Benefits of ADHD Treatment in Detained People (BATIR)

Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Drug: Concerta; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1211
      • Recruiting
      • Geneva University Hospitals
      • Contact: Patrick Heller, MD; Phone Number: +41223055218; Email: patrick.heller@hug.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; The placebo will be strictly identical (same packaging, size no. 2 and color according to dosage, with no label). Procedure for adjustment of dosage will be the same as in the Concerta arm.
Experimental: Pharmaceutical intervention (OROS-MPH); 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.	Drug: Concerta; Dosages of Concerta® will be defined according to the Swiss Compendium (from 18 to 72 mg/d). The psychiatrist will start with the smallest dosage (18 mg) and will adapt it on a weekly basis or on need, depending on tolerance (side effects measured at each visit), clinical response (subjective improvement felt by the patient in terms of attention, impulsivity, and hyperactivity), and according to the observations made by the professionals or patient's entourage in term of attention, impulsivity, hyperactivity, and for this project, behavioral problems. In general, the dose can be increased in 18 mg at weekly intervals. The treatment will be monitored weekly the first month, and then monthly, except for side effects which will be monitored daily in prison and every two weeks after release.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of ADHD core symptoms	Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of acute events	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	3 months
Score of risk of recidivism	Dynamic risk assessment tool will be used to evaluate the risk of recidivism, score 0-30, higher score indicates better outcome	3 months
Percentage of adherence to medication	Binary variable (yes=adherence to medication, no=absence of adherence to medication)	3 months and 12 months in outpatient care
Percentage of retention to study	Binary variable (yes=remain in the study, no=dropout from the study)	12 months in outpatient care
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.	3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related costs)
Number of rule-breaking events	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)	12 months in outpatient care

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of side effects	Side effects according to the Swiss compendium (number of side effects)	3 months

Collaborators and Investigators

• Sponsor: Stéphanie Baggio
• Collaborators: University of Lausanne; University of Geneva, Switzerland; Netherlands Institute for the Study of Crime; School of Health Sciences Fribourg

Publications and helpful links

General Publications

• Baggio S, Billieux J, Dirkzwager A, Iglesias K, Moschetti K, Perroud N, Schneider M, Vernaz N, Wolff H, Heller P. Protocol of a monocentric, double-blind, randomized, superiority, controlled trial evaluating the effect of in-prison OROS-methylphenidate vs. placebo treatment in detained people with attention-deficit hyperactivity disorder (BATIR). Trials. 2024 Jan 4;25(1):23. doi: 10.1186/s13063-023-07827-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 22, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Prison; Health care; Adherence to treatment; Recidivism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Behavior; Health Behavior; Criminal Behavior; Attention Deficit Disorder with Hyperactivity; Treatment Adherence and Compliance; Recidivism; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carboxylic Acids; Piperidines; Acids, Carbocyclic; Phenylacetates; Methylphenidate
• Other Study ID Numbers: 32003B_212581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No