- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03628781
Improving ADHD Behavioral Care
December 8, 2021 updated by: Jeff Epstein, Children's Hospital Medical Center, Cincinnati
Improving ADHD Behavioral Care Quality in Community-Based Pediatric Settings
Though the most effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD) consists of combined medication and behavioral strategies, the vast majority of children with ADHD are treated with medication only.
One reason for the low rates of behavioral treatment is that primary care pediatricians, not mental health professionals, are responsible for treating the vast majority of children with ADHD.
The investigators have developed, tested, and are beginning to disseminate web-based software (mehealth for ADHD) that has been shown in randomized clinical trials to improve the quality of ADHD medication care delivered by pediatricians.
The goal of the proposed study is to develop and test the integration of behavioral tools into the evidence-based myadhdportal.com
software in order to improve access to behavioral treatment strategies, and ultimately improve outcomes for children with ADHD.
The automated algorithms and decision rules the investigators have developed for creating and monitoring the behavioral tools ensure that behavioral treatments like daily report cards and token economies are delivered in a manner that is consistent with the evidence-base.
The investigators are conducting a cluster randomized controlled trial in community pediatric settings to test whether integration of the behavioral tools into the myADHDportal.com
software (1) increases rates of behavioral treatment; (2) facilitates better integrity of behavioral interventions when implemented; (3) improves functional impairment in children with ADHD; and (4) generates higher satisfaction with ADHD care.
By continuing to expand the functionality of the myADHDportal.com
software, the investigators are increasing patients' access to evidence-based care.
This is especially critical for rural and underserved communities who have no or limited access to evidence-based mental health services.
Moreover, by putting these behavioral tools in the hands of parents, teachers, and pediatricians, the investigators are making it more likely that children will receive a high quality of care that includes both medication management and behavioral strategies, thereby improving the overall treatment outcomes of children with ADHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
169
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45229-3026
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- child in grades K-5
- child has been diagnosed with ADHD by pediatrician or other mental health professional
- child's ADHD care is currently being managed by pediatrician
- if child is being prescribed ADHD medication, is currently on a stable dosage of medication
- child is experiencing impairment at school as evidenced by a rating of 3 or higher on parent- or teacher-ratings of "academic progress" or "problems in classroom" and on the Impairment Rating Scale.
Exclusion Criteria:
- parent does not have access to a computer or smartphone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mehealth portal with integrated behavioral tools
Patients in this arm will continue to use the mehealth for ADHD web-based software for ADHD care but will also have access to a module that allows parents and teachers to develop and implement behavioral interventions such as daily report cards online.
|
Integrated functionality within the mehealth for ADHD software allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules.
Baseline data is gathered online and algorithms derive a set of behavioral goals for the child.
Thereafter, parents or teachers record the child's performance directly into the software.
Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child.
Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly.
The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician "report card"; and 7) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems.
|
|
Other: mehealth portal with no integrated behavioral tools
Patients in this arm will continue to use the mehealth for ADHD web-based software for ADHD care but will wait one year before getting access to the behavioral intervention features.
|
The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician "report card"; and 7) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rates of Behavioral Treatment
Time Frame: 12 months after randomization
|
Parent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview
|
12 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Rating of School Performance on Impairment Rating Scale
Time Frame: 6 months after randomization
|
Parent rating of child's impairment on School Performance on the Impairment Rating Scale.
Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
|
6 months after randomization
|
|
Teacher Rating of Academic Performance on Impairment Rating Scale
Time Frame: 6 months after randomization
|
Teacher rating of child's impairment on Academic Performance on the Impairment Rating Scale.
Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
|
6 months after randomization
|
|
Teacher Rating of Classroom Performance on Impairment Rating Scale
Time Frame: 6 months after randomization
|
Teacher rating of child's impairment on Classroom Performance on the Impairment Rating Scale.
Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
|
6 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2018
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
August 31, 2020
Study Registration Dates
First Submitted
August 10, 2018
First Submitted That Met QC Criteria
August 10, 2018
First Posted (Actual)
August 14, 2018
Study Record Updates
Last Update Posted (Actual)
February 25, 2022
Last Update Submitted That Met QC Criteria
December 8, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R18HS024690 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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