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

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

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 Overview

• Status: Completed
• Conditions: Attention Deficit/Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Collaborative Care Plus; Behavioral: Traditional Collaborative Care

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Codman Square Health Center; Dorchester House Health Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: October 11, 2010
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (ESTIMATE): January 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: R40MC17181