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Randomized Controlled Trial
. 2015 Dec 29;5(12):e009581.
doi: 10.1136/bmjopen-2015-009581.

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

Lorraine C Als  1 , Simon Nadel  2 , Mehrengise Cooper  2 , Bea Vickers  3 , M Elena Garralda  1
Affiliations
Randomized Controlled Trial

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

Lorraine C Als et al. BMJ Open. .

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).

Design: 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.

Setting: A PICU in an acute care hospital in London, UK.

Participants: 31 parents of children aged 4-16 years-old admitted to PICU.

Intervention: 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.

Main outcome measures: 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.

Trials registration number: NCT01737021; Results.

Keywords: Clinical trials < THERAPEUTICS; MENTAL HEALTH.

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Figures

Figure 1
Figure 1
Participant flow chart. PICU,Paediatric Intensive Care Unit.
See this image and copyright information in PMC

References

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