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

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.

Study Overview

• Status: Completed
• Conditions: The Well Being of Parents of Children With Food Allergies
• Intervention / Treatment: Other: Online self-help

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 Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Tunbridge Wells, Kent, United Kingdom, TN1 2YG
      • Salomons Centre for Applied Psychology, Canterbury Christ Church University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online self-help; A website providing information and psycho-education aimed at parents and carers of children with food allergies.	Other: Online self-help; As detailed in experimental arm description.
No Intervention: Wait list control; A waiting list control group, who will receive access to the online self-help once the RCT is complete.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline at 4-weeks on the Food Allergy Self-Efficacy Scale for Parents	This measures a parent's confidence in managing their child's food allergy, producing a score between 0 and 100, with higher scores indicating greater confidence.	Post-intervention (4-weeks after baseline)
Change from baseline at 8-weeks on the Food Allergy Self-Efficacy Scale for Parents	This measures a parent's confidence in managing their child's food allergy, producing a score between 0 and 100, with higher scores indicating greater confidence.	Follow-up (8-weeks after baseline)
Change from baseline at 4-weeks on the Intolerance of Uncertainty Scale	This measures participants' ability to tolerate uncertainty, producing scores between 27 and 135, with higher scores indicating lower tolerance of uncertainty.	Post-intervention (4-weeks after baseline)
Change from baseline at 8-weeks on the Intolerance of Uncertainty Scale	This measures participants' ability to tolerate uncertainty, producing scores between 27 and 135, with higher scores indicating lower tolerance of uncertainty.	Follow-up (8-weeks after baseline)

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University
• Collaborators: Brighton & Sussex Medical School
• Investigators: Principal Investigator: Naomi Sugunasingha, BSc, PGCert, Canterbury Christ Church University; Study Director: Christina Jones, PhD, Brighton & Sussex Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): February 4, 2019
• Study Completion (Actual): February 4, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: NaomiSugunasinghaMRP2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No