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

The Well Being of Parents of Children With Food Allergies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529747
• Other study ID #: NaomiSugunasinghaMRP2017
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: February 4, 2019

Study information

• Verified date: October 2019
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity
• The Well Being of Parents of Children With Food Allergies

Intervention

Other:
• Online self-help
As detailed in experimental arm description.

Locations

Country	Name	City	State
United Kingdom	Salomons Centre for Applied Psychology, Canterbury Christ Church University	Tunbridge Wells	Kent

Sponsors (2)

Lead Sponsor	Collaborator
Canterbury Christ Church University	Brighton & Sussex Medical School

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)