- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04738890
Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies
March 29, 2022 updated by: Canterbury Christ Church University
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).
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kent
-
Tunbridge Wells, Kent, United Kingdom, TN1 2YG
- Salomons Institute for Applied Psychology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBCT-PCCFA plus TAU
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.
|
Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing
Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.
|
Other: TAU control
Treatment as usual control group
|
Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Post intervention (week 15)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
|
Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)
Time Frame: Post intervention (week 15)
|
This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity.
|
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)
|
This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity.
|
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)
|
This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity.
|
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)
|
This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity.
|
Follow up (week 23)
|
Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS)
Time Frame: Post intervention (week 15)
|
This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress.
|
Post intervention (week 15)
|
Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS)
Time Frame: Follow up (week 23)
|
This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress.
|
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)
|
This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness.
|
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)
|
This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness.
|
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)
|
This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity.
|
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)
|
This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity.
|
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)
|
This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity.
|
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)
|
This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity.
|
Post intervention (week 23)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ellie Craig, MSc, Canterbury Christ Church University
- Study Director: Christina Jones, PhD, University of Surrey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2021
Primary Completion (Actual)
December 8, 2021
Study Completion (Actual)
February 2, 2022
Study Registration Dates
First Submitted
February 1, 2021
First Submitted That Met QC Criteria
February 1, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EllieCraig2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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