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

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275378
• Other study ID #: R40MC17181
• Status: Completed
• Phase: N/A
• First received: October 11, 2010
• Last updated: October 7, 2016
• Start date: October 2010
• Est. completion date: June 2014

Study information

• Verified date: October 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Behavioral:
• Collaborative Care Plus
Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans
• Traditional Collaborative Care
Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	Codman Square Health Center, Dorchester House Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD Symptoms	Swanson, Nolan and Pelham scale (SNAP-IV)	6 mo	No
Primary	ADHD Symptoms	Swanson, Nolan and Pelham scale (SNAP-IV)	12 mo	No
Primary	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	No
Primary	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	No
Secondary	ODD Symptoms	SNAP-IV	6 mo	No
Secondary	Social Skills	Social Skills Rating System	6 mo	No
Secondary	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	No
Secondary	ODD Symptoms	SNAP-IV	12 mo	No
Secondary	Social Skills	Social Skills Rating System	12 mo	No