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Clinical Trials/NCT03628781
NCT03628781CompletedNot Applicable

Improving ADHD Behavioral Care Quality in Community-Based Pediatric Settings

Children's Hospital Medical Center, Cincinnati1 site in 1 country169 target enrollmentStarted: September 17, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
169
Locations
1
Primary Endpoint
Rates of Behavioral Treatment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
5 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Behavioral tools integrated within mehealth for ADHD software (Other)

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.

Intervention: mehealth for ADHD (Other)

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.

Intervention: mehealth for ADHD (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Teacher Rating of Classroom Performance on Impairment Rating Scale(6 months after randomization)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeff Epstein

Professor

Children's Hospital Medical Center, Cincinnati

Study Sites (1)

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