ADHDNCT03628781
Improving ADHD Behavioral Care
A study testing Behavioral tools integrated within mehealth for ADHD software and mehealth for ADHD in people with ADHD, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Behavioral tools integrated within mehealth for ADHD software and mehealth for ADHD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- parent does not have access to a computer or smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3026
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- Behavioral tools integrated within mehealth for ADHD software, mehealth for ADHD
- Keywords
- Behavioral intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral tools integrated within mehealth for ADHD softwareOther
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.
mehealth for ADHDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| mehealth portal with integrated behavioral tools | Experimental | 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. Receives: Other: Behavioral tools integrated within mehealth for ADHD software; Other: mehealth for ADHD |
| mehealth portal with no integrated behavioral tools | Other | 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. Receives: Other: mehealth for ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Behavioral Treatment
Parent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview
Measured: 12 months after randomization
Secondary outcomes (3)
Parent Rating of School Performance on Impairment Rating Scale
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).
Measured: 6 months after randomization
Teacher Rating of Academic Performance on Impairment Rating Scale
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).
Measured: 6 months after randomization
Teacher Rating of Classroom Performance on Impairment Rating Scale
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).
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start17 Sep 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Jeff Epstein, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628781
- Sponsor's protocol ID
- R18HS024690
- Status last verified
- Dec 2021
- First submitted
- 10 Aug 2018
- Last updated
- 25 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving ADHD Behavioral Care Quality in Community-Based Pediatric Settings
- ClinicalTrials.gov ID
- NCT03628781
- Acronym / sponsor ID
- R18HS024690
- Conditions
- ADHD
- Keywords
- Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 25 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mehealth portal with integrated behavioral tools | Experimental | Other: Behavioral tools integrated within mehealth for ADHD software, Other: mehealth for ADHDPatients 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. |
| mehealth portal with no integrated behavioral tools | Other | Other: mehealth for ADHDPatients 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- parent does not have access to a computer or smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral tools integrated within mehealth for ADHD softwareIntegrated 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. | Other | mehealth portal with integrated behavioral tools |
| mehealth for ADHDThe 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 integrated behavioral tools, mehealth portal with no integrated behavioral tools |
Primary outcome
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
3 secondary outcomes
Parent Rating of School Performance on Impairment Rating Scale
Time frame: 6 months after randomization
Teacher Rating of Academic Performance on Impairment Rating Scale
Time frame: 6 months after randomization
Teacher Rating of Classroom Performance on Impairment Rating Scale
Time frame: 6 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral tools integrated within mehealth for ADHD software and mehealth for ADHD in people with ADHD, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Behavioral Treatment (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.