Benefits of ADHD Treatment in Detained People (BATIR)

Stéphanie Baggio

Status and phase: Enrolling; Phase 3

Conditions: ADHD

Treatments: Drug: Concerta; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05842330

32003B_212581

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Pharmaceutical intervention (OROS-MPH)

Experimental group

Description:

Participants will receive OROS-MPH (Concerta® available in Switzerland as first-line treatment for ADHD). Dosages will be defined according to the Swiss Compendium. The psychiatrist (blinded during detention) will start with the smallest dosage (18 mg, Concerta®). The treatment will be monitored weekly the first month, and then monthly. The pharmacy of the Geneva University Hospitals will be in charge of over-encapsulating medications.

Treatment:

Drug: Concerta

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo