Preschool ADHD On-line Behavioral Treatment

NCT04402528 | Completed

• 1 other identifier: 2019-1274
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the proposed project is to test the feasibility of parent and teacher/childcare providers use of the ADHD web portal-integrated behavioral treatment modules with preschool children with ADHD in order to improve the access to and the integrity of evidence-based behavioral treatment strategies for young children with ADHD.

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• % of days using mehealth behavior tracking system

  Feasibility will be assessed by tracking system usage, including % of days when parents/teachers/childcare providers entered behavioral tracking data (to determine if data was entered for \>85% of days) and % of days when earned rewards were administered (to determine if administration occurred for \>85% of days).

  9 months

• Acceptability with on-line behavioral treatment assessed by the System Usability Scale

  System Usability Scale contains ten items rated on a Likert scale. \- SUS contains ten items rated on a Likert scale. Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire (IAQ). \- The IAQ contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program.

  9 months

• Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire

  The Intervention Acceptability Questionnaire contains 3 open-ended questions regarding satisfaction with the on-line behavioral treatment program

  9 months

Secondary Outcomes (2)

• ADHD Rating Scale-IV-Preschool Version

  9 months

• Impairment Rating Scale

  9 months

Study Arms (1)

mehealth portal with integrated behavioral tools

EXPERIMENTAL

Patients in this arm will use the mehealth for ADHD web-based software and have access to a module that allows parents and teachers/childcare providers to develop and implement behavioral interventions such as daily report cards online.

Behavioral: Behavioral tools integrated within mehealth for ADHD software

Interventions

Behavioral tools integrated within mehealth for ADHD software BEHAVIORAL

Integrated functionality within the mehealth for ADHD software allows parents and teachers/childcare providers 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.

Also known as: mehealth for ADHD

mehealth portal with integrated behavioral tools

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child has been diagnosed with ADHD, or shows significant signs and symptoms of ADHD.
• If child is being prescribed ADHD medication, child must currently be on a stable dosage of medication for 1 month.
• Child meets criteria for a research diagnosis of ADHD\* based on the ADHD Rating Scale IV Preschool-Version and Impairment Rating Scale assessments that the parent completes.

You may not qualify if:

• Parent does not have access to a computer or smartphone.
• Child has global developmental delay.
• Child has been diagnosed with autism spectrum disorder.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Developmental Behavioral Pediatrics Research Network: collaborator
• HRSA/Maternal and Child Health Bureau: collaborator
• Boston Children's Hospital: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Tanya Froehlich, MD, MS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Director of Research

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 27, 2020
• Study Start: March 27, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)