CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Cognitive Behavioural Therapyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04774796
NCT04774796N/ACompleted

The Feasibility of a Group CBT Intervention for Improving Psychological Outcomes in Parents of Children With Food Allergy

University of Surrey·interventional·Posted Mar 1, 2021·Updated Jul 6, 2022

In Brief

A clinical study evaluating Cognitive Behavioural Therapy for Allergy;Food and 2 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 1, 2021
Enrollment StartFeb 1, 2021
Primary CompletionNov 25, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.3 years ago

Interventions

Cognitive Behavioural Therapyother

Participants will take part in a one day, or two half-day group CBT workshop for parents of children with food allergy. The workshop will included understanding difficulties using a CBT model, psychoeducation on common psychological issues (e.g. anxiety) and the development of skills to help deal with maladaptive cognitions and behaviours relating to managing a child's food allergy.