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

NCT ID: NCT01275378

Last Updated: 2016-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Attention Deficit/Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Collaborative Care Plus

Collaborative care model with specific theory-based elements to address common reasons for ADHD treatment failure

Group Type ACTIVE_COMPARATOR

Collaborative Care Plus

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Traditional Collaborative Care

Intervention Type BEHAVIORAL

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

Interventions

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Collaborative Care Plus

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

Intervention Type BEHAVIORAL

Traditional Collaborative Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Codman Square Health Center

UNKNOWN

Sponsor Role collaborator

Dorchester House Health Center

UNKNOWN

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Silverstein

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Silverstein, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25802346 (View on PubMed)

Other Identifiers

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R40MC17181

Identifier Type: -

Identifier Source: org_study_id

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