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

Primary Purpose

The Quality of Life of Parents of Children With Food Allergy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness-based cognitive therapy
Treatment as usual
Sponsored by
Canterbury Christ Church University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Quality of Life of Parents of Children With Food Allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Salomons Institute for Applied Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MBCT-PCCFA plus TAU

TAU control

Arm Description

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.

Treatment as usual control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 1, 2021
Last Updated
March 29, 2022
Sponsor
Canterbury Christ Church University
Collaborators
University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT04738890
Brief Title
Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies
Official Title
Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canterbury Christ Church University
Collaborators
University of Surrey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Quality of Life of Parents of Children With Food Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT-PCCFA plus TAU
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU control
Arm Type
Other
Arm Description
Treatment as usual control group
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based cognitive therapy
Intervention Description
Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.
Primary Outcome Measure Information:
Title
Change from baseline at week 15 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)
Description
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.
Time Frame
Post intervention (week 15)
Secondary Outcome Measure Information:
Title
Change from baseline at week 23 on the Food Allergy Quality of Life-Parental Burden scale - 17 item version (FAQL-PB)
Description
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.
Time Frame
Follow up (week 23)
Title
Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)
Description
This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity.
Time Frame
Post intervention (week 15)
Title
Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)
Description
This measures symptoms of anxiety producing a score between 0 and 21, with higher scores indicating greater symptom severity.
Time Frame
Follow up (week 23)
Title
Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8)
Description
This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity.
Time Frame
Post intervention (week 15)
Title
Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8)
Description
This measures symptoms of depression producing a score between 0 and 24, with higher scores indicating greater symptom severity.
Time Frame
Follow up (week 23)
Title
Change from baseline at week 15 on the Perceived Stress Scale - 10 items (PSS)
Description
This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress.
Time Frame
Post intervention (week 15)
Title
Change from baseline at week 23 on the Perceived Stress Scale - 10 items (PSS)
Description
This measures the perception of stress producing a score between 0 and 40, with higher scores indicating greater perceived stress.
Time Frame
Follow up (week 23)
Title
Change from baseline at week 15 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15)
Description
This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness.
Time Frame
Post intervention (week 15)
Title
Change from baseline at week 23 on the Five-Facet Mindfulness Questionnaire - 15 items (FFMQ-15)
Description
This measures trait mindfulness producing a score from 15 to 75, with higher score indicating greater trait mindfulness.
Time Frame
Follow up (week 23)
Title
Change from baseline at week 15 on the Perth Emotional Reactivity Scale Short Form - 18 items
Description
This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity.
Time Frame
Post intervention (week 15)
Title
Change from baseline at week 23 on the Perth Emotional Reactivity Scale Short Form - 18 items
Description
This measures emotional reactivity producing a score between 30 and 90, with higher scores indicating greater emotional reactivity.
Time Frame
Post intervention (week 23)
Title
Change from baseline at week 15 on the Leiden Index of Depression Sensitivity-Revised - 34 items
Description
This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity.
Time Frame
Post intervention (week 15)
Title
Change from baseline at week 23 on the Leiden Index of Depression Sensitivity-Revised - 34 items
Description
This measures cognitive reactivity producing a score between 0 and 136, with higher scores indicating greater cognitive reactivity.
Time Frame
Post intervention (week 23)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellie Craig, MSc
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fergal Jones, PhD, PsychD
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christina Jones, PhD
Organizational Affiliation
University of Surrey
Official's Role
Study Director
Facility Information:
Facility Name
Salomons Institute for Applied Psychology
City
Tunbridge Wells
State/Province
Kent
ZIP/Postal Code
TN1 2YG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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