Preschool ADHD On-line Behavioral Treatment

NCT ID: NCT04402528

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-27
• Study Completion Date: 2021-05-30

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.

Detailed Description

Although behavioral interventions are the recommended first-line treatment for preschool children with Attention Deficit Hyperactivity Disorder (ADHD), the majority of preschool children receiving treatment for ADHD are treated with medication only. Barriers to preschool children receiving behavioral treatments include financial limitations, family logistical challenges, and the paucity of trained providers. Web-based approaches may be one innovative way to address these obstacles. Thus, the goal of the proposed study is to pilot-test an on-line behavioral intervention that has been integrated into the evidence-based mehealth for ADHD software (mehealth.com) to determine feasibility, acceptability, and preliminary efficacy. The investigators will enroll a community-based sample of caregivers and teachers/childcare providers of 20 preschool children with ADHD recruited from two DBPNet sites (Cincinnati and Boston) who will utilize the on-line behavioral tools to create and implement child behavior plans. The investigators will track system usage over a 9-month period to determine feasibility for mehealth's integrated behavioral tools intervention. Standardized measures and open-ended questions will be used to determine the intervention's acceptability to parents and teachers/childcare providers. In addition, parent and teacher/childcare providers ratings of child ADHD symptoms and impairment collected at baseline and at the 3-month, 6-month, and 9-month time points will be examined to provide preliminary estimates of efficacy. Ultimately, development of the mehealth for ADHD.com integrated behavioral tools may provide a cost-effective and convenient means of implementing behavioral plans for young children, thereby increasing access to behavioral treatments for preschoolers with ADHD. This scalable and disseminatable approach has great potential for use not only in clinical settings, but also in national Developmental-Behavioral Pediatrics Research Network multi-site research studies which require standardized behavioral intervention packages for preschool ADHD.

Conditions

ADHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mehealth portal with integrated behavioral tools

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.

Group Type: EXPERIMENTAL

Behavioral tools integrated within mehealth for ADHD software

Intervention Type: 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.

Interventions

Behavioral tools integrated within mehealth for ADHD software

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

mehealth for ADHD

Eligibility Criteria

Inclusion Criteria

• 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.

• Children will be given a research diagnosis of ADHD if the following criteria are met: 1) parents endorse that children have 6 or more symptoms in either the inattentive or hyperactive-impulsive domains present "often" or "very often" on the ADHD Rating Scale IV-Preschool Version (ADHD-RS-IV-P) or Vanderbilt ADHD Rating Scale; or have inattentive symptom scores and/or hyperactive symptom scores >93th percentile for sex on the ADHD-RS-IV-P AND 2) child is experiencing ADHD-related impairment as shown by the parent or a teacher/childcare provider/additional adult scoring one or more items on the Impairment Rating Scale as a 3 or higher. Note: child behavior ratings from a teacher/childcare provider/additional adult on the ADHD-RS-IV-P and Impairment Rating Scale will not be required for study inclusion and children will not be excluded from the study on the basis of these ratings. Parents of children with a research diagnosis of ADHD will be eligible for study participation.

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Developmental Behavioral Pediatrics Research Network

UNKNOWN

Sponsor Role: collaborator

HRSA/Maternal and Child Health Bureau

FED

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Tanya Froehlich, MD

Professor of Pediatrics and Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tanya Froehlich, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2019-1274

Identifier Type: -

Identifier Source: org_study_id