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

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.

SUBMITTER: Hypher RE

PROVIDER: S-EPMC6688684 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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

Hypher Ruth Elizabeth RE Brandt Anne Elisabeth AE Risnes Kari K Rø Torstein Baade TB Skovlund Eva E Andersson Stein S Finnanger Torun Gangaune TG Stubberud Jan J

BMJ open 20190801 8

<h4>Introduction</h4>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 effic ...[more]

PMID: 31375619

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Project description:BackgroundApproximately 1 million individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Many trauma survivors with mild TBI have debilitating and long-term physical, emotional, and cognitive impairments that are unrecognized at trauma centers. Early intervention studies are needed to address these impairments, especially cognitive deficits in executive functioning. Goal management training (GMT) is a structured cognitive rehabilitation program that has been found to improve executive functioning in patients with moderate to severe TBI. The current study adapted the GMT program for telephone delivery in order to improve the accessibility of rehabilitation services in a patient population with multiple barriers to care and significant yet unrecognized cognitive impairment. The primary objective of this study is to examine the efficacy of telephone-based GMT for improving executive functioning, functional status, and psychological health in trauma survivors with mild TBI.Methods/designThis study is a three-group randomized controlled trial being conducted at a Level I trauma center. Ninety trauma survivors with mild TBI and cognitive deficits in executive functioning will be randomized to receive telephone-based GMT, telephone-based education, or usual care. GMT and education programs will be delivered by a physical therapist. The first in-person session is 1 h and the remaining six telephone sessions are 30 min. A battery of well-established cognitive tests will be conducted and validated questionnaires will be collected that measure executive functioning, functional status, and depressive and posttraumatic stress disorder symptoms at 6 weeks, 4 months, and 7 months following hospital discharge.DiscussionThis study supports a telephone-delivery approach to rehabilitation services in order to broaden the availability of evidence-based cognitive strategies.Trial registrationThis trial was registered with Clinicaltrials.gov on 10 October 2012, registration number: NCT01714531.

Project description:INTRODUCTION:Childhood inattention has been linked with poor academic outcomes, and increased lifetime social, occupational and psychiatric morbidity. Children with an acquired brain injury (ABI) are particularly susceptible to attention deficits and may benefit from interventions aimed at enhancing attention. The primary objective of this study is to evaluate the short-term efficacy of the TALI Train programme, compared with a placebo, on the outcome of attention in children with ABI. METHODS AND ANALYSIS:The study is a parallel, double-blind, randomised controlled trial. Participants will consist of 80 children with a diagnosis of ABI aged 4-9 years 11 months. Participants will be randomly allocated to either (1) TALI Train (intervention group), an adaptive game-based attention training programme, or (2) a non-adaptive placebo programme (control group). Both programmes are delivered on a touchscreen tablet, and children complete five 20 min sessions per week for a 5-week period at home. Assessment of selective, sustained and executive attention (primary outcomes), and behavioural attention, working memory, social skills and mathematics ability (secondary outcomes) will occur at baseline, post-training, and at 3-month and 6-month follow-up to assess immediate and long-term efficacy of TALI Train compared with placebo. Assessments will be completed at the Royal Children's Hospital in Melbourne, Australia. All assessments and analyses will be undertaken by researchers blinded to group membership. Latent growth curve modelling will be employed to examine primary and secondary outcomes. ETHICS AND DISSEMINATION:Ethics approval has been obtained from the Royal Children's Hospital Human Research Ethics Committee (HREC) (38132) and the Monash University HREC (17446). Results will be disseminated through peer-reviewed journals, conference presentations, media outlets, the internet and various community/stakeholder activities. TRIAL REGISTRATION NUMBER:ACTRN12619000511134.

Project description:IntroductionCardiac surgery-associated acute kidney injury (CS-AKI) occurs in up to 40%~60% of paediatric patients and increases postoperative morbidity and mortality. A goal-directed perfusion (GDP) strategy aimed at maintaining indexed oxygen delivery (DO2i) above the critical threshold (reported to be 260~300 mL/min/m2 in adults) during cardiopulmonary bypass (CPB), is effective in reducing the incidence of CS-AKI. However, no clear standards of paediatric critical DO2i exist. Our prior prospective cohort study exploring the critical DO2i threshold during paediatric CPB has found the nadir DO2i <353 mL/min/m2 was an independent risk predictor of CS-AKI. Based on this background, this trial is designed to further determine whether the implementation of the GDP initiative aimed at maintaining DO2i ≥360 mL/min/m2 would reduce the rate of CS-AKI in paediatrics and improve clinical outcome.Methods and analysisThis is a prospective, single-centre, randomised controlled trial. In total, 166 paediatric patients undergoing cardiac surgery will be randomly allocated to the GDP group or control group. Patients in the GDP arm will be treated with a GDP strategy during CPB aimed to maintain DO2i at ≥360 mL/min/m2 (to ensure safely above the risk DO2i threshold we found). The perfusion strategy for patients in the control arm will be factored on body surface area and temperature. The primary outcome is the rate of postoperative CS-AKI (it is defined according to paediatric Risk, Injury, Failure, Loss of renal function and End-stage renal disease criteria). The secondary end points include: (1) the other oxygen metabolism parameters during CPB; (2) major complication and all-cause mortality (in-hospital or within 30 days postoperatively); (3) short-term clinical outcomes (ie, time to extubation, mechanical ventilation time, hospital stay).Ethics and disseminationThe study has been approved by the Biomedical Research Ethics committee of West China Hospital of Sichuan University (approval number: 2019(863)). Results will be disseminated through peer-reviewed publications and conferences.Trial registration numberChiCTR2000029232.

Project description:BackgroundTraumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.Methods/designThe erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine whether the administration of erythropoietin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at six months after injury. The trial is designed to recruit 606 patients between 15 and 65 years of age with severe (Glasgow Coma Score: 3 to 8) or moderate (Glasgow Coma Score: 9 to 12) traumatic brain injury in Australia, New Zealand, Kingdom of Saudi Arabia, France, Finland, Germany and Ireland. Trial patients will receive either subcutaneous erythropoietin or placebo within 24 hours of injury, and weekly thereafter for up to three doses during the intensive care unit admission. The primary outcome will be the combined proportion of unfavourable neurological outcomes at six months: severe disability or death. Secondary outcomes will include the rate of proximal deep venous thrombosis detected by compression Doppler ultrasound, six-month mortality, the proportion of patients with composite vascular events (deep venous thrombosis, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at six months and quality of life with health economic evaluations.DiscussionWhen completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition.Trial registrationAustralian New Zealand Clinical Trials registry: ACTRN12609000827235 (registered on 22 September 2009). Clinicaltrials.gov: NCT00987454 (registered on 29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (registered on 18 January 2012).

Project description:IntroductionSocial communication difficulties (SCDs) occur frequently after an acquired brain injury (ABI) and have disabling consequences, but effective interventions are scant. Group Interactive Structured Treatment (GIST) is a holistic group treatment targeting SCD that has received empirical support.ObjectiveTo determine the efficacy of two GIST protocols, standard GIST and a newly developed intensive GIST, comparing standard GIST results to a wait-list control group (WL), as well as to intensive GIST received by participants following WL. The within subject results for WL and intensive GIST will also be examined.Methods and analysisSixty adults (18-75 years) with SCD after ABI will be recruited for this randomised controlled trial. Standard GIST (n=30) will be delivered via outpatient sessions for 2.5 hours once per week for 12 weeks, plus one initial orientation session. Participants will be assessed at preintervention and postintervention and at 3-month and 6-month follow-ups (T1-T4). Intensive GIST (n=30) participants will be admitted to an inpatient rehabilitation unit for 4 weeks (two times 3 days/week, two times 4 days/week) and receive full-day sessions each week. Those participants will complete four assessments (T1-T4) in 12-week intervals as part of WL, assessments preintensive and postintensive GIST and at 3-month and 6-month follow-ups (T4-T7). The primary outcome measure is the La Trobe Questionnaire (self-report). Secondary outcome measures include the Profile of Pragmatic Impairment in Communication, a test of emotion recognition, the Goal Attainment Scale and questionnaires addressing social, emotional and cognitive functions, self-efficacy and quality of life.Ethics and disseminationResults will be communicated through international, peer-reviewed and popular science journals and presentations at scientific conferences. The study is approved by the Regional Committees for Medical and Health Research Ethics Norway (2017/1360). The trial will be conducted in accordance with the Declaration of Helsinki and reported in accordance with the Consolidated Standards of Reporting Trials 2010 statement and Standard Protocol Items: Recommendations for Interventional Trials recommendations.Trial registration numberNCT03636399.

Project description:IntroductionThe sequelae of moderate-severe acquired brain injury (ABI) encompass motor, cognitive, sensory, emotional and behavioural areas that affect meaningful occupational participation and quality of life, with a high prevalence of associated mental disorders. When the patient returns to community life after discharge from the hospital, specialised care is generally insufficient due to the lack of consideration of the dual condition of mental disorder and ABI. Since there is a negative impact on competence and thus on occupational participation, occupational therapy represents a convenient way of intervention. On these assumptions, a community-based occupational therapy protocol on mental health for people with moderate/severe acquired brain injury (COT-MHABI) is presented. It is focused on meaningful occupational participation and looks for improvement in the quality of life.Methods and analysisThis study aims: (i) to design a protocol to evaluate the effectiveness of a community occupational therapy intervention based on MOHO for patients with a dual (mental health/ABI) for improving quality of life and self-perceived occupational performance; (ii) to analyse the outcomes of occupational and social variables (occupational balance, participation level, satisfaction with occupation and performed roles and community integration) after the COT-MHABI process; (iii) to analyse the impact of quality of life on satisfaction with occupations performed by this population. A non-randomised controlled clinical trial will be performed. Patients assigned to the experimental group will receive over one year of on-site and telematic occupational therapy sessions, 16 sessions on average. Variables such as quality of life, community integration or satisfaction with occupational performance will be collected at baseline, 6, and 12 months.DiscussionThe needs for the dual mental/ABI population in their reintegration into the community are related to the associated deficits and to the absence of specialised services for the complexity of this patient profile. Few studies consider the coexistence of mental health and ABI issues. The COT-MHABI protocol is proposed to provide continuity to the community needs of this population, conceptualised from occupational participation, person-centred and focused on meaningful activities.Clinical trial registrationTrial identifier and registry name ClinicalTrials.gov ID: NCT04586842 https://clinicaltrials.gov/ct2/show/NCT04586842?term=252136&draw=2&rank=1; Pre-results; Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury (COT-MHABI).

Dataset Information

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

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

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