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Completed

NCT Number: NCT01275378

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.

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Key information

Conditions

Attention Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collaborative Care Plus

Behavioral

Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans

Traditional Collaborative Care

Behavioral

Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists

Primary outcomes

  1. ADHD Symptoms

    Time frame: 6 mo

    Swanson, Nolan and Pelham scale (SNAP-IV)

  2. ADHD Symptoms

    Time frame: 12 mo

    Swanson, Nolan and Pelham scale (SNAP-IV)

  3. Patient Medication Adherence

    Time frame: 6 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

  4. Patient Medication Adherence

    Time frame: 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 outcomes

  1. ODD Symptoms

    Time frame: 6 mo

    SNAP-IV

  2. Social Skills

    Time frame: 6 mo

    Social Skills Rating System

  3. Time to Symptom Improvement

    Time frame: 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

  4. ODD Symptoms

    Time frame: 12 mo

    SNAP-IV

  5. Social Skills

    Time frame: 12 mo

    Social Skills Rating System

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Codman Square Health Center
  • Dorchester House Health Center

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 12, 2011
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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