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Clinical Trials/NCT01275378
NCT01275378
Completed
Not Applicable

COMPARATIVE EFFECTIVENESS RESEARCH FOR TWO MEDICAL HOME MODELS FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER

Boston Medical Center1 site in 1 country156 target enrollmentStarted: October 2010Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
156
Locations
1
Primary Endpoint
ADHD Symptoms

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
6 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

ADHD Symptoms

Time Frame: 12 mo

Swanson, Nolan and Pelham scale (SNAP-IV)

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 Outcomes

  • ODD Symptoms(12 mo)
  • Social Skills(12 mo)
  • Time to Symptom Improvement(12 mo)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Silverstein

Associate Professor of Pediatrics

Boston Medical Center

Study Sites (1)

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