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NCT03628781

Improving ADHD Behavioral Care

Completed NA Results posted Last updated 25 February 2022
What this trial tests

NA trial testing Behavioral tools integrated within mehealth for ADHD software in ADHD in 169 participants. Completed in 31 August 2020.

Timeline
17 September 2018
Primary endpoint
31 August 2020
31 August 2020

Quick facts

Lead sponsorChildren's Hospital Medical Center, Cincinnati
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment169
Start date17 September 2018
Primary completion31 August 2020
Estimated completion31 August 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 5 to 12, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rates of Behavioral Treatment Primary · 12 months after randomization

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

GroupValue95% CI
Mehealth Portal With Integrated Behavioral Tools44
Mehealth Portal With no Integrated Behavioral Tools64
Parent Rating of School Performance on Impairment Rating Scale Secondary · 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).

GroupValue95% CI
Mehealth Portal With Integrated Behavioral Tools3.14± 1.65
Mehealth Portal With no Integrated Behavioral Tools3.50± 1.48
Teacher Rating of Academic Performance on Impairment Rating Scale Secondary · 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).

GroupValue95% CI
Mehealth Portal With Integrated Behavioral Tools2.87± 1.95
Mehealth Portal With no Integrated Behavioral Tools3.38± 1.69
Teacher Rating of Classroom Performance on Impairment Rating Scale Secondary · 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).

GroupValue95% CI
Mehealth Portal With Integrated Behavioral Tools2.27± 1.82
Mehealth Portal With no Integrated Behavioral Tools2.21± 1.78

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Treatment of ADHD: Drugs, psychological therapies, devices, complementary and alternative methods as well as the trends in clinical trials.
    Nazarova VA, Sokolov AV, Chubarev VN, Tarasov VV, et al · · 2022 · cited 44× · PMID 36467081 · DOI 10.3389/fphar.2022.1066988

Verify or expand the search:

Other trials of Behavioral tools integrated within mehealth for ADHD software

Trials testing the same drug.

Other recruiting trials for ADHD

Currently open trials in the same condition.

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03628781.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing