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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Study protocol

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)

Authors: Stéphanie Baggio, Joël Billieux, Anja Dirkzwager, Katia Iglesias, Karine Moschetti, Nader Perroud, Marie Schneider, Nathalie Vernaz, Hans Wolff, Patrick Heller

Published in: Trials | Issue 1/2024

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Abstract

Background

Attention-deficit hyperactivity disorder (ADHD) is characterized by difficulty paying attention, poor impulse control, and hyperactive behavior. It is associated with several adverse health and social outcomes and leads to an increased risk of criminality and recidivism. Worldwide, ADHD is thus highly prevalent in prisons. However, ADHD treatment has been neglected in such environments. Stimulant medications such as osmotic-release oral system methylphenidate (OROS-MPH) are first-line treatments in the general population, but they are under-prescribed in prisons due to concerns about abuse, even though such claims are not empirically supported. This project aims to compare the efficacy of a 3-month in-prison OROS-MPH vs. placebo treatment on the severity of core ADHD symptoms and relevant in- and post-prison outcomes.

Methods

This study is a phase III, double-blinded, randomized, superiority, controlled trial of OROS-MPH vs. placebo. After randomization, the participants will receive 3 months of treatment with OROS-MPH or placebo (1:1 ratio) while incarcerated. Upon release, all participants will be offered the treatment (OROS-MPH) for 1 year but will remain blinded to their initial study group. The study will be conducted at the Division of Prison Health, Geneva, Switzerland, among incarcerated men (n = 150). Measures will include (1) investigator-rated ADHD symptoms, (2) acute events collected by the medical and prison teams, (3) assessment of the risk of recidivism, (4) medication side effects, (5) medication adherence, (6) study retention, (7) health care/prison costs, and (8) 1-year recidivism. Analyses will include bivariable and multivariable modeling (e.g., regression models, mixed-effects models, survival analyses) and an economic evaluation (cost-benefit analysis).

Discussion

We expect that early identification and treatment of ADHD in prison will be an important public health opportunity and a cost-effective approach that is likely to reduce the vulnerability of incarcerated individuals and promote pathways out of criminal involvement. The study will also promote standards of care for people with ADHD in prison and provide recommendations for continuity of care after release.

Trial registration

ClinicalTrials.​govNCT05842330. Registered on June 5, 2023.
Kofam.ch SNCTP000005388. Registered on July 17, 2023.
Appendix
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Literature
1.
APA. Diagnostic and Statistical Manual of Mental Disorders, fifth ed. (DSM-5). Arlington, VA: American Psychiatric Publishing; 2013.
2.
Ramos-Quiroga JA, Montoya A, Kutzelnigg A, Deberdt W, Sobanski E. Attention deficit hyperactivity disorder in the European adult population: prevalence, disease awareness, and treatment guidelines. Curr Med Res Opin. 2013;29(9):1093–104.PubMedCrossRef
3.
Asherson P, Buitelaar J, Faraone SV, Rohde LA. Adult attention-deficit hyperactivity disorder: key conceptual issues. Lancet Psychiatry. 2016;3(6):568–78.PubMedCrossRef
4.
Shaw M, Hodgkins P, Caci H, Young S, Kahle J, Woods AG, et al. A systematic review and analysis of long-term outcomes in attention deficit hyperactivity disorder: effects of treatment and non-treatment. BMC Med. 2012;10:99.PubMedPubMedCentralCrossRef
5.
Ginsberg Y, Quintero J, Anand E, Casillas M, Upadhyaya HP. Underdiagnosis of attention-deficit/hyperactivity disorder in adult patients: a review of the literature. Prim Care Companion CNS Disord. 2014;16(3)
6.
Lange H, Buse J, Bender S, Siegert J, Knopf H, Roessner V. Accident proneness in children and adolescents affected by ADHD and the impact of medication. J Atten Disord. 2016;20(6):501–9.PubMedCrossRef
7.
Sabuncuoglu O, Irmak MY. The attention-deficit/hyperactivity disorder model for traumatic dental injuries: a critical review and update of the last 10 years. Dent Traumatol. 2017;33(2):71–6.PubMedCrossRef
8.
Mohr-Jensen C, Steinhausen H-C. A meta-analysis and systematic review of the risks associated with childhood attention-deficit hyperactivity disorder on long-term outcome of arrests, convictions, and incarcerations. Clin Psychol Rev. 2016;48(Supplement C):32–42.PubMedCrossRef
9.
Young S, Moss D, Sedgwick O, Fridman M, Hodgkins P. A meta-analysis of the prevalence of attention deficit hyperactivity disorder in incarcerated populations. Psychol Med. 2015;45(2):247–58.PubMedCrossRef
10.
Philipp-Wiegmann F, Rösler M, Clasen O, Zinnow T, Retz-Junginger P, Retz W. ADHD modulates the course of delinquency: a 15-year follow-up study of young incarcerated man. Eur Arch Psychiatry Clin Neurosci. 2017;1-9
11.
Baggio S, Fructuoso A, Guimaraes M, Fois E, Golay D, Heller P, et al. Prevalence of attention deficit hyperactivity disorder in detention settings: a systematic review and meta-analysis. Front. Psychiatry. 2018;9
12.
Polanczyk GV, Willcutt EG, Salum GA, Kieling C, Rohde LA. ADHD prevalence estimates across three decades: an updated systematic review and meta-regression analysis. Int J Epidemiol. 2014;43(2):434–42.PubMedPubMedCentralCrossRef
13.
Ramos-Quiroga JA, Nasillo V, Fernández-Aranda F, Fernández-Arana F, Casas M. Addressing the lack of studies in attention-deficit/hyperactivity disorder in adults. Expert Rev Neurother. 2014;14(5):553–67.PubMedCrossRef
14.
Gordon V, Williams DJ, Donnelly PD. Exploring the relationship between ADHD symptoms and prison breaches of discipline amongst youths in four Scottish prisons. Public Health. 2012;126(4):343–8.PubMedCrossRef
15.
Young S, Gudjonsson GH, Wells J, Asherson P, Theobald D, Oliver B, et al. Attention deficit hyperactivity disorder and critical incidents in a Scottish prison population. Personal Individ Differ. 2009;46(3):265–9.CrossRef
16.
Berryessa CM. Attention, reward, and inhibition: symptomatic features of ADHD and issues for offenders in the criminal justice system. Atten Defic Hyperact Disord. 2017;9(1):5–10.PubMedCrossRef
17.
Hall RCW, Myers WC. Challenges and limitations to treating ADHD in incarcerated populations. J Am Acad Psychiatry Law. 2016;44(2):164–70.PubMed
18.
González RA, Gudjonsson GH, Wells J, Young S. The role of emotional distress and ADHD on institutional behavioral disturbance and recidivism among offenders. J Atten Disord. 2016;20(4):368–78.PubMedCrossRef
19.
Philipp-Wiegmann F, Rösler M, Clasen O, Zinnow T, Retz-Junginger P, Retz W. ADHD modulates the course of delinquency: a 15-year follow-up study of young incarcerated man. Eur Arch Psychiatry Clin Neurosci. 2018;268(4):391–9.PubMedCrossRef
20.
Valero S, Bosch R, Corominas M, Barrau V, Ramos-Quiroga JA, Casas M. Remittance or persistence of attention deficit-hyperactivity disorder (ADHD) and its impact on recidivism in risky driving behaviors. Traffic Injury Prevention. 2018;19(7):701–7.PubMedCrossRef
21.
Wojciechowski TW. The role of ADHD in predicting the development of violent behavior among juvenile offenders: Participation versus frequency. J Interpers Violence. 2017;886260517734225
22.
Scott DA, Gignac M, Kronfli RN, Ocana A, Lorberg GW. Expert opinion and recommendations for the management of attention-deficit/hyperactivity disorder in correctional facilities. J Correct Health Care. 2016;22(1):46–61.PubMedCrossRef
23.
Lichtenstein P, Halldner L, Zetterqvist J, Sjölander A, Serlachius E, Fazel S, et al. Medication for attention deficit–hyperactivity disorder and criminality. N Engl J Med. 2012;367(21):2006–14.PubMedPubMedCentralCrossRef
24.
Nice. Diagnosis and management of ADHD in children, young people and adults. 2018 2018.
25.
Cortese S, Adamo N, Del Giovane C, Mohr-Jensen C, Hayes AJ, Carucci S, et al. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2018;5(9):727–38.PubMedPubMedCentralCrossRef
26.
Huss M, Ginsberg Y, Tvedten T, Arngrim T, Philipsen A, Carter K, et al. Methylphenidate hydrochloride modified-release in adults with attention deficit hyperactivity disorder: a randomized double-blind placebo-controlled trial. Adv Ther. 2014;31(1):44–65.PubMedCrossRef
27.
Lam AP, Matthies S, Graf E, Colla M, Jacob C, Sobanski E, et al. Long-term effects of multimodal treatment on adult attention-deficit/hyperactivity disorder symptoms: Follow-up analysis of the COMPAS trial. JAMA Netw Open. 2019;2(5):e194980-e.CrossRef
28.
Arnold LE, Hodgkins P, Caci H, Kahle J, Young S. Effect of treatment modality on long-term outcomes in attention-deficit/hyperactivity disorder: a systematic review. PLoS One. 2015;10(2):e0116407.PubMedPubMedCentralCrossRef
29.
Cherkasova MV, French LR, Syer CA, Cousins L, Galina H, Ahmadi-Kashani Y, et al. Efficacy of cognitive behavioral therapy with and without medication for adults with ADHD: A randomized clinical trial. J Atten Disord. 2016;1087054716671197
30.
López-Pinar C, Martínez-Sanchís S, Carbonell-Vayá E, Fenollar-Cortés J, Sánchez-Meca J. Long-term efficacy of psychosocial treatments for adults with attention-deficit/hyperactivity disorder: A meta-analytic review. Front Psychol. 2018;9:638.PubMedPubMedCentralCrossRef
31.
Young S, Asherson P, Lloyd T, Absoud M, Arif M, Colley WA, et al. Failure of healthcare provision for attention-deficit/hyperactivity disorder in the United Kingdom: A consensus statement. Front. Psychiatry. 2021:12.
32.
French B, Sayal K, Daley D. Barriers and facilitators to understanding of ADHD in primary care: a mixed-method systematic review. Eur Child Adolesc Psychiatry. 2019;28(8):1037–64.PubMedCrossRef
33.
Swift KD, Sayal K, Hollis C. ADHD and transitions to adult mental health services: a scoping review. Child Care Health Dev. 2014;40(6):775–86.PubMedCrossRef
34.
Blozik E, Signorell A, Reich O. How does hospitalization affect continuity of drug therapy: an exploratory study. Ther Clin Risk Manag. 2016;12:1277–83.PubMedPubMedCentralCrossRef
35.
Baggio S, Heller P, Perroud N, Buadze A, Schleifer R, Wolff H, et al. Attention deficit hyperactivity disorder as a neglected psychiatric disease in prison: Call for identification and treatment. Forensic Science International: Mind and Law. 2022;3:100071.
36.
Mattes JA. Treating ADHD in prison: focus on alpha-2 agonists (Clonidine and Guanfacine). J Am Acad Psychiatry Law. 2016;44(2):151–7.PubMed
37.
Autorité de l'Etat et éthique médicale. Conditions cadres pour l’exercice de la médecine carcérale, vol. 2012. Prise de position de la Commission Centrale d’Ethique de l’ASSM; 2012.
38.
Torture TECftPo, Inhumane or Degrading Treatment or Punishment. Standard 2002 (rev. 2011).
39.
Abbott P, Magin P, Lujic S, Hu W. Supporting continuity of care between prison and the community for women in prison: a medical record review. Aust Health Rev. 2017;41(3):268–76.PubMedCrossRef
40.
Jarrett M, Thornicroft G, Forrester A, Harty M, Senior J, King C, et al. Continuity of care for recently released prisoners with mental illness: a pilot randomised controlled trial testing the feasibility of a Critical Time Intervention. Epidemiology and Psychiatric Sciences. 2012;21(2):187–93.PubMedCrossRef
41.
Young JT. Pre-existing mental disorders and health outcomes after release from prison: a case for continuity of care; 2018.
42.
Fuge TG, Tsourtos G, Miller ER. A systematic review and meta-analyses on initiation, adherence and outcomes of antiretroviral therapy in incarcerated people. PLoS One. 2020;15(5):e0233355.PubMedPubMedCentralCrossRef
43.
Hopkin G, Evans-Lacko S, Forrester A, Shaw J, Thornicroft G. Interventions at the transition from prison to the community for prisoners with mental illness: A systematic review. Admin Pol Ment Health. 2018;45(4):623–34.CrossRef
44.
Beaudry G, Yu R, Perry AE, Fazel S. Effectiveness of psychological interventions in prison to reduce recidivism: a systematic review and meta-analysis of randomised controlled trials. Lancet Psychiatry. 2021;8(9):759–73.PubMedPubMedCentralCrossRef
45.
Retz W, Ginsberg Y, Turner D, Barra S, Retz-Junginger P, Larsson H, et al. Attention-Deficit/Hyperactivity Disorder (ADHD), antisociality and delinquent behavior over the lifespan. Neurosci Biobehav Rev. 2021;120:236–48.PubMedCrossRef
46.
Ginsberg Y, Lindefors N. Methylphenidate treatment of adult male prison inmates with attention-deficit hyperactivity disorder: Randomised double-blind placebo-controlled trial with open-label extension. Br J Psychiatry. 2012;200(1):68–73.PubMedCrossRef
47.
Konstenius M, Jayaram-Lindstroem N, Guterstam J, Beck O, Philips B, Franck J. Methylphenidate for attention deficit hyperactivity disorder and drug relapse in criminal offenders with substance dependence: a 24-week randomized placebo-controlled trial. Addiction. 2014;109(3):440–9.PubMedCrossRef
48.
Kouyoumdjian FG, Schuler A, Hwang SW, Matheson FI. Research on the health of people who experience detention or incarceration in Canada: a scoping review. BMC Public Health. 2015;15
49.
Ginsberg Y, Hirvikoski T, Grann M, Lindefors N. Long-term functional outcome in adult prison inmates with ADHD receiving OROS-methylphenidate. Eur Arch Psychiatry Clin Neurosci. 2012;262(8):705–24.PubMedPubMedCentralCrossRef
50.
Asherson P, Johansson L, Holland R, Fahy T, Forester A, Howitt S, et al. Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II). Trials. 2019;20(1):663.PubMedPubMedCentralCrossRef
51.
Asherson PJ, Johansson L, Holland R, Bedding M, Forrester A, Giannulli L, et al. Randomised controlled trial of the short-term effects of osmotic-release oral system methylphenidate on symptoms and behavioural outcomes in young male prisoners with attention deficit hyperactivity disorder: CIAO-II study. Br J Psychiatry. 2022;1-11
52.
Chang Z, Lichtenstein P, Långström N, Larsson H, Fazel S. Association between prescription of major psychotropic medications and violent reoffending After prison release. JAMA. 2016;316(17):1798–807.PubMedPubMedCentralCrossRef
53.
Fazel S, Hayes AJ, Bartellas K, Clerici M, Trestman R. The mental health of prisoners: a review of prevalence, adverse outcomes and interventions. Lancet Psychiatry. 2016;3(9):871–81.PubMedPubMedCentralCrossRef
54.
Le HH, Hodgkins P, Postma MJ, Kahle J, Sikirica V, Setyawan J, et al. Economic impact of childhood/adolescent ADHD in a European setting: the Netherlands as a reference case. Eur Child Adolesc Psychiatry. 2014;23(7):587–98.PubMedCrossRef
55.
Telford C, Green C, Logan S, Langley K, Thapar A, Ford T. Estimating the costs of ongoing care for adolescents with attention-deficit hyperactivity disorder. Soc Psychiatry Psychiatr Epidemiol. 2013;48(2):337–44.PubMedCrossRef
56.
Chhibber A, Watanabe AH, Chaisai C, Veettil SK, Chaiyakunapruk N. Global economic burden of attention-deficit/hyperactivity disorder: A systematic review. PharmacoEconomics. 2021;39(4):399–420.PubMedCrossRef
57.
Young S, González RA, Fridman M, Hodgkins P, Kim K, Gudjonsson GH. The economic consequences of attention-deficit hyperactivity disorder in the Scottish prison system. BMC Psychiatry. 2018;18
58.
Young S, Cocallis KM. Attention Deficit Hyperactivity Disorder (ADHD) in the Prison System. Curr Psychiatry Rep. 2019;21(6):41.PubMedCrossRef
59.
Ahalt C, Sudore R, Bolano M, Metzger L, Darby AM, Williams B. "Teach-to-goal" to better assess informed consent comprehension among incarcerated clinical research participants. AMA J Ethics. 2017;19(9):862–72.PubMedPubMedCentralCrossRef
60.
Cole P, Weibel S, Nicastro R, Hasler R, Dayer A, Aubry J-M, et al. CBT/DBT skills training for adults with attention deficit hyperactivity disorder (ADHD). Psychiatr Danub. 2016;28(Suppl-1):103–7.PubMed
61.
Young S, Bramham J. Cognitive-behavioural therapy for ADHD in adolescents and adults: A psychological guide to practice. 2nd edition ed. Wiley-Blackwell; 2012. p. 2012.CrossRef
62.
Conners CK, Erhardt D, Sparrow E. Conners’ Adult ADHD Rating Scales (CAARS). Technical manual. New York, NY, US: Multi Health Systems Inc; 1999
63.
Macey KD. Review of Conners' Adult ADHD Rating Scales (CAARS). Arch Clin Neuropsychol. 2003;18(4):431–7.CrossRef
64.
Baggio S, Gétaz L, Tran NT, Peigné N, Chacowry Pala K, Golay D, et al. Association of overcrowding and turnover with self-harm in a Swiss pre-trial prison. Int J Environ Res Public Health. 2018;15(4):601.PubMedPubMedCentralCrossRef
65.
66.
Vogel V, Robbé MV, Ruiter C, Bouman YHA. Assessing protective factors in forensic psychiatric practice: Introducing the SAPROF. Int J Forensic Ment Health. 2011;10(3):171–7.CrossRef
67.
Robbé MV, Vogel V, Spa Ed, editors. Protective factors for violence risk in forensic psychiatric patients: A retrospective validation study of the SAPROF. Int J Forensic Ment Health. 2011;10(3):178–86.
68.
Webster CD, Douglas KS, Eaves D, Hart SD. HCR-20 assessing risk for violence manual; Version 2. Haina: MHLPI; 1997.
69.
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22–33. quiz 4-57PubMed
70.
Billieux J, Rochat L, Ceschi G, Carré A, Offerlin-Meyer I, Defeldre A-C, et al. Validation of a short French version of the UPPS-P Impulsive Behavior Scale. Compr Psychiatry. 2012;53(5):609–15.PubMedCrossRef
71.
Dirkzwager AJE, Nieuwbeerta P, Beijersbergen KA, Bosma AQ, de Cuyper R, Doekhie J, et al. Cohort profile: the prison project—a study of criminal behavior and life circumstances before, during, and after imprisonment in the Netherlands. J Dev Life Course Criminology. 2018;4(1):120–35.CrossRef
72.
Yu S, Alper HE, Nguyen A-M, Brackbill RM, Turner L, Walker DJ, et al. The effectiveness of a monetary incentive offer on survey response rates and response completeness in a longitudinal study. BMC Med Res Methodol. 2017;17
73.
Kahan BC, Jairath V, Doré CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014;15(1):139.PubMedPubMedCentralCrossRef
74.
EMA. Guideline on adjustment for baseline covariates in clinical trials. European Medicines Agency. 2015:2015.
75.
Raad H, Cornelius V, Chan S, Williamson E, Cro S. An evaluation of inverse probability weighting using the propensity score for baseline covariate adjustment in smaller population randomised controlled trials with a continuous outcome. BMC Med Res Methodol. 2020;20(1):70.PubMedPubMedCentralCrossRef
76.
Williamson EJ, Forbes A, White IR. Variance reduction in randomised trials by inverse probability weighting using the propensity score. Stat Med. 2014;33(5):721–37.PubMedCrossRef
77.
Ajazi EM. Application of inverse probability weighting to clinical trials of treatment for opiod use disorder. Chapel Hill, USA: University of North Carolina; 2021.
78.
Rabideau DJ, Nierenberg AA, Sylvia LG, Friedman ES, Bowden CL, Thase ME, et al. A novel application of the Intent to Attend assessment to reduce bias due to missing data in a randomized controlled clinical trial. Clin Trials. 2014;11(4):494–502.PubMedPubMedCentralCrossRef
79.
Haavik J, Halmøy A, Lundervold AJ, Fasmer OB. Clinical assessment and diagnosis of adults with attention-deficit/hyperactivity disorder. Expert Rev Neurother. 2010;10(10):1569–80.PubMedCrossRef
80.
Fredriksen M, Halmøy A, Faraone SV, Haavik J. Long-term efficacy and safety of treatment with stimulants and atomoxetine in adult ADHD: a review of controlled and naturalistic studies. Eur Neuropsychopharmacol. 2013;23(6):508–27.PubMedCrossRef
Metadata
Title
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)
Authors
Stéphanie Baggio
Joël Billieux
Anja Dirkzwager
Katia Iglesias
Karine Moschetti
Nader Perroud
Marie Schneider
Nathalie Vernaz
Hans Wolff
Patrick Heller
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07827-7

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