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Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01275378
First Posted: January 12, 2011
Last Update Posted: October 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Codman Square Health Center
Dorchester House Health Center
Information provided by (Responsible Party):
Michael Silverstein, Boston Medical Center
  Purpose
The purpose of this study is to compare the effectiveness of two care models on ADHD outcomes: one, a model of basic care management and structured communication with specialists, consistent with conventional descriptions of a patient-centered Medical Home; and another, which combines the Medical Home with theory-based care management strategies to address common reasons for ADHD treatment failure.

Condition Intervention
Attention Deficit/Hyperactivity Disorder Behavioral: Collaborative Care Plus Behavioral: Traditional Collaborative Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: COMPARATIVE EFFECTIVENESS RESEARCH FOR TWO MEDICAL HOME MODELS FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER

Resource links provided by NLM:


Further study details as provided by Michael Silverstein, Boston Medical Center:

Primary Outcome Measures:
  • ADHD Symptoms [ Time Frame: 6 mo ]
    Swanson, Nolan and Pelham scale (SNAP-IV)

  • ADHD Symptoms [ Time Frame: 12 mo ]
    Swanson, Nolan and Pelham scale (SNAP-IV)

  • Patient Medication Adherence [ Time Frame: 6 mo ]
    Timely prescribed refills of ADHD medications - assessed through the EHR - will provide an accurate picture of medication adherence from the perspective of prescription writing. In addition, we will administer the validated Medication Adherence Scale, which has good reliability among parents of urban children with asthma

  • Patient Medication Adherence [ Time Frame: 12 mo ]
    Timely prescribed refills of ADHD medications - assessed through the EHR - will provide an accurate picture of medication adherence from the perspective of prescription writing. In addition, we will administer the validated Medication Adherence Scale, which has good reliability among parents of urban children with asthma


Secondary Outcome Measures:
  • ODD Symptoms [ Time Frame: 6 mo ]
    SNAP-IV

  • Social Skills [ Time Frame: 6 mo ]
    Social Skills Rating System

  • Time to Symptom Improvement [ Time Frame: 12 mo ]
    Based on follow-up ADHD symptom scales administered at regular intervals by our care managers, we will quantify the time between initial diagnosis and definitive improvement - conventionally defined by a 25% symptom reduction from baseline

  • ODD Symptoms [ Time Frame: 12 mo ]
    SNAP-IV

  • Social Skills [ Time Frame: 12 mo ]
    Social Skills Rating System


Estimated Enrollment: 156
Study Start Date: October 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Collaborative Care Plus
Collaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure
Behavioral: Collaborative Care Plus
Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans
Active Comparator: Traditional Collaborative Care
Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
Behavioral: Traditional Collaborative Care
Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child is being evaluated for a potential diagnosis of ADHD by a primary care pediatrician at one of our sites.
  • Child is 6 to 12 years of age
  • Family plans to remain in the Boston area for the duration of the follow-up period
  • Mother is comfortable in English or Spanish

Exclusion Criteria:

  • Child already has a confirmed diagnosis of ADHD
  • Child already receives ongoing specialty care in one or more of the following clinics: pediatric psychiatry, developmental behavioral pediatrics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275378


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Codman Square Health Center
Dorchester House Health Center
Investigators
Principal Investigator: Michael Silverstein, MD, MPH Boston Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Silverstein, Associate Professor of Pediatrics, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01275378     History of Changes
Other Study ID Numbers: R40MC17181
First Submitted: October 11, 2010
First Posted: January 12, 2011
Last Update Posted: October 10, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms