Overview

This trial is active, not recruiting.

Condition adhd
Treatment adhd collaborative
Phase phase 4
Sponsor Children's Hospital Medical Center, Cincinnati
Collaborator Nationwide Children's Hospital
Start date May 2010
End date May 2015
Trial size 576 participants
Trial identifier NCT01143701, 1R01MH083665-01A2, MH083665

Summary

ADHD is the most prevalent mental health disorder of childhood. The majority of children with ADHD receive their care in primary care settings. While the American Academy of Pediatrics (AAP) issued evidence-based guidelines and recommendations for pediatricians, most pediatricians have difficulty adhering to these guidelines. Given observed deficiencies in evidence-based ADHD care and the likely effects on child outcomes, the development and testing of interventions aimed at improving ADHD care in primary care settings is necessary. Cincinnati Children's Hospital Medical Center has developed a model intervention, termed the ADHD Collaborative, to comprehensively address this issue. The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines. This intervention model has been used to train over 200 physicians at 55 practices in the Greater Cincinnati area. The intervention appears to produce 2- to 4-fold increases in the use of evidence-based ADHD-related practice behaviors in participating physicians. To date, the intervention has been implemented as a quality improvement project with few experimental controls. The primary goal of the proposed study is to conduct an experimentally-controlled cluster randomized trial of the ADHD Collaborative intervention. Thirty-two pediatric practices will be randomly assigned to receive the ADHD Collaborative intervention or to provide usual care. Approximately 96 physicians and 576 of their ADHD patients will be included in the study. Chart reviews, parental interviews, and parent and teacher rating scales will be collected. Between- and within-group hierarchical linear modeling analyses will examine whether the intervention produces significant improvements in pediatrician practice behaviors, patient satisfaction with ADHD care, and child outcomes over and above typical ADHD care. Also, the relative cost effectiveness of the ADHD Collaborative intervention over typical care will be established by computing incremental cost-effectiveness ratios using cost and effect size estimates.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (caregiver)
Primary purpose health services research
Arm
(Experimental)
The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.
adhd collaborative
The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines.
(No Intervention)
Physicians in this group will provide typical ADHD care.

Primary Outcomes

Measure
Parent-rated ADHD symptoms
time frame: 12 months
Teacher-rated ADHD symptoms
time frame: 12 months

Eligibility Criteria

Male or female participants from 6 years up to 11 years old.

Inclusion Criteria: - Practice must have a minimum of two pediatricians who agree to participate. - Practice must have an electronic billing system. - Practice must have internet access at office. - Practice must not have an on-site mental health professional. - Practice must have a member of practice staff willing to be trained in human subjects certification and willing to consent families. - Children must be in Grade 1-5. - Children must be newly diagnosed with ADHD. Exclusion Criteria:

Additional Information

Official title Evaluation of an Intervention for Improving Community-based Pediatric ADHD Care
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.