title: Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  People with aphasia and their family members are at high risk of experiencing post stroke depression. The impact of early interventions on mood and quality of life for people with aphasia is unknown.
  
  
  METHODS
  This study will determine whether an early intervention for both the person with aphasia after stroke and their family members leads to better mood and quality of life outcomes for people with aphasia, and less caregiver burden and better mental health for their family members. This is a multicenter, cluster-randomized controlled trial. Clusters, which are represented by Health Service Districts, will be randomized to the experimental intervention (Aphasia Action Success Knowledge Program) or an attention control (Secondary Stroke Prevention Information Program). People with aphasia and their family members will be blinded to the study design and treatment allocation (that is, will not know there are two arms to the study). Both arms of the study will receive usual care in addition to either the experimental or the attention control intervention. A total of 344 people with aphasia and their family members will be recruited. Considering a cluster size of 20, the required sample size can be achieved from 18 clusters. However, 20 clusters will be recruited to account for the potential of cluster attrition during the study. Primary outcome measures will be mood and quality of life of people with aphasia at 12 months post stroke. Secondary measures will be family member outcomes assessing the impact of caregiving and mental health, and self-reported stroke risk-related behaviors of people with aphasia.
  
  
  CONCLUSIONS
  This is the first known program tailored for people with aphasia and their family members that aims to prevent depression in people with aphasia by providing intervention early after the stroke.
  
  
  BACKGROUND
  This trial is registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) as ACTRN12614000979651 . Date registered: 11 September 2014.
authors.affiliation: National Health and Medical Research Council Centre for Clinical Research Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane, Australia.|School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.
authors.forename: Linda
authors.initials: L
authors.lastname: Worrall
authors.affiliation: National Health and Medical Research Council Centre for Clinical Research Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane, Australia. brooke.ryan@uq.edu.au.|School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia. brooke.ryan@uq.edu.au.
authors.forename: Brooke
authors.initials: B
authors.lastname: Ryan
authors.affiliation: National Health and Medical Research Council Centre for Clinical Research Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane, Australia.|School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.
authors.forename: Kyla
authors.initials: K
authors.lastname: Hudson
authors.affiliation: Discipline of Clinical Psychology, University of Technology, Sydney, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Kneebone
authors.affiliation: National Health and Medical Research Council Centre for Clinical Research Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane, Australia.|Southeastern Louisiana University, Hammond, Louisiana, USA.
authors.forename: Nina
authors.initials: N
authors.lastname: Simmons-Mackie
authors.affiliation: School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.
authors.forename: Asaduzzaman
authors.initials: A
authors.lastname: Khan
authors.affiliation: School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.|Centre for Research in Evidence-Based Practice, Bond University, Gold Coast, Australia.
authors.forename: Tammy
authors.initials: T
authors.lastname: Hoffmann
authors.affiliation: National Health and Medical Research Council Centre for Clinical Research Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane, Australia.|Speech Pathology, Faculty of Health Sciences, The University of Sydney, Sydney, Australia.
authors.forename: Emma
authors.initials: E
authors.lastname: Power
authors.affiliation: National Health and Medical Research Council Centre for Clinical Research Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane, Australia.|Speech Pathology, Faculty of Health Sciences, The University of Sydney, Sydney, Australia.
authors.forename: Leanne
authors.initials: L
authors.lastname: Togher
authors.affiliation: National Health and Medical Research Council Centre for Clinical Research Excellence in Aphasia Rehabilitation (NHMRC CCRE-Aphasia), Brisbane, Australia.|School of Allied Health, La Trobe University, Melbourne, Australia.
authors.forename: Miranda
authors.initials: M
authors.lastname: Rose
mesh_terms: D000339:Affect; D001037:Aphasia / Q000175:diagnosis / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D001315:Australia; D017028:Caregivers / Q000523:psychology*; D002985:Clinical Protocols; D016000:Cluster Analysis; D017281:Cost of Illness; D003863:Depression / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D061345:Early Medical Intervention; D005195:Family Relations; D006801:Humans; D008603:Mental Health; D011788:Quality of Life; D012107:Research Design; D020521:Stroke / Q000150:complications / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D000071939:Stroke Rehabilitation; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Aphasia; Cluster randomized controlled trial; Depression; Mood; Prevention; Quality of life; Rehabilitation