The Quality of Life of Parents of Children With Food Allergy Clinical Trial
Official title:
Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.
| Verified date | March 2022 |
| Source | Canterbury Christ Church University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | February 2, 2022 |
| Est. primary completion date | December 8, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Salomons Institute for Applied Psychology | Tunbridge Wells | Kent |
| Lead Sponsor | Collaborator |
|---|---|
| Canterbury Christ Church University | University of Surrey |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) | 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. | Post intervention (week 15) | |
| Secondary | Change from baseline at week 23 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) | 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. | Follow up (week 23) | |
| Secondary | Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7) | This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity. | Post intervention (week 15) | |
| Secondary | Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7) | This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity. | Follow up (week 23) | |
| Secondary | Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8) | This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity. | Post intervention (week 15) | |
| Secondary | Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8) | This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity. | Follow up (week 23) | |
| Secondary | Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS) | This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress. | Post intervention (week 15) | |
| Secondary | Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS) | This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress. | Follow up (week 23) | |
| Secondary | Change from baseline at week 15 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15) | This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness. | Post intervention (week 15) | |
| Secondary | Change from baseline at week 23 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15) | This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness. | Follow up (week 23) | |
| Secondary | Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items | This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity. | Post intervention (week 15) | |
| Secondary | Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items | This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity. | Post intervention (week 23) | |
| Secondary | Change from baseline at week 15 on the Leiden Index of Depression Sensitivity-Revised - 34 items | This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity. | Post intervention (week 15) | |
| Secondary | Change from baseline at week 23 on the Leiden Index of Depression Sensitivity-Revised - 34 items | This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity. | Post intervention (week 23) |