NCT00644566

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

August 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 5, 2010

Status Verified

November 1, 2010

Enrollment Period

1.8 years

First QC Date

March 19, 2008

Last Update Submit

November 4, 2010

Conditions

Keywords

ADHDPrimary CarePediatricsHealth servicesshared carecare managerscreening

Outcome Measures

Primary Outcomes (1)

  • 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

    six months

Secondary Outcomes (3)

  • Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services

    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.

    six months

  • Parents will be more satisfied with care in the shared care model than in usual care

    six months

Study Arms (2)

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.

Other: Shared Care

Interventions

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.

shared care

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Diagnosis of ADHD

You may not qualify if:

  • 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
  • Provider at Cornell Campus Helmsley Tower 5/ Long Island City Campus
  • None
  • Age 6-17
  • Child is to be seen by pediatric provider at HT5
  • Parent or guardian reads English or Spanish
  • Parent/Guardian has received screen within the year
  • Patient is too sick for parent to spend time on form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Long Island City Community Practice

Long Island City, New York, 11106, United States

ACTIVE NOT RECRUITING

New York Presbyterina Hospital- Weill Cornell Medcial College HT5 Pediatrics Clinic

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel A Zuckerbrot, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 27, 2008

Study Start

August 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 5, 2010

Record last verified: 2010-11

Locations