The Quality of Life of Parents of Children With Food AllergyNCT04738890
Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies
A study testing Mindfulness-based cognitive therapy and Treatment as usual in people with The Quality of Life of Parents of Children With Food Allergy, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Quality of Life of Parents of Children With Food Allergy
- What is being tested?
- Mindfulness-based cognitive therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2021to 2 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salomons Institute for Applied Psychology
Royal Tunbridge Wells, Kent, TN1 2YG
About this study
Official title: Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.
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).
Read the 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).
- Being tested
- Mindfulness-based cognitive therapy, Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based cognitive therapyBehavioural
Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing
Treatment as usualOther
Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-PCCFA plus TAU | Experimental | Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing, plus treatment as usual. Receives: Behavioral: Mindfulness-based cognitive therapy; Other: Treatment as usual |
| TAU control | Other | Treatment as usual control group Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post intervention (week 15)
Secondary outcomes (13)
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.
Measured: Follow up (week 23)
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.
Measured: Post intervention (week 15)
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.
Measured: Follow up (week 23)
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.
Measured: Post intervention (week 15)
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.
Measured: Follow up (week 23)
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.
Measured: Post intervention (week 15)
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.
Measured: Follow up (week 23)
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.
Measured: Post intervention (week 15)
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.
Measured: Follow up (week 23)
Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items
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.
Measured: Post intervention (week 15)
Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items
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.
Measured: Post intervention (week 23)
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.
Measured: Post intervention (week 15)
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.
Measured: Post intervention (week 23)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start2 Mar 2021
- Primary completion8 Dec 2021
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Quality of Life of Parents of Children With Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey
- Responsible party
- Sponsor
- Investigators
- Ellie Craig, MSc, Principal investigator, Canterbury Christ Church UniversityFergal Jones, PhD, PsychD, Study director, Canterbury Christ Church UniversityChristina Jones, PhD, Study director, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738890
- Sponsor's protocol ID
- EllieCraig2021
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 2021
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available to other researchers on email request to the corresponding author after the study findings have been published in a peer reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT04738890
- Acronym / sponsor ID
- EllieCraig2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Collaborators
- University of Surrey
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT-PCCFA plus TAU | Experimental | Behavioral: Mindfulness-based cognitive therapy, Other: Treatment as usualMindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing, plus treatment as usual. |
| TAU control | Other | Other: Treatment as usualTreatment as usual control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based cognitive therapyMindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing | Behavioural | MBCT-PCCFA plus TAU |
| Treatment as usualContinuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment. | Other | MBCT-PCCFA plus TAU, TAU control |
Primary outcome
Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)
Time frame: 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.
13 secondary outcomes
Change from baseline at week 23 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)
Time frame: Follow up (week 23)
Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)
Time frame: Post intervention (week 15)
Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)
Time frame: Follow up (week 23)
Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8)
Time frame: Post intervention (week 15)
Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8)
Time frame: Follow up (week 23)
Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS)
Time frame: Post intervention (week 15)
Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS)
Time frame: Follow up (week 23)
Change from baseline at week 15 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15)
Time frame: Post intervention (week 15)
Change from baseline at week 23 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15)
Time frame: Follow up (week 23)
Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items
Time frame: Post intervention (week 15)
Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items
Time frame: Post intervention (week 23)
Change from baseline at week 15 on the Leiden Index of Depression Sensitivity-Revised - 34 items
Time frame: Post intervention (week 15)
Change from baseline at week 23 on the Leiden Index of Depression Sensitivity-Revised - 34 items
Time frame: Post intervention (week 23)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Yes. IPD will be available to other researchers on email request to the corresponding author after the study findings have been published in a peer reviewed journal.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellie Craig, MSc principal investigator
Canterbury Christ Church University
Fergal Jones, PhD, PsychD study director
Canterbury Christ Church University
Christina Jones, PhD study director
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based cognitive therapy and Treatment as usual in people with The Quality of Life of Parents of Children With Food Allergy, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB) (time frame: Post intervention (week 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.