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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01275378
Other study ID # R40MC17181
Secondary ID
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
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