Clinical trial NCT04402528: Preschool ADHD On-line Behavioral Treatment
Official title: Improving Rates of Behavioral Treatment in Preschoolers Through Mehealth for ADHD Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Developmental Behavioral Pediatrics Research Network
name: HRSA/Maternal and Child Health Bureau
name: Boston Children's Hospital
First posted: 2020-05-27
Enrollment: 31
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: % of days using mehealth behavior tracking system
timeFrame: 9 months
measure: Acceptability with on-line behavioral treatment assessed by the System Usability Scale
timeFrame: 9 months
measure: Acceptability with on-line behavioral treatment assessed by the Intervention Acceptability Questionnaire
timeFrame: 9 months
Secondary outcomes:
measure: ADHD Rating Scale-IV-Preschool Version
timeFrame: 9 months
measure: Impairment Rating Scale
timeFrame: 9 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Tanya Froehlich, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: