title: A supported psychoeducational intervention to improve family mental health following discharge from paediatric intensive care: feasibility and pilot randomised controlled trial.
abstract: OBJECTIVE
  To assess feasibility and pilot a supported psychoeducational tool to improve parent and child mental health following discharge from a paediatric intensive care unit (PICU), in preparation for a large randomised controlled trial (RCT).
  
  
  METHODS
  Feasibility assessment and single-centre, parallel group, pilot RCT. A concealed computer generated list was used to randomise participants, with an allocation of 2:1 in favour of the intervention.
  
  
  METHODS
  A PICU in an acute care hospital in London, UK.
  
  
  METHODS
  31 parents of children aged 4-16 years-old admitted to PICU.
  
  
  METHODS
  Parents received a psychoeducational tool supported by a telephone call. The psychoeducational tool outlined the possible psychological reactions in children and parents alongside management advice. The telephone call addressed each family's postdischarge experience, reinforced the psychoeducational material and encouraged parents to put into practice the advice given.
  
  
  METHODS
  The primary outcome was the number of feasibility criteria successfully met (linked to the intervention and the study design). Secondary outcomes were questionnaire data collected at 3-6-month follow-up assessing mental health in parents and children.
  
  
  RESULTS
  31 parents were randomised (intervention n=22; treatment as usual, TAU n=9). 23 parents were included in the analysis of secondary outcomes (intervention n=17; TAU n=6). 3 (of 6) intervention and 1 (of 6) study design feasibility criteria were fully met. All unmet criteria could be addressed with minor or significant modifications to the protocol. At follow-up there was a tendency for parents who received the intervention to report lower post-traumatic stress symptoms in themselves and fewer emotional and behavioural difficulties in their children than TAU parents. This needs to be explored in a fully powered trial.
  
  
  CONCLUSIONS
  This feasibility and pilot RCT provided valuable information on the intervention and trial design for a full RCT.
  
  
  BACKGROUND
  NCT01737021; Results.
authors.affiliation: Centre for Mental Health, Imperial College London, London, UK.
authors.forename: Lorraine C
authors.initials: LC
authors.lastname: Als
authors.affiliation: Department of Paediatric Intensive Care, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK Department of Medicine, Imperial College London, London, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Nadel
authors.affiliation: Department of Paediatric Intensive Care, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK Department of Medicine, Imperial College London, London, UK.
authors.forename: Mehrengise
authors.initials: M
authors.lastname: Cooper
authors.affiliation: Adolescent Assertive Outreach Team, South West London and St George's Mental Health NHS Trust, London, UK.
authors.forename: Bea
authors.initials: B
authors.lastname: Vickers
authors.affiliation: Centre for Mental Health, Imperial College London, London, UK.
authors.forename: M Elena
authors.initials: ME
authors.lastname: Garralda
mesh_terms: D000293:Adolescent; D000328:Adult; D001007:Anxiety / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D003863:Depression / Q000628:therapy; D005192:Family Health / Q000193:education*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D015278:Intensive Care Units, Pediatric; D008131:London; D008297:Male; D008603:Mental Health / Q000193:education*; D008875:Middle Aged; D010290:Parents / Q000193:education / Q000523:psychology*; D010351:Patient Discharge; D010353:Patient Education as Topic / Q000379:methods*; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D013313:Stress Disorders, Post-Traumatic / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Clinical trials < THERAPEUTICS; MENTAL HEALTH