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Disseminating a Model Intervention to Promote Improved Attention-deficit Hyperactivity Disorder (ADHD) Care in the Community

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ClinicalTrials.gov Identifier: NCT01056016
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jeff Epstein, Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Attention Deficit Hyperactivity Disorder
Intervention Other: ADHD Collaborative
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wait-list Control ADHD Collaborative Intervention
Hide Arm/Group Description Wait-list control group

This intervention includes mapping and redesign of office flow to facilitate adherence to American Academy of Pediatrics (AAP) ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics include the importance of obtaining parent and teacher behavioral ratings at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.

ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial

Period Title: Overall Study
Started 22 [1] 27 [2]
Completed 20 26
Not Completed 2 1
[1]
22 pediatricians were at 4 practices; practices were unit of randomization
[2]
27 pediatricians were at 4 practices; practices were unit of randomization
Arm/Group Title Wait-list Control ADHD Collaborative Intervention Total
Hide Arm/Group Description Wait-list control group

This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.

ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial

Total of all reporting groups
Overall Number of Baseline Participants 22 27 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 27 participants 49 participants
47.0  (10.3) 46.6  (11.3) 46.8  (10.7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 27 participants 49 participants
Female
15
  68.2%
14
  51.9%
29
  59.2%
Male
7
  31.8%
13
  48.1%
20
  40.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 27 participants 49 participants
22 27 49
1.Primary Outcome
Title Physician ADHD Practice Behavior
Hide Description Percentage of patients across pediatricians in each randomized group for whom the pediatrician collected teacher ratings to monitor treatment response
Time Frame Baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patient chart reviews were conducted with 174 patients in the ADHD Collaborative Intervention group and 64 patients in the Wait-list control group
Arm/Group Title Wait-list Control ADHD Collaborative Intervention
Hide Arm/Group Description:
Wait-list control group

This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.

ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial

Overall Number of Participants Analyzed 22 27
Mean (Standard Deviation)
Unit of Measure: percentage of patients
Baseline 0  (0) 0  (0)
6-months 6.3  (25.0) 38.7  (36.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wait-list Control, ADHD Collaborative Intervention
Comments The percentage of patients with whom pediatrician in each group utilized each practice behavior at baseline and 6-months was computed. The reported statistical analysis did not account potential clustering due to the small number of practices in this study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 32.4
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Participants in each Arm/Group were not monitored for adverse events.
 
Arm/Group Title Wait-list Control ADHD Collaborative Intervention
Hide Arm/Group Description Wait-list control group

This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.

ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial

All-Cause Mortality
Wait-list Control ADHD Collaborative Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Wait-list Control ADHD Collaborative Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Wait-list Control ADHD Collaborative Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jeff Epstein, Ph.D.
Organization: Cincinnati Children's Hospital Medical Center
Phone: 5136368296
Responsible Party: Jeff Epstein, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01056016     History of Changes
Other Study ID Numbers: R21MH082714 ( U.S. NIH Grant/Contract )
First Submitted: January 22, 2010
First Posted: January 26, 2010
Results First Submitted: July 25, 2016
Results First Posted: December 23, 2016
Last Update Posted: December 23, 2016