Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies

Not Applicable

Completed

• Conditions: The Well Being of Parents of Children With Food Allergies
• Interventions: Other: Online self-help

• Registration Number: NCT03529747
• Lead Sponsor: Canterbury Christ Church University

Brief Summary

This study aims to conduct an initial evaluation of whether online self-help can improve the quality of life of parents of children with food allergies.

Detailed Description

This study is a pilot randomised controlled trial (RCT) comparing online self-help for parents of children with food allergies with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 4) and at follow-up (week 8).

Study Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-18
• Study Start: 2018-09-07
• Primary Completion: 2019-02-04
• Study Completion: 2019-02-04
• Status Verified: 2019-10
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Being a parent of at least one child (under the age of 18) who has a food allergy.
• Adequate understanding of written English.

Exclusion Criteria

• Having consulted on the design of the self-help website.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online self-help	Online self-help	A website providing information and psycho-education aimed at parents and carers of children with food allergies.

Primary Outcome Measures

Name	Time	Method
Change from baseline at 4-weeks on the Food Allergy Quality of Life Parental Burden scale	Post-intervention (4-weeks after baseline)	This measures parental burden when caring for a food-allergic child, producing a score between 17 and 119, with higher scores indicating greater burden.

Secondary Outcome Measures

Name	Time	Method
Change from baseline at 8-weeks on the Perceived Stress Scale (10 items)	Follow-up (8-weeks after baseline)	This produces a score between 0 and 40, with higher scores indicating higher levels of perceived stress.
Change from baseline at 8-weeks on the Patient Health Questionnaire depression scale 8	Follow-up (8-weeks after baseline)	This measures symptoms of depression, producing a score between 0 and 24, with higher scores indicating greater symptomatology.
Change from baseline at 4-weeks on the Generalised Anxiety Disorder 7 scale	Post-intervention (4-weeks after baseline)	This measures symptoms of generalised anxiety disorder, producing a score between 0 and 21, with higher scores indicating greater symptomatology.
Change from baseline at 8-weeks on the Generalised Anxiety Disorder 7 scale	Follow-up (8-weeks after baseline)	This measures symptoms of generalised anxiety disorder, producing a score between 0 and 21, with higher scores indicating greater symptomatology.
Change from baseline at 8-weeks on the Food Allergy Quality of Life Parental Burden scale	Follow-up (8-weeks after baseline)	This measures parental burden when caring for a food-allergic child, producing a score between 17 and 119, with higher scores indicating greater burden.
Change from baseline at 4-weeks on the Patient Health Questionnaire depression scale 8	Post-intervention (4-weeks after baseline)	This measures symptoms of depression, producing a score between 0 and 24, with higher scores indicating greater symptomatology.
Change from baseline at 4-weeks on the Perceived Stress Scale (10 items)	Post-intervention (4-weeks after baseline)	This produces a score between 0 and 40, with higher scores indicating higher levels of perceived stress.

Trial Locations

Locations (1)

Salomons Centre for Applied Psychology, Canterbury Christ Church University; 🇬🇧 Tunbridge Wells, Kent, United Kingdom