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NCT01143701 · ClinicalTrials.gov registry record · Phase 4
Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care
A Phase 4 study of ADHD, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 577
- Enrollment target
- 1
- Study location
NCT01143701 is a Phase 4 study of ADHD that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 577 participants, above the 183-participant average among 75 other ADHD trials with a reported enrollment target (215% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01143701, a Phase 4 study of ADHD, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 577 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- OTHER ADHD Collaborative
Study Locations (1)
Ohio
- Nationwide Childrens Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 577 participants |
| Start Date | 2010-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01143701
The ClinicalTrials.gov registry entry for NCT01143701 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 577 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 183-participant average among 75 other ADHD trials with a reported enrollment target (215% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with ADHD appearing as the primary indexed condition, and to 1 intervention - of which ADHD Collaborative is the first listed.
NCT01143701 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT01143701 about?
NCT01143701 is a clinical study titled "Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care". 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 ad...
What is the current status of trial NCT01143701?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 577 participants. The study started on 2010-05. Estimated completion is 2016-06.
What conditions does trial NCT01143701 study?
This clinical trial studies the following conditions: ADHD.
What interventions are being tested in trial NCT01143701?
The interventions under investigation include: ADHD Collaborative (OTHER).
Who is sponsoring clinical trial NCT01143701?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01143701 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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