Improving ADHD Behavioral Care

NCT03628781 | Completed Results

• 1 other identifier: R18HS024690
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Rates of Behavioral Treatment

  Parent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview

  12 months after randomization

Secondary Outcomes (3)

• Parent Rating of School Performance on Impairment Rating Scale

  6 months after randomization

• Teacher Rating of Academic Performance on Impairment Rating Scale

  6 months after randomization

• Teacher Rating of Classroom Performance on Impairment Rating Scale

  6 months after randomization

Study Arms (2)

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.

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.

Other: mehealth for ADHD

Interventions

Behavioral tools integrated within mehealth for ADHD software OTHER

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 portal with integrated behavioral tools

mehealth for ADHD OTHER

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.

mehealth portal with integrated behavioral tools; mehealth portal with no integrated behavioral tools

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• parent does not have access to a computer or smartphone

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3026, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jeff Epstein
• Organization: Cincinnati Children's Hospital Medical Center

jeff.epstein@cchmc.org

15136368296

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 14, 2018
• Study Start: September 17, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 25, 2022
• Results First Posted: February 25, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)