Back to resultsComparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder
Primary Purpose
Attention Deficit/Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care Plus
Traditional Collaborative Care
Sponsored by
About this trial
This is an interventional health services research trial for Attention Deficit/Hyperactivity Disorder
Eligibility 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
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Collaborative Care Plus
Traditional Collaborative Care
Arm Description
Collaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure
Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
Outcomes
Primary Outcome Measures
ADHD Symptoms
Swanson, Nolan and Pelham scale (SNAP-IV)
ADHD Symptoms
Swanson, Nolan and Pelham scale (SNAP-IV)
Patient Medication Adherence
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
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
SNAP-IV
Social Skills
Social Skills Rating System
Time to Symptom Improvement
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
SNAP-IV
Social Skills
Social Skills Rating System
Full Information
NCT ID
NCT01275378
First Posted
October 11, 2010
Last Updated
October 7, 2016
Sponsor
Boston Medical Center
Collaborators
Codman Square Health Center, Dorchester House Health Center
1. Study Identification
Unique Protocol Identification Number
NCT01275378
Brief Title
Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder
Official Title
COMPARATIVE EFFECTIVENESS RESEARCH FOR TWO MEDICAL HOME MODELS FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
Codman Square Health Center, Dorchester House Health Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collaborative Care Plus
Arm Type
Active Comparator
Arm Description
Collaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure
Arm Title
Traditional Collaborative Care
Arm Type
Active Comparator
Arm Description
Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care Plus
Intervention Description
Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans
Intervention Type
Behavioral
Intervention Name(s)
Traditional Collaborative Care
Intervention Description
Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
Primary Outcome Measure Information:
Title
ADHD Symptoms
Description
Swanson, Nolan and Pelham scale (SNAP-IV)
Time Frame
6 mo
Title
ADHD Symptoms
Description
Swanson, Nolan and Pelham scale (SNAP-IV)
Time Frame
12 mo
Title
Patient Medication Adherence
Description
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
Time Frame
6 mo
Title
Patient Medication Adherence
Description
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
Time Frame
12 mo
Secondary Outcome Measure Information:
Title
ODD Symptoms
Description
SNAP-IV
Time Frame
6 mo
Title
Social Skills
Description
Social Skills Rating System
Time Frame
6 mo
Title
Time to Symptom Improvement
Description
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
Time Frame
12 mo
Title
ODD Symptoms
Description
SNAP-IV
Time Frame
12 mo
Title
Social Skills
Description
Social Skills Rating System
Time Frame
12 mo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Silverstein, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25802346
Citation
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.
Results Reference
derived
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Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder
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