A supported psychoeducational intervention to improve family mental health following discharge from paediatric intensive care: feasibility and pilot randomised controlled trial

Abstract

ObjectiveTo 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).DesignFeasibility 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.SettingA PICU in an acute care hospital in London, UK.Participants31 parents of children aged 4–16 years-old admitted to PICU.InterventionParents 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.Main outcome measuresThe 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.Results31 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.ConclusionsThis feasibility and pilot RCT provided valuable information on the intervention and trial design for a full RCT.Trials registration numberNCT01737021; Results.

A review of interventions supporting parent's psychological well‐being after a child's intensive care unit discharge

“…These interventions were, however, provided at different time points, ranging from PICU admission (Melnyk et al, ) to within 7 days of discharge (Als et al . ) and 6 weeks after discharge (Gledhill et al, ) up to 2 months after discharge (Colville et al, ; Samuel et al, ) (Table ).…”

“…Als et al . () used an information intervention, similar to that described by Gledhill et al . () and Melnyk et al .…”

“…Studies varied in design, but all reported quantitative data (Table ). They included one full‐scale randomized controlled trial (RCT) (Melnyk et al, ), an exploratory RCT (Colville et al, ), a feasibility and pilot RCT (Als et al, ) and a feasibility study using a RCT design (Samuel et al, ). The remaining two studies used a non‐randomized design.…”

Neurologic Outcomes Following Care in the Pediatric Intensive Care Unit

“…In children, limited evidence suggests post-traumatic stress symptoms after PICU admission, including delusional memories, intrusive thoughts, and avoidance, occur in up to 32% of PICU survivors (18,23). Septic illness, increased numbers of invasive procedures, and benzodiazepines have been implicated as risk factors (18,89–92), and psychoeducational tools have been piloted with some success (12). Pediatric PICS is an important and rapidly growing area of research with results of ongoing multicenter studies expected to be published in the next few years (93).…”

Interventions to Reduce Psychologic Morbidity After PICU Discharge: Challenges to Establishing Efficacy*

“…Only 6 studies were identified that could be included in the review; three of these were reported as full randomized controlled trials (RCT) (3–5) and three as feasibility studies (6–8). Two of the feasibility studies also had RCT designs (6, 7) and one was an intervention without a control arm (8). Participants included parents and children.…”