Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429221
Status:
WITHDRAWN
Last Update Posted:
2013-04-23
First Post:
2007-01-30
Brief Title:
Parent-Provider Intervention for Improving Medication Adherence in Children With Attention Deficit Hyperactivity Disorder
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
ADHD Medication Adherence A Parent-Provider Intervention Modeled From HIV
Status:
WITHDRAWN
Status Verified Date:
2013-04
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:
This three-phase study will develop and test a provider-administered intervention to improve medication adherence and promote sustained medication use among children with ADHD and their caregivers
Detailed Description:
Attention deficit hyperactivity disorder ADHD is a common childhood behavior disorder that causes impaired functioning in multiple settings including home school and in relationships with peers Symptoms of ADHD include impulsiveness hyperactivity and inattention Both medications and behavior therapies have been shown to be effective in treating ADHD It is essential however that children take their medication regularly for it to be effective This three-phase study will develop and test a provider-administered intervention to improve medication adherence and persistence among children with ADHD and their caregivers
The first phase of this study will gather information about perspectives on ADHD and its treatment by using focus groups and interviews with participating children and their parents Phase two of the study will gather information on medication adherence and persistence as well as demographic information Phase three of the study will involve developing and testing a three part intervention consisting of an ADHD education component a short survey to help parents identify non-adherence warning signs and tailored medication messages for parents After conducting a pilot with five parent-child pairs to assess feasibility and accessibility all interested doctors at the study site will receive a lecture on evidence-based treatments for ADHD and a supply of parent ADHD education toolkits Half of the doctors will be randomly assigned to receive additional training on the experimental procedures and to administer the intervention as part of the study Parent and child participants will be randomly assigned to receive either treatment with a doctor who has been trained on the experimental intervention or treatment as usual Assessments will take place at the beginning of treatment and 1 3 and 6 months after the start of treatment During each assessment a saliva sample will be collected from the child and parents will complete several checklists and questionnaires about ADHD treatment and medication adherence
The first phase of this study will gather information about perspectives on ADHD and its treatment by using focus groups and interviews with participating children and their parents Phase two of the study will gather information on medication adherence and persistence as well as demographic information Phase three of the study will involve developing and testing a three part intervention consisting of an ADHD education component a short survey to help parents identify non-adherence warning signs and tailored medication messages for parents After conducting a pilot with five parent-child pairs to assess feasibility and accessibility all interested doctors at the study site will receive a lecture on evidence-based treatments for ADHD and a supply of parent ADHD education toolkits Half of the doctors will be randomly assigned to receive additional training on the experimental procedures and to administer the intervention as part of the study Parent and child participants will be randomly assigned to receive either treatment with a doctor who has been trained on the experimental intervention or treatment as usual Assessments will take place at the beginning of treatment and 1 3 and 6 months after the start of treatment During each assessment a saliva sample will be collected from the child and parents will complete several checklists and questionnaires about ADHD treatment and medication adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR 96-BHA | US NIH GrantContract | None | httpsreporternihgovquickSearchR34MH078700 |
| R34MH078700 | NIH | None | None |