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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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The Well Being of Parents of Children With Food Allergies

Intervention / Treatment
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* Other: Online self-help


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |