Benefits of ADHD Treatment in Detained People
- Registration Number
- NCT05842330
- Lead Sponsor
- Stéphanie Baggio
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 150
- 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
- presence of an acute uncontrolled comorbid psychiatric disorder
- medical contraindication to stimulant prescription
- potential adverse interaction with another medication
- already receive ADHD treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Pharmaceutical intervention (OROS-MPH) Concerta 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.
- Primary Outcome Measures
Name Time Method Severity of ADHD core symptoms 3 months Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome
- Secondary Outcome Measures
Name Time Method Number of acute events 3 months Refusal to see doctors, nurses or lawyers, hunger strikes, self-harm events requiring a visit to the medical unit, fights requiring a visit to the medical unit, and disciplinary sanctions
Score of risk of recidivism 3 months Dynamic risk assessment tool will be used to evaluate the risk of recidivism, score 0-30, higher score indicates better outcome
Percentage of adherence to medication 3 months and 12 months in outpatient care Binary variable (yes=adherence to medication, no=absence of adherence to medication)
Percentage of retention to study 12 months in outpatient care Binary variable (yes=remain in the study, no=dropout from the study)
Costs 3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related costs) Medical costs (costs of medical services used by patients (outpatient, emergency, and inpatient resources) and prison-related costs (disciplinary sanctions, use of resources in the prison and in prison staff and recidivism-related costs, average cost for one day in prison), two quantitative variables in Swiss francs.
Number of rule-breaking events 12 months in outpatient care Composite outcome with sanctions recorded in prison and recidivism from the official Swiss criminal records (Federal Office of Statistics, Criminal Conviction Statistics) after release, binary variable (yes=rule-breaking behaviour, no=no rule-breaking behaviour)
Trial Locations
- Locations (1)
Geneva University Hospitals
🇨🇭Geneva, Switzerland