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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 156
Study Start Date: October 2010
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275378

Contacts
Contact: Michael Silverstein, M.D & MPH 617 414 7903 michael.silverstein@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Micheal Silverstein, MD, MPH            
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

No publications provided

Responsible Party: Michael Silverstein, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01275378     History of Changes
Other Study ID Numbers: R40MC17181
Study First Received: October 11, 2010
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 18, 2012