and attitudes to the treatment of ADHD will improve with the addition of a co-located psychologist.
- 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.
- 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.
- Conditions
- ADHD
- Being tested
- Shared Care
- Keywords
- ADHD, Primary Care, Pediatrics, Health services, shared care, care manager, screening
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TAU | No intervention | Treatment as usual. These subjects and their providers were told to pursue treatment services as they normally would do. |
| shared care | Experimental | 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. Receives: Other: Shared Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months
Secondary outcomes (3)
Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services
Measured: 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.
Measured: six months
Parents will be more satisfied with care in the shared care model than in usual care
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startAug 2006
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), New York State Psychiatric Institute, Research Foundation for Mental Hygiene, Inc., Columbia University
- Investigators
- Daniel Hyman, MD, Principal investigator, New York Presbyterian HospitalRachel Zuckerbrot, MD, Principal investigator, Columbia University/New York State Psychiatric InstituteMark Olfson, MD, Principal investigator, Columbia University/New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644566
- Sponsor's protocol ID
- 0604008460
- Acronym
- shared care
- Status last verified
- Nov 2010
- First submitted
- 19 Mar 2008
- Last updated
- 5 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Shared Care of ADHD in a Pediatric Clinic:Colocation of a Psychologist as an ADHD Care Manager
- ClinicalTrials.gov ID
- NCT00644566
- Acronym / sponsor ID
- shared care / 0604008460
- Conditions
- ADHD
- Keywords
- ADHD, Primary Care, Pediatrics, Health services, shared care, care manager, screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), New York State Psychiatric Institute, Research Foundation for Mental Hygiene, Inc., Columbia University
- Study start
- Aug 2006
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 27 Mar 2008 (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.
Due to the shortage of child psychiatrists and the high prevalence of child mental health disorder, pediatricians and other pediatric primary care providers often assume responsibility for the management of various psychiatric disorders, including ADHD, Attention Deficit Hyperactivity Disorder. However, pediatricians have not been well-trained during residency to deal with the complexities of ADHD management. In addition, the system of care under which pediatricians practice do not afford the time availability that is required to properly manage a child with ADHD. On the other hand, if a pediatrician wishes to refer a patient to a child mental health specialist, many obstacles, including but not limited to stigma, insurance issues, and long waiting lists, often interfere with the patient actually receiving services for his/her ADHD. This research project seeks to examine an innovative model of care in which a child psychologist is located on the premises of a pediatric office and is available to share the care of patients with the pediatrician in order to address ADHD. We hypothesize that parents as well as pediatricians will be more satisfied with this model of care and that patients will ultimately have better outcomes. The beginning of our pilot has shown under-identification to be a barrier to care as well, and thus we propose to implement a quality improvement initiative to screen children for psychosocial issues as well. As we have had trouble with recruitment and unfortunately have had more children randomized to TAU than shared care, we propose in December 2007 a phase 2 of our study where all subjects, instead of randomization, are entered into shared care.
Detailed description
Study Goals:
- 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
- Pediatricians' morale and attitudes to the treatment of ADHD will improve with the addition of a co-located psychologist.
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU | No intervention | –Treatment as usual. These subjects and their providers were told to pursue treatment services as they normally would do. |
| shared care | Experimental | Other: Shared CareA 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- Mental Retardation
- Co-morbid psychotic disorder
- Suicidal
- Homicidal
- Dangerous behavior
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 |
|---|---|---|
| Shared CareA 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. | Other | shared care |
Primary outcome
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
3 secondary outcomes
Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services
Time frame: 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
Parents will be more satisfied with care in the shared care model than in usual care
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2010.
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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.
Daniel Hyman, MD principal investigator
New York Presbyterian Hospital
Rachel Zuckerbrot, MD principal investigator
Columbia University/New York State Psychiatric Institute
Mark Olfson, MD principal investigator
Columbia University/New York State Psychiatric Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Care in people with ADHD, run by Weill Medical College of Cornell University 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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 5 Nov 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel A Zuckerbrot, MD (212-543-2628, zuckerbr@childpsych.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2010.