Group CBT Intervention for Parents of Children With Food Allergy
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04774796 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of Surrey |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Gina Sherlock |
Principal Investigator Affiliation | University of Surrey |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Active, not recruiting |
Countries | United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Allergy;Food, Parents, Psychological Distress |
Study Website: | View Trial Website |
Contact a Trial Team
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