Back to resultsExploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
Primary Purpose
The Well Being of Parents of Children With Food Allergies
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Online self-help
Sponsored by
About this trial
This is an interventional supportive care trial for The Well Being of Parents of Children With Food Allergies
Eligibility Criteria
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.
Sites / Locations
- Salomons Centre for Applied Psychology, Canterbury Christ Church University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Online self-help
Wait list control
Arm Description
A website providing information and psycho-education aimed at parents and carers of children with food allergies.
A waiting list control group, who will receive access to the online self-help once the RCT is complete.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03529747
First Posted
May 8, 2018
Last Updated
August 19, 2020
Sponsor
Canterbury Christ Church University
Collaborators
Brighton & Sussex Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03529747
Brief Title
Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
Official Title
Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canterbury Christ Church University
Collaborators
Brighton & Sussex Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Well Being of Parents of Children With Food Allergies
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online self-help
Arm Type
Experimental
Arm Description
A website providing information and psycho-education aimed at parents and carers of children with food allergies.
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
A waiting list control group, who will receive access to the online self-help once the RCT is complete.
Intervention Type
Other
Intervention Name(s)
Online self-help
Intervention Description
As detailed in experimental arm description.
Primary Outcome Measure Information:
Title
Change from baseline at 4-weeks on the Food Allergy Quality of Life Parental Burden scale
Description
This measures parental burden when caring for a food-allergic child, producing a score between 17 and 119, with higher scores indicating greater burden.
Time Frame
Post-intervention (4-weeks after baseline)
Secondary Outcome Measure Information:
Title
Change from baseline at 8-weeks on the Food Allergy Quality of Life Parental Burden scale
Description
This measures parental burden when caring for a food-allergic child, producing a score between 17 and 119, with higher scores indicating greater burden.
Time Frame
Follow-up (8-weeks after baseline)
Title
Change from baseline at 4-weeks on the Patient Health Questionnaire depression scale 8
Description
This measures symptoms of depression, producing a score between 0 and 24, with higher scores indicating greater symptomatology.
Time Frame
Post-intervention (4-weeks after baseline)
Title
Change from baseline at 8-weeks on the Patient Health Questionnaire depression scale 8
Description
This measures symptoms of depression, producing a score between 0 and 24, with higher scores indicating greater symptomatology.
Time Frame
Follow-up (8-weeks after baseline)
Title
Change from baseline at 4-weeks on the Generalised Anxiety Disorder 7 scale
Description
This measures symptoms of generalised anxiety disorder, producing a score between 0 and 21, with higher scores indicating greater symptomatology.
Time Frame
Post-intervention (4-weeks after baseline)
Title
Change from baseline at 8-weeks on the Generalised Anxiety Disorder 7 scale
Description
This measures symptoms of generalised anxiety disorder, producing a score between 0 and 21, with higher scores indicating greater symptomatology.
Time Frame
Follow-up (8-weeks after baseline)
Title
Change from baseline at 4-weeks on the Perceived Stress Scale (10 items)
Description
This produces a score between 0 and 40, with higher scores indicating higher levels of perceived stress.
Time Frame
Post-intervention (4-weeks after baseline)
Title
Change from baseline at 8-weeks on the Perceived Stress Scale (10 items)
Description
This produces a score between 0 and 40, with higher scores indicating higher levels of perceived stress.
Time Frame
Follow-up (8-weeks after baseline)
Other Pre-specified Outcome Measures:
Title
Change from baseline at 4-weeks on the Food Allergy Self-Efficacy Scale for Parents
Description
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.
Time Frame
Post-intervention (4-weeks after baseline)
Title
Change from baseline at 8-weeks on the Food Allergy Self-Efficacy Scale for Parents
Description
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.
Time Frame
Follow-up (8-weeks after baseline)
Title
Change from baseline at 4-weeks on the Intolerance of Uncertainty Scale
Description
This measures participants' ability to tolerate uncertainty, producing scores between 27 and 135, with higher scores indicating lower tolerance of uncertainty.
Time Frame
Post-intervention (4-weeks after baseline)
Title
Change from baseline at 8-weeks on the Intolerance of Uncertainty Scale
Description
This measures participants' ability to tolerate uncertainty, producing scores between 27 and 135, with higher scores indicating lower tolerance of uncertainty.
Time Frame
Follow-up (8-weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Sugunasingha, BSc, PGCert
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fergal Jones, PhD, PsychD
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christina Jones, PhD
Organizational Affiliation
Brighton & Sussex Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Salomons Centre for Applied Psychology, Canterbury Christ Church University
City
Tunbridge Wells
State/Province
Kent
ZIP/Postal Code
TN1 2YG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
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