The Well Being of Parents of Children With Food Allergies
Conditions
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).
Interventions
OTHEROnline self-help
As detailed in experimental arm description.
Sponsors
Brighton & Sussex Medical School
Canterbury Christ Church University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline at 4-weeks on the Intolerance of Uncertainty Scale | Post-intervention (4-weeks after baseline) | This measures participants' ability to tolerate uncertainty, producing scores between 27 and 135, with higher scores indicating lower tolerance of uncertainty. |
| Change from baseline at 8-weeks on the Intolerance of Uncertainty Scale | Follow-up (8-weeks after baseline) | This measures participants' ability to tolerate uncertainty, producing scores between 27 and 135, with higher scores indicating lower tolerance of uncertainty. |
| Change from baseline at 4-weeks on the Food Allergy Self-Efficacy Scale for Parents | Post-intervention (4-weeks after baseline) | 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. |
| Change from baseline at 8-weeks on the Food Allergy Self-Efficacy Scale for Parents | Follow-up (8-weeks after baseline) | 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. |
Countries
United Kingdom
Outcome results
None listed