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

This study is currently recruiting participants.
Verified October 2010 by Boston Medical Center
Sponsor:
Collaborators:
Codman Square Health Center
Dorchester House Health Center
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01275378
First received: October 11, 2010
Last updated: February 23, 2012
Last verified: October 2010

October 11, 2010
February 23, 2012
October 2010
September 2013   (final data collection date for primary outcome measure)
  • ADHD Symptoms [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
    Swanson, Nolan and Pelham scale (SNAP-IV)
  • ADHD Symptoms [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
    Swanson, Nolan and Pelham scale (SNAP-IV)
  • Patient Medication Adherence [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT01275378 on ClinicalTrials.gov Archive Site
  • ODD Symptoms [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
    SNAP-IV
  • Social Skills [ Time Frame: 6 mo ] [ Designated as safety issue: No ]
    Social Skills Rating System
  • Time to Symptom Improvement [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    SNAP-IV
  • Social Skills [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
    Social Skills Rating System
Same as current
Not Provided
Not Provided
 
Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder
COMPARATIVE EFFECTIVENESS RESEARCH FOR TWO MEDICAL HOME MODELS FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Attention Deficit/Hyperactivity Disorder
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
156
Not Provided
September 2013   (final data collection date for primary outcome measure)

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
Both
6 Years to 12 Years
Yes
Contact: Michael Silverstein, M.D & MPH 617 414 7903 michael.silverstein@bmc.org
United States
 
NCT01275378
R40MC17181
No
Michael Silverstein, Boston Medical Center
Boston Medical Center
  • Codman Square Health Center
  • Dorchester House Health Center
Principal Investigator: Michael Silverstein, MD, MPH Boston Medical Center
Boston Medical Center
October 2010

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