Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT04402528
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2020-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preschool ADHD On-line Behavioral Treatment
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
Improving Rates of Behavioral Treatment in Preschoolers Through Mehealth for ADHD Software
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: