Parental support for children with allergies (PASCAL study): a randomised controlled trial of the effectiveness of a self-help website for parents of children with food allergy

Abstract

Background The impact of caring for a child with food allergy (FA) on parental quality of life (QoL) is well documented. Recent studies have provided support for the importance of self-efficacy (SE) in increasing QoL for these parents. Despite evidence that traditional psychological interventions (e.g. Cognitive Behavioural Therapy) can increase SE, there is little research examining the effect of web-based or self-help interventions. This study aimed to examine the acceptability and effectiveness of a self-help website on parental QoL. Method This was a single blinded randomised controlled trial of a self-help website for parents of children with FA recruited via social media. Participants completed outcome measures (Food Allergy Quality of Life-Parental Burden (FAQL-PB), depression, anxiety, stress, intolerance of uncertainty and SE) via an online system before being randomised to the intervention arm (immediate access to the self-help website) or waiting list control. Outcomes were measured at baseline, 1- and 3-months. The data reported here relate to the 1-month post-intervention assessment (clinicaltrial.gov identifier NCT03529747). Results A total of 205 participants (112=intervention, 93=control) completed baseline measures (97% female, mean age 38.95 years (SD=6.89)) of which 102 participants (49.8%) completed 1-month outcomes. There were no significant differences at baseline indicating successful randomisation (all ps<.001). Independent t-tests on pre- and post-intervention change scores showed no significant differences on outcomes at 1-month. Conclusion This study reports the 1-month data of a randomised controlled trial of a self-help website for parents of children with FA. The website addressed important areas identified by a patient and public involvement group of parents with children with FA such as clear definitions, recognitions of symptoms and management including access to plans and a technique for managing anxious thoughts. It may be that balancing the desire for a website which was simple, brief with accessible information rather than a website which was more comprehensive resulted in the lack of significant main effects at 1-month. Analysis of longer term follow-up (3-months) and participant feedback in terms of how often the website was accessed and utility of the information provided will enable a deeper understanding of these results