Clinical trial NCT04774796: Group CBT Intervention for Parents of Children With Food Allergy
Official title: The Feasibility of a Group CBT Intervention for Improving Psychological Outcomes in Parents of Children With Food Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy;Food
Parents
Psychological Distress
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Food allergy has been found to have a profound impact on parents of children with food allergy, with caregivers experiencing poorer psychological outcomes such as increased stress, anxiety, worry and depression than parents of non-allergic children. Furthermore, they report poorer quality of life (QoL) due to the psychosocial impact of looking after a child with food allergy, identifying the need for parental interventions aimed at improving these outcomes. There has generally been a paucity of research in this area, but there has recently been encouraging evidence to suggest that interventions involving Cognitive Behavioural Therapy (CBT) have the potential to improve the lives of those parents impacted by a child's food allergy. This study aims to add to this emerging evidence base by reporting on the feasibility of a brief, group CBT intervention for parents of children with food allergy. This small, proof of concept study also aims to report on a range of psychological measures to see if there is any evidence that this intervention may be effective in improving outcomes. Thirty to forty parents of children with food allergy will be recruited to the study and randomised to receive either a one-day or two half-day group CBT intervention or treatment as usual. Measures of a range of psychological outcomes, food allergy specific QoL and goal-based outcomes will be taken at baseline and at one and three-month follow ups. Participants will be asked for their feedback so that researchers can report on the acceptability of the intervention for those involved. This study is also interested in hearing about the parental experience of accessing psychological therapies as it is still not clear why some parents may require psychological intervention whilst others may not; participants in the intervention group will be invited to take part in interviews in order to share their experiences. It is hoped that this set of findings will help to determine if a brief group CBT intervention could be recommended for efficacy testing as part of a wider effort to provide evidence-based treatments for parents of children with food allergy experiencing poor psychological outcomes and poor food allergic-specific QoL.

Detailed description: Food allergy is the adverse reaction of the body's immune system to the ingestion of food protein. When a food allergen is ingested, the immune system detects the food protein as a threat and releases a number of chemicals which cause the symptoms of an allergic reaction. These symptoms can include watery eyes, a running nose, itching, rashes, swelling and gastrointestinal problems, and may vary in their severity. Reactions can progress to anaphylaxis, which is a serious allergic reaction that is rapid in onset; symptoms can include a range of frightening respiratory, gastrointestinal and cardiovascular symptoms which may result in death if not treated promptly and effectively with adrenaline.

In the UK, food allergy is a prevalent problem, with an estimated 2 million people living with a diagnosed food allergy in the UK. Prevalence rates are higher in children than in adults, with an estimated 6-7% of children affected compared to 1-2% of adults, with this prevalence thought to be increasing. Currently, treatment involves avoidance of food allergens and the administration of treatment for accidently ingested foods.

The current management of food allergy involves the burden of constant vigilance, planning and preparation, with this responsibility often falling on parents (particularly the mothers) of young children. Furthermore, those with food allergy and their caregivers have to manage the unpredictable nature of food allergy and live continually with the risk and fear of accidental food ingestion which can negatively impact the Quality of Life (QoL) of allergy sufferers and their immediate family.

Research in this field has started to examine the psychological impact food allergy can not only have on the allergic child but also their parents. Previous studies have suggested that allergic children and their mothers experience higher stress and anxiety levels compared to the general population. Reasons why food allergy can cause such distress in parents include: the constant vigilance needed to check safety of foods; anxiety caused by severe and potentially fatal consequences of accidental ingestion of the food allergen; anxiety caused by handing over control of allergy management to the child (for example reading their own food labels); risk from the environment including people not understanding the impact of food allergy; worry about the future of their child, and dietary restrictions leading to social restrictions and potentially isolation. Given the impact looking after a child with food allergy can have on mental health and QoL in parents, the need for interventions to improve psychological outcomes is of high importance.

To date, there has been a paucity of research on interventions to improve psychological outcomes for parents of children with a food allergy. However, there is emerging evidence to suggest that Cognitive Behavioural Therapy (CBT) may be a promising intervention for parents experiencing poor psychological outcomes and QoL. CBT is a short-term therapy based on the rationale that what individuals think and do affects the way individuals feel. It has a strong evidence base for a range of mental health issues including anxiety and depression, and therefore may be appropriate for parents experiencing high levels of stress, anxiety and depression in relation to a child's food allergy. In the first study which reported on the effectiveness of CBT for mothers of children with a food allergy, five mothers received 12 weeks of individual face-to-face CBT, with six mothers acting as controls. All participants completed measures of anxiety, depression, worry, stress, general mental health, generic and food allergy specific QoL at baseline and at 12 weeks. Results showed that anxiety, depression and worry in the CBT group significantly reduced and overall mental health and QoL significantly improved from baseline to 12 weeks for mothers in the CBT group. A larger randomised control trial supported these promising initial findings. Two hundred mothers of children with food allergy were randomised to receive either a single-session CBT intervention or standard care, with anxiety and risk perception assessed at 6 weeks and 1 year. Results found significantly reduced state anxiety at six weeks in the intervention group, in the subgroup of mothers with moderate to high anxiety at enrolment and reduced risk perception. The study also found evidence of a reduction in physiological stress response in the intervention group, as measured by a salivary cortisol response to a simulated anaphylaxis scenario at one year. The results of both of these studies indicate that a CBT intervention may be an appropriate intervention for parents of children with food allergy.

This study seeks to add to this emerging evidence base by reporting on the feasibility of a brief group CBT intervention for improving psychological outcomes and food allergy specific QoL in parents of children with food allergy. There is already evidence that non-CBT-specific group interventions for parents with food allergic children can both be acceptable to parents and decrease parental burden, however, this study is the first to the researchers' knowledge to report on the feasibility of a brief group CBT intervention for parents of children with food allergy. Although a brief (one-day) intervention may seem optimistic in being able to bring about change, previous research in the field of child anxiety has shown promising evidence for the use of one-day interventions. A recent study has shown that children whose parents attended a one-day group intervention were 16.5% less likely to have an anxiety disorder than children whose parents received treatment as usual, highlighting than an inexpensive, one-day psycho-educational intervention may be useful in bringing about change. Group CBT interventions have the potential to offer a non-time consuming and cost-effective treatment option for parents of children with food allergy, an important factor for high in demand allergy services.

Qualitative research has provided insights into why food allergy can cause distress, however, reasons why parents access psychological support and their experiences of this, is still relatively unexplored. Differences in parental coping styles and levels of distress have been noted, indicating that only a sub-set of parents of food-allergic children may require psychological intervention. This study aims to speak to parents about their experiences of accessing psychological support (e.g. reasons for accessing psychological support, how other forms of support have helped/hindered and how they think a psychological intervention may help) in order to shed light on who CBT interventions may be most helpful for, and what CBT should comprise of for this group.

This study therefore is a contribution to the wider effort of providing evidence-based treatments for parents of children with food allergy impacted by the distressing psychosocial implications of caring for a food allergic child.

Eligibility criteria: Inclusion Criteria:

* Individuals must be the parent of at least one child with a diagnosed food allergy aged 0-17 years, currently experiencing difficulties with their wellbeing, in relation to their child's food allergy.

Exclusion Criteria:

* Individuals under the current care of a mental health care team or receiving any form of psychological intervention/treatment.
* Individuals taking part in another research study involving psychological intervention
* Individuals who do not have the capacity to provide informed consent
* Individuals who are not able to understand written and spoken English
* Individuals not able to access workshop materials (e.g. do not have an internet connection to take part in online workshops).

Primary outcomes:
measure: Change in Food Allergy Quality of Life - Parental Burden Scale (Cohen et al., 2004)
timeFrame: Baseline, and 1 & 3 month follow ups
measure: Change in Depression, Anxiety and Stress Scales; short form version (Lovibond & Lovibond, 1995)
timeFrame: Baseline, and 1 & 3 month follow ups
measure: Change in Penn State Worry Questionnaire (Meyer et al., 1990)
timeFrame: Baseline, and 1 & 3 month follow ups
measure: Feedback questionnaire (researcher developed)
timeFrame: 3 month follow up
Secondary outcomes:
measure: Change in Food Allergy Self-Efficacy Scale for Parents (Knibb, 2015)
timeFrame: Baseline, and 1 & 3 month follow ups
measure: Change in Goal-Based Outcomes (researcher developed)
timeFrame: 1 & 3 month follow ups
Other outcomes:
measure: Demographic Questionnaire (researcher developed)
timeFrame: Baseline
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
state: Surrey
Study officials:
affiliation: University of Surrey
name: Gina Sherlock
role: PRINCIPAL_INVESTIGATOR
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