Trial Outcomes & Findings for Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care (NCT NCT01143701)
NCT ID: NCT01143701
Last Updated: 2016-11-08
Results Overview
Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
577 participants
Primary outcome timeframe
12 months
Results posted on
2016-11-08
Participant Flow
Participant milestones
| Measure |
ADHD Collaborative Intervention
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 American Academy of Pediatrics ADHD guidelines.
|
Typical ADHD Care
Physicians in this group will provide typical ADHD care.
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
319
|
|
Overall Study
COMPLETED
|
235
|
287
|
|
Overall Study
NOT COMPLETED
|
23
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care
Baseline characteristics by cohort
| Measure |
ADHD Collaborative Intervention
n=258 Participants
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.
|
Typical ADHD Care
n=319 Participants
Physicians in this group will provide typical ADHD care.
|
Total
n=577 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.9 Years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
7.8 Years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
7.8 Years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
407 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
252 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
564 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
187 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
378 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
258 participants
n=5 Participants
|
319 participants
n=7 Participants
|
577 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.
Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.
Outcome measures
| Measure |
ADHD Collaborative Intervention
n=22 Practices Analyzed
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.
|
Typical ADHD Care
n=22 Practices Analyzed
Physicians in this group will provide typical ADHD care.
|
|---|---|---|
|
Parent-rated ADHD Symptoms
|
20.5 scores on a scale
Standard Deviation 9.0
|
24.1 scores on a scale
Standard Deviation 9.4
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analyses only included patients who had a post-intervention teacher-rated ADHD scale. Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.
Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.
Outcome measures
| Measure |
ADHD Collaborative Intervention
n=22 Practices Analyzed
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.
|
Typical ADHD Care
n=22 Practices Analyzed
Physicians in this group will provide typical ADHD care.
|
|---|---|---|
|
Teacher-rated ADHD Symptoms
|
19.0 scores on a scale
Standard Deviation 9.9
|
20.4 scores on a scale
Standard Deviation 11.1
|
Adverse Events
ADHD Collaborative Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Typical ADHD Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeff Epstein, Ph.D.
Cincinnati Children's Hospital Medical Center
Phone: 5136368296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place