NCT01275378

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

3.7 years

First QC Date

October 11, 2010

Last Update Submit

October 7, 2016

Conditions

Attention Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • ODD Symptoms

    6 mo

  • Social Skills

    6 mo

  • Time to Symptom Improvement

    12 mo

  • ODD Symptoms

    12 mo

  • Social Skills

    12 mo

Study Arms (2)

Collaborative Care Plus

ACTIVE COMPARATOR

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

Behavioral: Collaborative Care Plus

Traditional Collaborative Care

ACTIVE COMPARATOR

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

Behavioral: Traditional Collaborative Care

Interventions

Collaborative Care PlusBEHAVIORAL

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

Collaborative Care Plus
Traditional Collaborative CareBEHAVIORAL

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

Traditional Collaborative Care

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

    PMID: 25802346DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Michael Silverstein, MD, MPH

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

October 11, 2010

First Posted

January 12, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations

US(1)