Clinical trial NCT05842330: Benefits of ADHD Treatment in Detained People
Official title: Benefits of In-prison OROS-methylphenidate Vs. Placebo Treatment in Detained People with Attention-deficit/hyperactivity Disorder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: ADHD
Keywords: Prison
Health care
Adherence to treatment
Recidivism
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Lausanne
name: University of Geneva, Switzerland
name: Netherlands Institute for the Study of Crime
name: School of Health Sciences Fribourg
First posted: 2023-05-06
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase 3 parallel randomized controlled trial (1:1 ratio) of OROS-MPH vs. a placebo on a clinical outcome.

Participants will undertake three months (12 weeks) of treatment while they are incarcerated. After three months, all participants will be offered treatment in outpatient care, either in prison or in the community. They will have daily monitoring of medical adherence in prison or in electronic monitors after release (without being unblinded on the treatment they received during detention). They will be followed-up for twelve months as outpatient care (total study duration: 15 months).
Primary purpose: TREATMENT

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 (e.g., 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 (1:1 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.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 65
* good command of French
* stay in prison approx. 4 months at eligibility visit
* endorsing clinical diagnostic criteria for DSM-5 ADHD
* providing written informed consent

Exclusion Criteria:

* presence of an acute uncontrolled comorbid psychiatric disorder
* medical contraindication to stimulant prescription
* potential adverse interaction with another medication
* already receive ADHD treatment

Primary outcomes:
measure: Severity of ADHD core symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Number of acute events
timeFrame: 3 months
measure: Score of risk of recidivism
timeFrame: 3 months
measure: Percentage of adherence to medication
timeFrame: 3 months and 12 months in outpatient care
measure: Percentage of retention to study
timeFrame: 12 months in outpatient care
measure: Costs
timeFrame: 3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related costs)
measure: Number of rule-breaking events
timeFrame: 12 months in outpatient care
Other outcomes:
measure: Number of side effects
timeFrame: 3 months
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References: