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Completed

NCT Number: NCT04738890

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

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).

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Key information

Conditions

The Quality of Life of Parents of Children With Food Allergy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salomons Institute for Applied Psychology

Royal Tunbridge Wells, Kent, TN1 2YG, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Cognitive Therapy

Behavioral

Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing

Treatment as Usual

Other

Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Collaborators

  • University of Surrey

Registry information

Official study title

Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies: A Pilot Randomised Control Trial.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 4, 2021
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.