Paediatric goal management training in patients with acquired brain injury: study protocol for a randomised controlled trial

Ruth Elizabeth Hypher, Anne Elisabeth Brandt, Kari Risnes, Torstein Baade Rø, Eva Skovlund, Stein Andersson, Torun Gangaune Finnanger, Jan Stubberud, Ruth Elizabeth Hypher, Anne Elisabeth Brandt, Kari Risnes, Torstein Baade Rø, Eva Skovlund, Stein Andersson, Torun Gangaune Finnanger, Jan Stubberud

Abstract

Introduction: Compromised integrity of the brain due to paediatric acquired brain injury (pABI) has been associated with cognitive impairment, particularly executive dysfunction, in addition to somatic and emotional symptoms and reduced everyday function. Goal Management Training (GMT) is a cognitive rehabilitation intervention for improving executive function (EF) that has received empirical support in studies of adults with ABI. The purpose of the present study is to determine the efficacy of a recently developed paediatric version of GMT (pGMT) for children and adolescents with ABI and reported executive dysfunction.

Methods and analysis: This study protocol describes a parallel randomised controlled trial including allocation concealment and assessor blinding. Eighty survivors after pABI, aged 10-17 years at the time of intervention, will be recruited. Participants will be randomly allocated to either pGMT (n=40) or a psychoeducative control intervention (n=40; paediatric Brain Health Workshop). Both interventions consist of seven group sessions for participants and parents, followed by external cueing and telephone counselling. The study also includes involvement of teachers. Assessments will be performed at baseline, immediately postintervention and at 6 months' follow-up. Primary outcome measure will be changes in daily life EF as reported by parents (The Behavior Rating Inventory of Executive Function). Secondary outcomes include other assessments of EF (neuropsychological tests and questionnaires). Furthermore, we aim to assess generalisation effects of pGMT on other cognitive functions, as well as emotional, behavioural, adaptive and family function, academic performance, fatigue and quality of life.

Ethics and dissemination: Results from this study will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals, in addition to presentations at scientific conferences. The study will be conducted in accordance with the Helsinki declaration and the Ethical Research Involving Children (ChildWatch International and Unicef). In accordance to Good Clinical Practice our study includes safety and quality monitoring guarantees in compliance with research ethics and safety. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials 2010 statement and Standard Protocol Items for Reporting in Trials recommendations, in addition to being registered at ClinicalTrials.gov. The study has been approved by the Regional Committees for Medical and Health Research Ethics Norway (2017/772).

Trial registration number: NCT03215342.

Keywords: cognitive rehabilitation; executive functioning; goal management training; paediatric acquired brain injury.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study period illustrated by SPIRIT figure. BRIEF, Behavior Rating Inventory of Executive Functions; EF, executive function; pGMT, paediatric Goal Management Training; pBHW, paediatric Brain Health Workshop; SPIRIT, Standard Protocol Items for Reporting in Trials.
Figure 2
Figure 2
Flowchart for the study protocol. Cognitive Rehabilitation in paediatric ABI—a randomised controlled study. ABI, acquired brain injury; EF, executive function.
Figure 3
Figure 3
Description of the paediatric Goal Management Training and paediatric Brain Health Workshop interventions.

References

    1. Langlois JA, Rutland-Brown W, Thomas KE. The incidence of traumatic brain injury among children in the United States: differences by race. J Head Trauma Rehabil 2005;20:229–38. 10.1097/00001199-200505000-00006
    1. Organization WH World Health Statistics : Organization WH. Geneva, 2009.
    1. Anderson V, Catroppa C. Advances in postacute rehabilitation after childhood-acquired brain injury: a focus on cognitive, behavioral, and social domains. Am J Phys Med Rehabil 2006;85:767–78. 10.1097/01.phm.0000233176.08480.22
    1. Ryan NP, Anderson V, Godfrey C, et al. . Predictors of very-long-term sociocognitive function after pediatric traumatic brain injury: evidence for the vulnerability of the immature "social brain". J Neurotrauma 2014;31:649–57. 10.1089/neu.2013.3153
    1. Ponsford JL, Downing MG, Olver J, et al. . Longitudinal follow-up of patients with traumatic brain injury: outcome at two, five, and ten years post-injury. J Neurotrauma 2014;31:64–77. 10.1089/neu.2013.2997
    1. Anderson V, Catroppa C, Morse S, et al. . Recovery of intellectual ability following traumatic brain injury in childhood: impact of injury severity and age at injury. Pediatr Neurosurg 2000;32:282–90. 10.1159/000028956
    1. Beauchamp M, Anderson V. Cognitive and psychopathological sequelae of pediatric traumatic brain injury : Handbook of clinical neurology. Elsevier, 2013: 913–20.
    1. Catroppa C, Anderson V. Traumatic brain injury in childhood: rehabilitation considerations. Dev Neurorehabil 2009;12:53–61. 10.1080/17518420802634476
    1. Catroppa C, Anderson VA, Muscara F, et al. . Educational skills: long-term outcome and predictors following paediatric traumatic brain injury. Neuropsychol Rehabil 2009;19:716–32. 10.1080/09602010902732868
    1. Karver CL, Wade SL, Cassedy A, et al. . Age at injury and long-term behavior problems after traumatic brain injury in young children. Rehabil Psychol 2012;57:256–65. 10.1037/a0029522
    1. Li L, Liu J. The effect of pediatric traumatic brain injury on behavioral outcomes: a systematic review. Dev Med Child Neurol 2013;55:37–45. 10.1111/j.1469-8749.2012.04414.x
    1. Anderson V, Spencer-Smith M, Wood A. Do children really recover better? neurobehavioural plasticity after early brain insult. Brain 2011;134:2197–221. 10.1093/brain/awr103
    1. Klingberg T. Training and plasticity of working memory. Trends Cogn Sci 2010;14:317–24. 10.1016/j.tics.2010.05.002
    1. Ylvisaker M, Feeney T. Pediatric brain injury: social, behavioral, and communication disability. Phys Med Rehabil Clin N Am 2007;18:133–44. 10.1016/j.pmr.2006.11.007
    1. Ryan NP, van Bijnen L, Catroppa C, et al. . Longitudinal outcome and recovery of social problems after pediatric traumatic brain injury (TBI): contribution of brain insult and family environment. Int J Dev Neurosci 2016;49:23–30. 10.1016/j.ijdevneu.2015.12.004
    1. Max JE, Wilde EA, Bigler ED, et al. . Psychiatric disorders after pediatric traumatic brain injury: a prospective, longitudinal, controlled study. J Neuropsychiatry Clin Neurosci 2012;24:427–36. 10.1176/appi.neuropsych.12060149
    1. Levisohn L, Cronin-Golomb A, Schmahmann JD. Neuropsychological consequences of cerebellar tumour resection in children: cerebellar cognitive affective syndrome in a paediatric population. Brain 2000;123:1041–50. 10.1093/brain/123.5.1041
    1. Wilkinson J, Marmol NL, Godfrey C, et al. . Fatigue following paediatric acquired brain injury and its impact on functional outcomes: a systematic review. Neuropsychol Rev 2018;28:73–87. 10.1007/s11065-018-9370-z
    1. Zeltzer LK, Recklitis C, Buchbinder D, et al. . Psychological status in childhood cancer survivors: a report from the childhood cancer Survivor study. J Clin Oncol 2009;27:2396–404. 10.1200/JCO.2008.21.1433
    1. Anderson V, Catroppa C. Recovery of executive skills following paediatric traumatic brain injury (TBI): a 2 year follow-up. Brain Inj 2005;19:459–70. 10.1080/02699050400004823
    1. Anderson V, Catroppa C, Morse S, et al. . Attentional and processing skills following traumatic brain injury in early childhood. Brain Inj 2005;19:699–710. 10.1080/02699050400025281
    1. Michaeli O, Kassis I, Shachor-Meyouhas Y, et al. . Long-Term motor and cognitive outcome of acute encephalitis. Pediatrics 2014;133:e546–52. 10.1542/peds.2013-3010
    1. Stuss DT. Traumatic brain injury: relation to executive dysfunction and the frontal lobes. Curr Opin Neurol 2011;24:584–9. 10.1097/WCO.0b013e32834c7eb9
    1. Stuss DT. Functions of the frontal lobes: relation to executive functions. J Int Neuropsychol Soc 2011;17:759–65. 10.1017/S1355617711000695
    1. Levine B, Schweizer TA, O'Connor C, et al. . Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci 2011;5:9 10.3389/fnhum.2011.00009
    1. Stuss DT, Knight RT. Principles of frontal lobe function. Oxford University Press, 2002.
    1. Lewis MW, Babbage DR, Leathem JM. Assessing executive performance during cognitive rehabilitation. Neuropsychol Rehabil 2011;21:145–63. 10.1080/09602011.2010.543867
    1. Laatsch L, Harrington D, Hotz G, et al. . An evidence-based review of cognitive and behavioral rehabilitation treatment studies in children with acquired brain injury. J Head Trauma Rehabil 2007;22:248–56. 10.1097/01.HTR.0000281841.92720.0a
    1. Sohlberg MM, Harn B, MacPherson H, et al. . A pilot study evaluating attention and strategy training following pediatric traumatic brain injury. Clin Pract Pediatr Psychol 2014;2:263–80. 10.1037/cpp0000072
    1. Turner-Stokes L, Williams H, Bill A, et al. . Cost-efficiency of specialist inpatient rehabilitation for working-aged adults with complex neurological disabilities: a multicentre cohort analysis of a national clinical data set. BMJ Open 2016;6:e010238 10.1136/bmjopen-2015-010238
    1. Fountain DM, Burke GAA. Multidisciplinary rehabilitation for children with brain tumors: a systematic review. Dev Neurorehabil 2017;20:68–75. 10.3109/17518423.2015.1065017
    1. Hayes L, Shaw S, Pearce MS, et al. . Requirements for and current provision of rehabilitation services for children after severe acquired brain injury in the UK: a population-based study. Arch Dis Child 2017;102:813–20. 10.1136/archdischild-2016-312166
    1. Limond J, Leeke R. Practitioner review: cognitive rehabilitation for children with acquired brain injury. J Child Psychol Psychiatry 2005;46:339–52. 10.1111/j.1469-7610.2004.00397.x
    1. Robinson KE, Kaizar E, Catroppa C, et al. . Systematic review and meta-analysis of cognitive interventions for children with central nervous system disorders and neurodevelopmental disorders. J Pediatr Psychol 2014;39:846–65. 10.1093/jpepsy/jsu031
    1. Butler RW, Copeland DR, Fairclough DL, et al. . A multicenter, randomized clinical trial of a cognitive remediation program for childhood survivors of a pediatric malignancy. J Consult Clin Psychol 2008;76:367–78. 10.1037/0022-006X.76.3.367
    1. Galbiati S, Recla M, Pastore V, et al. . Attention remediation following traumatic brain injury in childhood and adolescence. Neuropsychology 2009;23:40–9. 10.1037/a0013409
    1. Luton LM, Reed-Knight B, Loiselle K, et al. . A pilot study evaluating an abbreviated version of the cognitive remediation programme for youth with neurocognitive deficits. Brain Inj 2011;25:409–15. 10.3109/02699052.2011.558044
    1. Sjö NM, Spellerberg S, Weidner S, et al. . Training of attention and memory deficits in children with acquired brain injury. Acta Paediatr 2010;99:230–6. 10.1111/j.1651-2227.2009.01587.x
    1. van 't Hooft I, Andersson K, Bergman B, et al. . Sustained favorable effects of cognitive training in children with acquired brain injuries. NeuroRehabilitation 2007;22:109–16.
    1. Lindsay S, Hartman LR, Reed N, et al. . A systematic review of Hospital-to-School reintegration interventions for children and youth with acquired brain injury. PLoS One 2015;10:e0124679 10.1371/journal.pone.0124679
    1. Cicerone KD, Langenbahn DM, Braden C, et al. . Evidence-Based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil 2011;92:519–30. 10.1016/j.apmr.2010.11.015
    1. Kennedy MRT, Coelho C, Turkstra L, et al. . Intervention for executive functions after traumatic brain injury: a systematic review, meta-analysis and clinical recommendations. Neuropsychol Rehabil 2008;18:257–99. 10.1080/09602010701748644
    1. Levine B, Robertson IH, Clare L, et al. . Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc 2000;6:299–312. 10.1017/S1355617700633052
    1. Spikman JM, Boelen DHE, Lamberts KF, et al. . Effects of a multifaceted treatment program for executive dysfunction after acquired brain injury on indications of executive functioning in daily life. J Int Neuropsychol Soc 2010;16:118–29. 10.1017/S1355617709991020
    1. Stamenova V, Levine B. Effectiveness of goal management training® in improving executive functions: a meta-analysis. Neuropsychol Rehabil 2018:1–31. 10.1080/09602011.2018.1438294
    1. Stubberud J, Langenbahn D, Levine B, et al. . Goal management training of executive functions in patients with spina bifida: a randomized controlled trial. J Int Neuropsychol Soc 2013;19:672–85. 10.1017/S1355617713000209
    1. Tornås S, Løvstad M, Solbakk A-K, et al. . Rehabilitation of executive functions in patients with chronic acquired brain injury with goal management training, external Cuing, and emotional regulation: a randomized controlled trial. J Int Neuropsychol Soc 2016;22:436–52. 10.1017/S1355617715001344
    1. Krasny-Pacini A, Chevignard M, Evans J. Goal management training for rehabilitation of executive functions: a systematic review of effectiveness in patients with acquired brain injury. Disabil Rehabil 2014;36:105–16. 10.3109/09638288.2013.777807
    1. Metzler-Baddeley C, Jones RW. Brief communication: cognitive rehabilitation of executive functioning in a case of craniopharyngioma. Appl Neuropsychol 2010;17:299–304. 10.1080/09084282.2010.523394
    1. Novakovic-Agopian T, Chen AJ-W, Rome S, et al. . Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil 2011;26:325–38. 10.1097/HTR.0b013e3181f1ead2
    1. Schweizer TA, Levine B, Rewilak D, et al. . Rehabilitation of executive functioning after focal damage to the cerebellum. Neurorehabil Neural Repair 2008;22:72–7. 10.1177/1545968307305303
    1. Miotto EC, Evans JJ, Souza de Lucia MC, et al. . Rehabilitation of executive dysfunction: a controlled trial of an attention and problem solving treatment group. Neuropsychol Rehabil 2009;19:517–40. 10.1080/09602010802332108
    1. Stubberud J, Langenbahn D, Levine B, et al. . Goal management training improves everyday executive functioning for persons with spina bifida: self-and informant reports six months post-training. Neuropsychol Rehabil 2014;24:26–60. 10.1080/09602011.2013.847847
    1. Stubberud J, Langenbahn D, Levine B, et al. . Emotional health and coping in spina bifida after goal management training: a randomized controlled trial. Rehabil Psychol 2015;60:1–16. 10.1037/rep0000018
    1. Tornås S, Løvstad M, Solbakk A-K, et al. . Goal management training combined with external cuing as a means to improve emotional regulation, psychological functioning, and quality of life in patients with acquired brain injury: a randomized controlled trial. Arch Phys Med Rehabil 2016;97:1841–52. 10.1016/j.apmr.2016.06.014
    1. Robertson IH, Garavan H. Vigilant attention : Gazzaniga MS, The cognitive neurosciences. Cambridge, MA: MIT Press, 2004: 631–40.
    1. Chen AJ-W, Novakovic-Agopian T, Nycum TJ, et al. . Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain 2011;134:1541–54. 10.1093/brain/awr067
    1. Stuss DT, Knight RT. Principles of frontal lobe function. Oxford University Press, 2013.
    1. Kabat-Zinn J. Full catastrophe living. New York: Dell Publishing, 1990.
    1. Krasny-Pacini A, Limond J, Evans J, et al. . Context-Sensitive goal management training for everyday executive dysfunction in children after severe traumatic brain injury. J Head Trauma Rehabil 2014;29:E49–64. 10.1097/HTR.0000000000000015
    1. Braga LW, Rossi L, Moretto ALL, et al. . Empowering preadolescents with ABI through metacognition: preliminary results of a randomized clinical trial. NeuroRehabilitation 2012;30:205–12. 10.3233/NRE-2012-0746
    1. Ylvisaker M, Adelson PD, Braga LW, et al. . Rehabilitation and ongoing support after pediatric TBI: twenty years of progress. J Head Trauma Rehabil 2005;20:95–109.
    1. Stubberud J, Holthe I, Løvstad M, et al. . Goal management training of executive functions inchildren with spina bifida and acquired brain injury: a pilot study. Neuropsychological Rehabilitation 2019. Under review.
    1. Organization WH Neurological disorders: public health challenges. World Health Organization, 2006.
    1. Anderson VA, Anderson P, Northam E, et al. . Relationships between cognitive and behavioral measures of executive function in children with brain disease. Child Neuropsychol 2002;8:231–40. 10.1076/chin.8.4.231.13509
    1. Gioia GA, Isquith PK, Guy SC, et al. . Behavior rating inventory of executive function: professional manual. Lutz, FL: Psychological Assessment Resources, Inc, 2000.
    1. Schulz KF, Altman DG, Moher D. Consort 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med 2010;8:18 10.1186/1741-7015-8-18
    1. Baber N. International Conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH). Br J Clin Pharmacol 1994;37:401–4. 10.1111/j.1365-2125.1994.tb05705.x
    1. Gjærum B. Hjerne og atferd: utviklingsforstyrrelser hos barn og ungdom i et nevrobiologisk perspektiv:-et skritt videre. Gyldendal Akademisk, 2002.
    1. Helseth E, Due-Tønnessen B, Lundar T, et al. . Intracranial tumors in children. Tidsskrift for den Norske laegeforening: tidsskrift for praktisk medicin, ny raekke 2003;123.
    1. Mallick AA, O'Callaghan FJK. The epidemiology of childhood stroke. Eur J Paediatr Neurol 2010;14:197–205. 10.1016/j.ejpn.2009.09.006
    1. HH Acute viral encephalitis in children: Pathogenesis, incidence, and etiology In: Morven MS, Armsby C, eds UpToDate, 2018.
    1. Chan DYK, Fong KNK. The effects of problem-solving skills training based on metacognitive principles for children with acquired brain injury attending mainstream schools: a controlled clinical trial. Disabil Rehabil 2011;33:2023–32. 10.3109/09638288.2011.556207
    1. Wechsler D. Wechsler intelligence scale for children. 5th edn TX, San Antonio: Psychological Corporation, 2014.
    1. Sørensen LH M. Psychometric properties of the Norwegian version of behavior rating inventory of executive function, parent version (BRIEF-P). PsykTestBarn 2014;2.
    1. Chevignard MP, Catroppa C, Galvin J, et al. . Development and evaluation of an ecological task to assess executive functioning post childhood TBI: the children's cooking task. Brain Impairment 2010;11:125–43. 10.1375/brim.11.2.125
    1. Chevignard MP, Servant V, Mariller A, et al. . Assessment of executive functioning in children after TBI with a naturalistic open-ended task: a pilot study. Dev Neurorehabil 2009;12:76–91. 10.1080/17518420902777019
    1. Fish J, Evans JJ, Nimmo M, et al. . Rehabilitation of executive dysfunction following brain injury: "content-free" cueing improves everyday prospective memory performance. Neuropsychologia 2007;45:1318–30. 10.1016/j.neuropsychologia.2006.09.015
    1. Manly T, Hawkins K, Evans J, et al. . Rehabilitation of executive function: facilitation of effective goal management on complex tasks using periodic auditory alerts. Neuropsychologia 2002;40:271–81. 10.1016/S0028-3932(01)00094-X
    1. Emslie H, Burden V, Nimmo-Smith I, et al. . Behavioural assessment of the dysexecutive syndrome for children: Thames Valley test company 2003.
    1. DuPaul GJ, Power TJ, Anastopoulos AD, et al. . Adhd rating Scale-IV (for children and adolescents): checklists, norms, and clinical interpretation. Guilford Publications, 1998.
    1. Conners C. Conners Continuous Performance Test 3rd edition™(Conners CPT 3™), Conners Continuous Auditory Test of Attention (Conners CATA™) manual. Toronto: Multi-Health Systems Inc, 2014.
    1. Delis DC, Kaplan E, Kramer JH. Delis-Kaplan executive function system: examiners manual. Psychological Corporation, 2001.
    1. Culbertson W, Zillmer E. Tower of London: Examiner’s manual. North Towanda, NY: Multi" Health Systems, 1999.
    1. Kløve H. Clinical neuropsychology. Med Clin North Am 1963;47:1647–58. 10.1016/S0025-7125(16)33515-5
    1. Delis DC. California verbal learning test. Adult version Manual Psychological Corporation, 2000.
    1. Achenbach TM. Child behavior checklist for ages 6– 18. Burlington: ASEBA. University of Vermont, 2001.
    1. Korkman M, Kirk U, Kemp S. NEPSY. 2nd edn San Antonio: TX: Psychological Corporation, 2007.
    1. Harter S. Manual for the self-perception profile for children:(revision of the perceived competence scale for children). University of Denver, 1985.
    1. Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care 1999;37:126–39. 10.1097/00005650-199902000-00003
    1. Ayr LK, Yeates KO, Taylor HG, et al. . Dimensions of postconcussive symptoms in children with mild traumatic brain injuries. J Int Neuropsychol Soc 2009;15:19–30. 10.1017/S1355617708090188
    1. Noller P, Seth-Smith M, Bouma R, et al. . Parent and adolescent perceptions of family functioning: a comparison of clinic and non-clinic families. J Adolesc 1992;15:101–14. 10.1016/0140-1971(92)90041-3
    1. Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1977;1:385–401.
    1. Beers SR, Wisniewski SR, Garcia-Filion P, et al. . Validity of a pediatric version of the Glasgow outcome Scale-Extended. J Neurotrauma 2012;29:1126–39. 10.1089/neu.2011.2272
    1. Wille N, Badia X, Bonsel G, et al. . Development of the EQ-5D-Y: a child-friendly version of the EQ-5D. Qual Life Res 2010;19:875–86. 10.1007/s11136-010-9648-y

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