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

NCT04738890 | Completed

• 1 other identifier: EllieCraig2021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

The Quality of Life of Parents of Children With Food Allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Follow up (week 23)

• Change from baseline at week 15 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)

  Post intervention (week 15)

• Change from baseline at week 23 on the Generalized Anxiety Disorder screener - 7 items (GAD-7)

  Follow up (week 23)

• Change from baseline at week 15 on the Patient Health Questionnaire - 8 items (PHQ-8)

  Post intervention (week 15)

• Change from baseline at week 23 on the Patient Health Questionnaire - 8 items (PHQ-8)

  Follow up (week 23)

Study Arms (2)

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.

Behavioral: Mindfulness-based cognitive therapy; Other: Treatment as usual

TAU control

OTHER

Treatment as usual control group

Other: Treatment as usual

Interventions

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

MBCT-PCCFA plus TAU

Treatment as usual OTHER

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

MBCT-PCCFA plus TAU; TAU control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canterbury Christ Church University: lead
• University of Surrey: collaborator

Study Sites (1)

Salomons Institute for Applied Psychology

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

Location

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ellie Craig, MSc

  Canterbury Christ Church University

  PRINCIPAL INVESTIGATOR

• Fergal Jones, PhD, PsychD

  Canterbury Christ Church University

  STUDY DIRECTOR

• Christina Jones, PhD

  University of Surrey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: March 2, 2021
• Primary Completion: December 8, 2021
• Study Completion: February 2, 2022
• Last Updated: December 17, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)