Skip to main content
Top
Published in: Trials 1/2019

Open Access 01-12-2019 | Intellectual Disability | Study protocol

Effectiveness of the serious game ‘You & I’ in changing mentalizing abilities of adults with mild to borderline intellectual disabilities: a parallel superiority randomized controlled trial

Authors: Suzanne Derks, Suze van Wijngaarden, Mirjam Wouda, Carlo Schuengel, Paula S. Sterkenburg

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

Persons with mild to borderline intellectual disabilities generally show dysfunctions in mentalization and stress regulation, resulting in problematic social relationships and personal distress. Intervention programs may improve mentalizing abilities. The aim of this study is to examine the effectiveness of the serious game ‘You & I’ in changing mentalizing abilities and stress regulation in adults with mild to borderline intellectual disabilities.

Methods

A two-arm, parallel, superiority randomized controlled trial will be used with 172 adults with mild to borderline intellectual disabilities. Participants will be randomly assigned to either the experimental group to play the serious game ‘You & I’ or a waitlist control group. Participants will be assessed at baseline, post intervention (5 weeks after baseline), and follow-up (6–8 weeks after post intervention). They also will fill in questionnaires for personal factors, personal development, personal well-being, social validity, autism spectrum quotient (demographic variables), mentalizing abilities (primary outcome measure), and stress regulation (secondary outcome measure).

Discussion

The serious game ‘You & I’ aims to improve mentalizing abilities in adults with mild to borderline intellectual disabilities, which is expected to lead to improved regulation of stress in social relationships. The study’s unique feature is the use of a serious game to improve mentalizing abilities. If the intervention is effective, the serious game can be implemented on a broad scale in Dutch care organizations for people with intellectual disabilities as an effective preventive tool to improve mentalizing abilities.

Trial registration

Netherlands Trial Register, NTR7418. Registered on 2 August 2018.
Appendix
Available only for authorised users
Literature
1.
go back to reference Fonagy P, Bateman AW. Progress in the treatment of borderline personality disorder. Br J Psychiatry. 2006;188:1–3.CrossRef Fonagy P, Bateman AW. Progress in the treatment of borderline personality disorder. Br J Psychiatry. 2006;188:1–3.CrossRef
2.
go back to reference Bateman AW, Fonagy P. Mentalization-based treatment of BPD. J Personal Disord. 2004;18:36–51.CrossRef Bateman AW, Fonagy P. Mentalization-based treatment of BPD. J Personal Disord. 2004;18:36–51.CrossRef
3.
go back to reference Dekker-van der Sande F, Sterkenburg P. Mentalization can be learned. Doorn: Bartiméus; 2016. Dekker-van der Sande F, Sterkenburg P. Mentalization can be learned. Doorn: Bartiméus; 2016.
4.
go back to reference Feenstra D, Bales D. Mentalization-based treatment voor adolescenten. Kinder-Jeugdpsychoterapie. 2015;42:5–20. Feenstra D, Bales D. Mentalization-based treatment voor adolescenten. Kinder-Jeugdpsychoterapie. 2015;42:5–20.
5.
go back to reference Bateman A, Campbell C, Luyten P, Fonagy P. A mentalization-based approach to common factors in the treatment of borderline personality disorder. Curr Opin Psychol. 2018;21:44–9.CrossRef Bateman A, Campbell C, Luyten P, Fonagy P. A mentalization-based approach to common factors in the treatment of borderline personality disorder. Curr Opin Psychol. 2018;21:44–9.CrossRef
6.
go back to reference Baglio G, Blasi V, Intra FS, Castelli I, Massaro D, Baglio F, et al. Social competence in children with borderline intellectual functioning: delayed development of theory of mind across all complexity levels. Front Psychol. 2016;7:1–10. Baglio G, Blasi V, Intra FS, Castelli I, Massaro D, Baglio F, et al. Social competence in children with borderline intellectual functioning: delayed development of theory of mind across all complexity levels. Front Psychol. 2016;7:1–10.
7.
go back to reference Happé FGE. An advanced test of theory of mind: understanding of story characters’ thoughts and feelings by able autistic, mentally handicapped, and normal children and adults. J Autism Dev Disord. 1994;24:129–54.CrossRef Happé FGE. An advanced test of theory of mind: understanding of story characters’ thoughts and feelings by able autistic, mentally handicapped, and normal children and adults. J Autism Dev Disord. 1994;24:129–54.CrossRef
8.
go back to reference Yirmiya N, Erel O, Shaked M, Solomonica-levi D. Meta-analyses comparing theory of mind abilities of individuals with autism, individuals with mental retardation, and normally developing individuals. Psychol Bull. 1998;124:283–307.CrossRef Yirmiya N, Erel O, Shaked M, Solomonica-levi D. Meta-analyses comparing theory of mind abilities of individuals with autism, individuals with mental retardation, and normally developing individuals. Psychol Bull. 1998;124:283–307.CrossRef
9.
go back to reference Bigby C. Known well by no-one: trends in the informal social networks of middle-aged and older people with intellectual disability five years after moving to the community. J Intellect Develop Disabil. 2008;33:148–57.CrossRef Bigby C. Known well by no-one: trends in the informal social networks of middle-aged and older people with intellectual disability five years after moving to the community. J Intellect Develop Disabil. 2008;33:148–57.CrossRef
10.
go back to reference McClure KS, Halpern J, Wolper PA, Donahue JJ. Emotion regulation and intellectual disability. J Dev Disabil. 2014;15:38–44. McClure KS, Halpern J, Wolper PA, Donahue JJ. Emotion regulation and intellectual disability. J Dev Disabil. 2014;15:38–44.
11.
go back to reference Van Nieuwenhuijzen M. Sociale informatieverwerking van kinderen met lichte verstandelijke beperkingen. Kind en Adolesc. 2007;28:97–103.CrossRef Van Nieuwenhuijzen M. Sociale informatieverwerking van kinderen met lichte verstandelijke beperkingen. Kind en Adolesc. 2007;28:97–103.CrossRef
12.
go back to reference Janssen C, Schuengel C. Gehechtheid, stress, gedragsproblemen en psychopathologie bij mensen met een lichte verstandelijke beperking: aanzetten voor interventie. In: Didden R, editor. In perspectief. Gedragsproblemen, psychiatrische stoornissen en lichte verstandelijke beperking. Houten: Bohn Stafleu van Loghum; 2006. p. 67–84. Janssen C, Schuengel C. Gehechtheid, stress, gedragsproblemen en psychopathologie bij mensen met een lichte verstandelijke beperking: aanzetten voor interventie. In: Didden R, editor. In perspectief. Gedragsproblemen, psychiatrische stoornissen en lichte verstandelijke beperking. Houten: Bohn Stafleu van Loghum; 2006. p. 67–84.
13.
go back to reference Choi-Kain LW, Gunderson JG. Mentalization: ontogeny, assessment, and application in the treatment of borderline personality disorder. Am J Psychiatry. 2008;165:1127–35.CrossRef Choi-Kain LW, Gunderson JG. Mentalization: ontogeny, assessment, and application in the treatment of borderline personality disorder. Am J Psychiatry. 2008;165:1127–35.CrossRef
14.
go back to reference Allen JG, Fonagy P, Bateman AW. Mentalizing in clinical practice. Washington, DC: American Psychiatric Association Publishing; 2008. Allen JG, Fonagy P, Bateman AW. Mentalizing in clinical practice. Washington, DC: American Psychiatric Association Publishing; 2008.
17.
go back to reference Bateman AW, Ryle A, Fonagy P, Kerr IB. Psychotherapy for borderline personality disorder: mentalization based therapy and cognitive analytic therapy compared. Int Rev Psychiatry. 2007;19:51–62.CrossRef Bateman AW, Ryle A, Fonagy P, Kerr IB. Psychotherapy for borderline personality disorder: mentalization based therapy and cognitive analytic therapy compared. Int Rev Psychiatry. 2007;19:51–62.CrossRef
18.
go back to reference Fonagy P, Gergely G, Jurist E, Target M. Affect regulation, mentalization, and the development of the self. New York: Other Press; 2002. Fonagy P, Gergely G, Jurist E, Target M. Affect regulation, mentalization, and the development of the self. New York: Other Press; 2002.
19.
go back to reference Verheugt-Pleiter JE, Schmeets MGJ, Zevalkink J. Mentaliseren in de kindertherapie. Koninklijke Van Gorcum: Assen; 2005. Verheugt-Pleiter JE, Schmeets MGJ, Zevalkink J. Mentaliseren in de kindertherapie. Koninklijke Van Gorcum: Assen; 2005.
20.
go back to reference Midgley N, Ensink K, Lindqvist K, Malberg N, Muller N. Mentalization-based treatment for children: a time-limited approach. Washington, DC: American Psychological Association; 2017.CrossRef Midgley N, Ensink K, Lindqvist K, Malberg N, Muller N. Mentalization-based treatment for children: a time-limited approach. Washington, DC: American Psychological Association; 2017.CrossRef
21.
go back to reference Bateman AW, Fonagy P. Handbook of mentalizing in mental health practice. Washington, DC: American Psychiatric Association Publishing; 2012. Bateman AW, Fonagy P. Handbook of mentalizing in mental health practice. Washington, DC: American Psychiatric Association Publishing; 2012.
22.
go back to reference Nolte T, Bolling DZ, Hudac CM, Fonagy P, Mayes L, Pelphrey KA. Brain mechanisms underlying the impact of attachment-related stress on social cognition. Front Hum Neurosci. 2013;7:1–12.CrossRef Nolte T, Bolling DZ, Hudac CM, Fonagy P, Mayes L, Pelphrey KA. Brain mechanisms underlying the impact of attachment-related stress on social cognition. Front Hum Neurosci. 2013;7:1–12.CrossRef
23.
go back to reference Fonagy P, Bateman A. The development of borderline personality disorder—a mentalizing model. J Personal Disord. 2008;22:4–21.CrossRef Fonagy P, Bateman A. The development of borderline personality disorder—a mentalizing model. J Personal Disord. 2008;22:4–21.CrossRef
24.
go back to reference Fonagy P, Luyten P. A developmental, mentalization-based approach to the understanding and treatment of borderline personality disorder. Dev Psychopathol. 2009;21:1355–81.CrossRef Fonagy P, Luyten P. A developmental, mentalization-based approach to the understanding and treatment of borderline personality disorder. Dev Psychopathol. 2009;21:1355–81.CrossRef
25.
go back to reference Blakemore S-J, Frith U. The learning brain: lessons for education. Dev Sci. 2005;6:459–71.CrossRef Blakemore S-J, Frith U. The learning brain: lessons for education. Dev Sci. 2005;6:459–71.CrossRef
26.
go back to reference Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009;166:1355–64.CrossRef Bateman A, Fonagy P. Randomized controlled trial of outpatient mentalization-based treatment versus structured clinical management for borderline personality disorder. Am J Psychiatry. 2009;166:1355–64.CrossRef
27.
go back to reference Jørgensen CR, Freund C, Bøye R, Jordet H, Andersen D, Kjølbye M. Outcome of mentalization-based and supportive psychotherapy in patients with borderline personality disorder: a randomized trial. Acta Psychiatr Scand. 2013;127:305–17.CrossRef Jørgensen CR, Freund C, Bøye R, Jordet H, Andersen D, Kjølbye M. Outcome of mentalization-based and supportive psychotherapy in patients with borderline personality disorder: a randomized trial. Acta Psychiatr Scand. 2013;127:305–17.CrossRef
28.
go back to reference Allen JG, Fonagy P. Handbook of mentalization-based treatment. Chichester: John Wiley & Sons; 2006.CrossRef Allen JG, Fonagy P. Handbook of mentalization-based treatment. Chichester: John Wiley & Sons; 2006.CrossRef
29.
go back to reference Bales D, van Beek N, Smits M, Willemsen S, Busschbach JJV, Verheul R, et al. Treatment outcome of 18-month, day hospital mentalization-based treatment (MBT) in patients with severe borderline personality disorder in the Netherlands. J Personal Disord. 2012;26:568–82.CrossRef Bales D, van Beek N, Smits M, Willemsen S, Busschbach JJV, Verheul R, et al. Treatment outcome of 18-month, day hospital mentalization-based treatment (MBT) in patients with severe borderline personality disorder in the Netherlands. J Personal Disord. 2012;26:568–82.CrossRef
30.
go back to reference Laurenssen EMP, Eeren HV, Kikkert MJ, Peen J, Westra D, Dekker JJM, et al. The burden of disease in patients eligible for mentalization-based treatment (MBT): quality of life and costs. Health Qual Life Outcomes. 2016;14:1–9.CrossRef Laurenssen EMP, Eeren HV, Kikkert MJ, Peen J, Westra D, Dekker JJM, et al. The burden of disease in patients eligible for mentalization-based treatment (MBT): quality of life and costs. Health Qual Life Outcomes. 2016;14:1–9.CrossRef
31.
go back to reference Alvarez J, Damien D. An introduction to serious game: definitions and concepts. In: Proceedings of the Serious Games & Simulation Workshop. Paris; 2011. p. 10–5. Alvarez J, Damien D. An introduction to serious game: definitions and concepts. In: Proceedings of the Serious Games & Simulation Workshop. Paris; 2011. p. 10–5.
32.
go back to reference Connolly TM, Boyle EA, MacArthur E, Hainey T, Boyle JM. A systematic literature review of empirical evidence on computer games and serious games. Comput Educ. 2012;59:661–86.CrossRef Connolly TM, Boyle EA, MacArthur E, Hainey T, Boyle JM. A systematic literature review of empirical evidence on computer games and serious games. Comput Educ. 2012;59:661–86.CrossRef
33.
go back to reference Wouters P, Van der Spek ED, Van Oostendorp H. Current practices in serious game research: a review from a learning outcomes perspective. In: Connolly TM, Stansfield M, Boyle L, editors. Games-based learning advancements for multi-sensory human computer interfaces: techniques and effective practices. Hershey: IGI Global; 2009. p. 232–50.CrossRef Wouters P, Van der Spek ED, Van Oostendorp H. Current practices in serious game research: a review from a learning outcomes perspective. In: Connolly TM, Stansfield M, Boyle L, editors. Games-based learning advancements for multi-sensory human computer interfaces: techniques and effective practices. Hershey: IGI Global; 2009. p. 232–50.CrossRef
34.
go back to reference Den Brok WLJE, Sterkenburg PS. Self-controlled technologies to support skill attainment in persons with an autism spectrum disorder and/or an intellectual disability: a systematic literature review. Disabil Rehabil Assist Technol. 2015;10:1–10.CrossRef Den Brok WLJE, Sterkenburg PS. Self-controlled technologies to support skill attainment in persons with an autism spectrum disorder and/or an intellectual disability: a systematic literature review. Disabil Rehabil Assist Technol. 2015;10:1–10.CrossRef
35.
go back to reference Ypsilanti A, Vivas AB, Räisänen T, Viitala M, Ijäs T, Ropes D. Are serious video games something more than a game? A review on the effectiveness of serious games to facilitate intergenerational learning. Educ Inf Technol. 2014;19:515–29.CrossRef Ypsilanti A, Vivas AB, Räisänen T, Viitala M, Ijäs T, Ropes D. Are serious video games something more than a game? A review on the effectiveness of serious games to facilitate intergenerational learning. Educ Inf Technol. 2014;19:515–29.CrossRef
36.
go back to reference Sterkenburg PS, Vacaru VS. The effectiveness of a serious game to enhance empathy for care workers for people with disabilities: a parallel randomized controlled trial. Disabil Health J. 2018;11:576–82.CrossRef Sterkenburg PS, Vacaru VS. The effectiveness of a serious game to enhance empathy for care workers for people with disabilities: a parallel randomized controlled trial. Disabil Health J. 2018;11:576–82.CrossRef
37.
go back to reference Davis MH. A multidimensional approach to individual differences in empathy. JSAS Cat Sel Doc Psychol. 1980;10:1–18. Davis MH. A multidimensional approach to individual differences in empathy. JSAS Cat Sel Doc Psychol. 1980;10:1–18.
38.
go back to reference Fogarty GJ, Bramston P. Validation of the Lifestress Inventory for People with Mild Intellectual Handicap. Res Dev Disabil. 1997;18(6):435–56. Fogarty GJ, Bramston P. Validation of the Lifestress Inventory for People with Mild Intellectual Handicap. Res Dev Disabil. 1997;18(6):435–56.
39.
go back to reference Kreidler SM, Muller KE, Grunwald GK, Ringham BM, Coker-Dukowithz ZT, Sakhadeo UR, et al. GLIMMPSE: online power computation for linear models with and without a baseline covariate. J Stat Softw. 2013;54:380–92.CrossRef Kreidler SM, Muller KE, Grunwald GK, Ringham BM, Coker-Dukowithz ZT, Sakhadeo UR, et al. GLIMMPSE: online power computation for linear models with and without a baseline covariate. J Stat Softw. 2013;54:380–92.CrossRef
40.
go back to reference Bowlby J. Attachment and loss: retrospect and prospect. Am J Orthop. 1982;52:664–78.CrossRef Bowlby J. Attachment and loss: retrospect and prospect. Am J Orthop. 1982;52:664–78.CrossRef
41.
go back to reference Cummins RA, Lau ALD. Personal Wellbeing Index—School Children (PWI-SC) (Cantonese). 3rd ed. Victoria; 2005. Cummins RA, Lau ALD. Personal Wellbeing Index—School Children (PWI-SC) (Cantonese). 3rd ed. Victoria; 2005.
42.
go back to reference Cummins RA, Lau ALD. Personal Wellbeing Index: Pre-school. Burwood: Deakin University; 2005. Cummins RA, Lau ALD. Personal Wellbeing Index: Pre-school. Burwood: Deakin University; 2005.
43.
go back to reference Seys DM. Kwaliteit van zorg: zorg voor kwaliteit. Nijmegen: Katholieke Universiteit Nijmegen; 1987. Seys DM. Kwaliteit van zorg: zorg voor kwaliteit. Nijmegen: Katholieke Universiteit Nijmegen; 1987.
44.
go back to reference Janssen MJ, Riksen-Walraven JM, Van Dijk JPM. Enhancing the quality of interaction between deafblind children and their educators. J Dev Phys Disabil. 2002;14:87–109.CrossRef Janssen MJ, Riksen-Walraven JM, Van Dijk JPM. Enhancing the quality of interaction between deafblind children and their educators. J Dev Phys Disabil. 2002;14:87–109.CrossRef
45.
go back to reference Jonker D, Sterkenburg PS, Van Rensburg E. Caregiver-mediated therapy for an adult with visual and intellectual impairment suffering from separation anxiety. Res Dev Disabil. 2015;47:1–13.CrossRef Jonker D, Sterkenburg PS, Van Rensburg E. Caregiver-mediated therapy for an adult with visual and intellectual impairment suffering from separation anxiety. Res Dev Disabil. 2015;47:1–13.CrossRef
46.
go back to reference Allison C, Auyeung B, Baron-Cohen S. Toward brief “red flags” for autism screening: the short Autism Spectrum Quotient and the short Quantitative Checklist in 1,000 cases and 3,000 controls. J Am Acad Child Adolesc Psychiatry. 2012;51:202–12.CrossRef Allison C, Auyeung B, Baron-Cohen S. Toward brief “red flags” for autism screening: the short Autism Spectrum Quotient and the short Quantitative Checklist in 1,000 cases and 3,000 controls. J Am Acad Child Adolesc Psychiatry. 2012;51:202–12.CrossRef
47.
go back to reference Booth T, Murray AL, McKenzie K, Kuenssberg R, O’Donnell M, Burnett H. Brief report: An evaluation of the AQ-10 as a brief screening instrument for ASD in adults. J Autism Dev Disord. 2013;43:2997–3000.CrossRef Booth T, Murray AL, McKenzie K, Kuenssberg R, O’Donnell M, Burnett H. Brief report: An evaluation of the AQ-10 as a brief screening instrument for ASD in adults. J Autism Dev Disord. 2013;43:2997–3000.CrossRef
48.
go back to reference Fonagy P, Luyten P, Moulton-perkins A, Lee Y, Warren F, Howard S, et al. Development and validation of a self-report measure of mentalizing: the Reflective Functioning Questionnaire. PLoS One. 2016;11:1–28.CrossRef Fonagy P, Luyten P, Moulton-perkins A, Lee Y, Warren F, Howard S, et al. Development and validation of a self-report measure of mentalizing: the Reflective Functioning Questionnaire. PLoS One. 2016;11:1–28.CrossRef
49.
go back to reference Langner O, Dotsch R, Bijlstra G, Wigboldus DHJ, Hawk ST, Van Knippenberg A. Presentation and validation of the Radboud Faces Database. Cogn Emot. 2010;24:1377–88.CrossRef Langner O, Dotsch R, Bijlstra G, Wigboldus DHJ, Hawk ST, Van Knippenberg A. Presentation and validation of the Radboud Faces Database. Cogn Emot. 2010;24:1377–88.CrossRef
50.
go back to reference De Corte K, Buysse A, Verhofstadt L, Roeyers H, Ponnet K, Davis MH. Measuring empathic tendencies: reliability and validity of the Dutch version of the Interpersonal Reactivity Index. Psychol Belg. 2014;47:235–60.CrossRef De Corte K, Buysse A, Verhofstadt L, Roeyers H, Ponnet K, Davis MH. Measuring empathic tendencies: reliability and validity of the Dutch version of the Interpersonal Reactivity Index. Psychol Belg. 2014;47:235–60.CrossRef
51.
go back to reference Michie AM, Lindsay WR. A treatment component designed to enhance empathy in sex offenders with an intellectual disability. Br J Forensic Pract. 2012;14:40–8.CrossRef Michie AM, Lindsay WR. A treatment component designed to enhance empathy in sex offenders with an intellectual disability. Br J Forensic Pract. 2012;14:40–8.CrossRef
52.
go back to reference Abell F, Happé F, Frith U. Do triangles play tricks? Attribution of mental states to animated shapes in normal and abnormal development. Cogn Dev. 2000;15:1–16.CrossRef Abell F, Happé F, Frith U. Do triangles play tricks? Attribution of mental states to animated shapes in normal and abnormal development. Cogn Dev. 2000;15:1–16.CrossRef
53.
go back to reference Bandura A. Guidelines for constructing self-efficacy scales. In: Pajares F, Urdan T, editors. Self-efficacy, beliefs of adolescents. Charlotte: Information Age Publishing; 2006. p. 307–37. Bandura A. Guidelines for constructing self-efficacy scales. In: Pajares F, Urdan T, editors. Self-efficacy, beliefs of adolescents. Charlotte: Information Age Publishing; 2006. p. 307–37.
54.
go back to reference De Freitas S, Oliver M. How can exploratory learning with games and simulations within the curriculum be most effectively evaluated? Comput Educ. 2006;46:249–64.CrossRef De Freitas S, Oliver M. How can exploratory learning with games and simulations within the curriculum be most effectively evaluated? Comput Educ. 2006;46:249–64.CrossRef
55.
go back to reference Woittiez I, Putman L, Eggink E, Ras M, Sterkenburg PS. Zorg Beter Begrepen. Den Haag: Sociaal en Cultureel Planbureau; 2014. p. 128. Woittiez I, Putman L, Eggink E, Ras M, Sterkenburg PS. Zorg Beter Begrepen. Den Haag: Sociaal en Cultureel Planbureau; 2014. p. 128.
56.
go back to reference Mulhall P, Taggart L, Coates V, McAloon T, Hassiotis A. A systematic review of the methodological and practical challenges of undertaking randomised-controlled trials with cognitive disability populations. Soc Sci Med. 2018;200:114–28.CrossRef Mulhall P, Taggart L, Coates V, McAloon T, Hassiotis A. A systematic review of the methodological and practical challenges of undertaking randomised-controlled trials with cognitive disability populations. Soc Sci Med. 2018;200:114–28.CrossRef
57.
go back to reference Moonen XMH. (H)erkennen en waarderen: Over het (h)erkennen van de noden mensen met licht verstandelijke beperkingen en het bieden van passende ondersteuning. Amsterdam: Universiteit van Amsterdam; 2017. Moonen XMH. (H)erkennen en waarderen: Over het (h)erkennen van de noden mensen met licht verstandelijke beperkingen en het bieden van passende ondersteuning. Amsterdam: Universiteit van Amsterdam; 2017.
Metadata
Title
Effectiveness of the serious game ‘You & I’ in changing mentalizing abilities of adults with mild to borderline intellectual disabilities: a parallel superiority randomized controlled trial
Authors
Suzanne Derks
Suze van Wijngaarden
Mirjam Wouda
Carlo Schuengel
Paula S. Sterkenburg
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3608-9

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue