Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305078
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-02-13
Brief Title:
Personalized Attention-DeficitHyperactivity Disorder ADHD Medication Experiment Study
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Open-Label Trial of Personalized Medication Experiments to Inform Decisions About Future Attention-DeficitHyperactivity Disorder ADHD Medication Use
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 project is to test personalized medication experiments to inform decisions about future medication use Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use The investigators view this open label trial as a pilot study to test the feasibility acceptability and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial
Detailed Description:
The investigators will conduct a pilot single-arm open-label trial of the medication experiment intervention among 30 adolescents and parents experiencing uncertainty about continued medicine use Because the medication experiment intervention is not clinically relevant for adolescents taking a non-stimulant ADHD medication they will be excluded At the time of enrollment families will complete baseline measures electronically and schedule an in-person visit The investigators will verify the medication prescribed and the number of days covered with medicine in the past year using dispensing data During the visit parents and adolescents will choose one of five medication experiments to complete together and track the effects for the desired amount of time
1 Make no changes Track current state continue to take medication as it is currently prescribed
2 Take medication on non-school days Track effects If not currently taking medication on non-school days start taking medication on those days and track the effects
3 Stop taking medication on non-school days Track effects If currently taking medication on non-school days stop taking medication on those days and track the effects
4 Do a formal trial off of medication Take current medication as currently prescribed for 2 weeks while tracking then stop taking medication for 2-4 weeks while continuing to track
5 Change dose or change medication Consider a different medication or different dose of current medication in consultation with study doctor Track the effects
Once dyads have completed the medication experiment they will complete a follow-up study visit to review the results from the experiment discuss feasibility of the software and complete end of study measures
1 Make no changes Track current state continue to take medication as it is currently prescribed
2 Take medication on non-school days Track effects If not currently taking medication on non-school days start taking medication on those days and track the effects
3 Stop taking medication on non-school days Track effects If currently taking medication on non-school days stop taking medication on those days and track the effects
4 Do a formal trial off of medication Take current medication as currently prescribed for 2 weeks while tracking then stop taking medication for 2-4 weeks while continuing to track
5 Change dose or change medication Consider a different medication or different dose of current medication in consultation with study doctor Track the effects
Once dyads have completed the medication experiment they will complete a follow-up study visit to review the results from the experiment discuss feasibility of the software and complete end of study measures
Study Oversight
Has Oversight DMC:
None
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?:
None