Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies

December 12, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Mindfulness-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
Other: Treatment as usual
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
Other: Treatment as usual
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 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)
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 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.
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 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.
Post intervention (week 23)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canterbury Christ Church University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Surrey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ellie Craig, MSc, Canterbury Christ Church University
  • Study Director: Christina Jones, PhD, University of Surrey
  • Study Director: Fergal Jones, PhD, PsychD, Canterbury Christ Church University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on The Quality of Life of Parents of Children With Food Allergy

Clinical Trials on Mindfulness-based cognitive therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings