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

Not Applicable

Completed

• Conditions: Attention Deficit/Hyperactivity Disorder
• Interventions: Behavioral: Traditional Collaborative Care; Behavioral: Collaborative Care Plus

• Registration Number: NCT01275378
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Collaborative Care	Traditional Collaborative Care	Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
Collaborative Care Plus	Collaborative Care Plus	Collaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure

Primary Outcome Measures

Name	Time	Method
ADHD Symptoms	12 mo	Swanson, Nolan and Pelham scale (SNAP-IV)
Patient Medication Adherence	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 Outcome Measures

Name	Time	Method
ODD Symptoms	12 mo	SNAP-IV
Social Skills	12 mo	Social Skills Rating System
Time to Symptom Improvement	12 mo	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

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States