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

Study Overview
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Brief Summary
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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.

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

Conditions
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Attention Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Collaborative Care Plus
* Behavioral: Traditional Collaborative Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collaborative Care Plus<br>Collaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure | Behavioral: Collaborative Care Plus<br>* Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans<br>|
| Active Comparator: Traditional Collaborative Care<br>Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists | Behavioral: Traditional Collaborative Care<br>* Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD Symptoms | Swanson, Nolan and Pelham scale (SNAP-IV) | 6 mo | 
| ADHD Symptoms | Swanson, Nolan and Pelham scale (SNAP-IV) | 12 mo | 
| 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 | 6 mo | 
| 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 | 12 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODD Symptoms | SNAP-IV | 6 mo | 
| Social Skills | Social Skills Rating System | 6 mo | 
| 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 | 12 mo | 
| ODD Symptoms | SNAP-IV | 12 mo | 
| Social Skills | Social Skills Rating System | 12 mo |