Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842330
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-04-05
Brief Title:
Benefits of ADHD Treatment in Detained People
Sponsor:
Stéphanie Baggio
Organization:
University Hospital Geneva
Study Overview
Official Title:
Benefits of In-prison OROS-methylphenidate Vs Placebo Treatment in Detained People with Attention-deficithyperactivity Disorder a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Attention deficit hyperactivity disorder ADHD is characterized by difficulties paying attention poor impulse control and hyperactive behaviors It is associated with several health and social detrimental outcomes and leads to increased risks of criminality and recidivism However to date ADHD treatment has been neglected in prison This project will test the efficacy of ADHD treatment using a randomized controlled trial
Detailed Description:
This project aims to compare the efficacy of a three-month in-prison OROS-methylphenidate vs placebo treatment on the severity of ADHD core symptoms Secondary outcomes address additional important in-prison and outpatient in-prison or post-prison aspects 1 reduction in acute events in prison eg disciplinary sanctions violence misuse of ADHD treatment 2 evaluation of the risk of recidivism upon release 3 three-month side effects of treatment 4 in- and post-prison adherence to medication 5 in- and post-prison study retention 6 in- and post-prison costs-benefits of treatment and 8 one-year rule-breaking behaviour The outpatient part of the project will highlight long-lasting benefits of a treatment provided during three months while people are detained
These research questions will be answered using a randomized controlled trial After randomization the participants will undertake three months of treatment with OROS-MPH or placebo 11 ratio while they are incarcerated After three months all participants will be offered the possibility to have the treatment but they will remain blinded regarding their initial study group All of them will benefit of a cognitive-behavioral psycho-education program during detention and a cognitive-behavioral therapy after release
The RCT will provide empirical-based evidence of the benefits of in-prison ADHD treatment using different perspectives Clinical behavioral rule-breaking-related and economical The investigators expect that early detection and treatment of ADHD in prison will be an important public health opportunity and a cost-effective approach likely to decrease the vulnerability of people living in detention and to promote pathways out criminal involvement
These research questions will be answered using a randomized controlled trial After randomization the participants will undertake three months of treatment with OROS-MPH or placebo 11 ratio while they are incarcerated After three months all participants will be offered the possibility to have the treatment but they will remain blinded regarding their initial study group All of them will benefit of a cognitive-behavioral psycho-education program during detention and a cognitive-behavioral therapy after release
The RCT will provide empirical-based evidence of the benefits of in-prison ADHD treatment using different perspectives Clinical behavioral rule-breaking-related and economical The investigators expect that early detection and treatment of ADHD in prison will be an important public health opportunity and a cost-effective approach likely to decrease the vulnerability of people living in detention and to promote pathways out criminal involvement
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