The Quality of Life of Parents of Children With Food Allergy
Conditions
Brief summary
This study aims to conduct an initial evaluation of adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA).
Detailed description
This study is a pilot randomised controlled trial (RCT) comparing adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA) with a treatment as usual control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 15) and at follow-up (week 23).
Interventions
BEHAVIORALMindfulness-based cognitive therapy
Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing
OTHERTreatment as usual
Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.
Sponsors
University of Surrey
Canterbury Christ Church University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Parents or caregivers who identify as having a child under the age of 18 with a food allergy * The allergy has been diagnosed by a qualified physician (e.g. GP or allergy specialist) * Mean score of \>=2 on the FAQL-PB, indicating they are at least 'somewhat limited/troubled' by their child's allergy (Cohen et al., 2004). * Resident in the United Kingdom * Have access to email, a PC/laptop/tablet with a webcam and microphone and internet access to allow videoconferencing
Exclusion criteria
* They had consulted on the design and content of the intervention or study * They have already participated in a substantial mindfulness-based course * They are currently engaged or are planning to engage with another psychological intervention during the course of the study * They currently engage in regular mindfulness-based practice * They do not have the practical means and time available to be able to attend the intervention during the dates outlined on the information sheet and commit to at-home practice * They have scores \>19 on PHQ-8 (indicating 'severe' depressive symptom severity; Kroenke et al., 2009) or \>15 on GAD (indicating 'severe' level of anxiety; Spitzer et al., 2006) * They have a problem with alcohol or recreational drug misuse * They have experienced thoughts about harming themselves or others in the last 12 months * They have been given a diagnosis of psychosis * They are currently experiencing high levels of distress and/or currently feeling particularly fragile * They have experienced a bereavement of someone close to them in the last year or are continuing to experience continuing grief in relation to losing someone further back in time * They have had traumatic experiences that they continue to be troubled by (including, but not limited to, receiving diagnosis of post-traumatic stress disorder) * They experience significant difficulty being in a group with other people. NB: for further details re the FAQL-PB and PHQ-8, please see the outcome measures section.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) | Post intervention (week 15) | This measures quality of life in parents of children with food allergies producing a score between 17 and 119, with higher scores indicating a greater burden on the family. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7) | Post intervention (week 15) | This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity. |
| Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7) | Follow up (week 23) | This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity. |
| Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8) | Post intervention (week 15) | This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity. |
| Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8) | Follow up (week 23) | This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity. |
| Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS) | Post intervention (week 15) | This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress. |
| Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS) | Follow up (week 23) | This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress. |
| Change from baseline at week 23 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) | Follow up (week 23) | This measures quality of life in parents of children with food allergies producing a score between 17 and 119, with higher scores indicating a greater burden on the family. |
| Change from baseline at week 23 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15) | Follow up (week 23) | This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness. |
| Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items | Post intervention (week 15) | This measures emotional reactivity producing separate composite scores for positive and negative emotion (i.e. 'general positive reactivity' and 'general negative reactivity'), each of which varies between 9 and 45, with higher scores indicating greater emotional reactivity. Note: this corrects a previous error where it was mistakenly stated that this scale produces a single overall score. |
| Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items | Post intervention (week 23) | This measures emotional reactivity producing separate composite scores for positive and negative emotion (i.e. 'general positive reactivity' and 'general negative reactivity'), each of which varies between 9 and 45, with higher scores indicating greater emotional reactivity. Note: this corrects a previous error where it was mistakenly stated that this scale produces a single overall score. |
| Change from baseline at week 15 on the Leiden Index of Depression Sensitivity-Revised - 34 items | Post intervention (week 15) | This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity. |
| Change from baseline at week 23 on the Leiden Index of Depression Sensitivity-Revised - 34 items | Post intervention (week 23) | This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity. |
| Change from baseline at week 15 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15) | Post intervention (week 15) | This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness. |
Countries
United Kingdom
Outcome results
None listed