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

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.
 
ClinicalTrials.gov Identifier: NCT01275378
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : October 10, 2016
Sponsor:
Collaborators:
Codman Square Health Center
Dorchester House Health Center
Information provided by (Responsible Party):
Michael Silverstein, Boston Medical Center

Tracking Information
First Submitted Date  ICMJE October 11, 2010
First Posted Date  ICMJE January 12, 2011
Last Update Posted Date October 10, 2016
Study Start Date  ICMJE October 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2011)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder
Official Title  ICMJE COMPARATIVE EFFECTIVENESS RESEARCH FOR TWO MEDICAL HOME MODELS FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Attention Deficit/Hyperactivity Disorder
Intervention  ICMJE
  • Behavioral: Collaborative Care Plus
    Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans
  • Behavioral: Traditional Collaborative Care
    Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
Study Arms  ICMJE
  • Active Comparator: Collaborative Care Plus
    Collaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure
    Intervention: Behavioral: Collaborative Care Plus
  • Active Comparator: Traditional Collaborative Care
    Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
    Intervention: Behavioral: Traditional Collaborative Care
Publications * Silverstein M, Hironaka LK, Walter HJ, Feinberg E, Sandler J, Pellicer M, Chen N, Cabral H. Collaborative care for children with ADHD symptoms: a randomized comparative effectiveness trial. Pediatrics. 2015 Apr;135(4):e858-67. doi: 10.1542/peds.2014-3221.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 11, 2011)		 156
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01275378
Other Study ID Numbers  ICMJE R40MC17181
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Michael Silverstein, Boston Medical Center
Original Responsible Party Michael Silverstein, Boston Medical Center
Current Study Sponsor  ICMJE Boston Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Codman Square Health Center
  • Dorchester House Health Center
Investigators  ICMJE
Principal Investigator: Michael Silverstein, MD, MPH Boston Medical Center
PRS Account Boston Medical Center
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP