CBT Group Intervention for Children With Food Allergy and Anxiety
Study Purpose
The research will design and evaluate a CBT based intervention to support children aged 12-17 with food allergies. The research on this population has shown that they can experience high levels of anxiety in management of their allergy which can have a significant impact on quality of life. However, the research exploring psychological interventions is limited. CBT has a wide evidence base from NHS settings delivering interventions to support those with various health conditions. In addition, CBT has been shown to be effective for supporting adolescents manage their health-related anxiety. The investigators are interested in the feasibility of designing and implementing a one day workshop aimed at adolescents with food allergy and self-reported anxiety. The group workshop will involve psychoeducation on anxiety, skills and techniques to manage anxiety, relaxation and how to set goals in relation to their food allergy. It will involve 2 'arms', one where participants will attend the group and the other 'control arm' where they will not attend the group but they will receive materials from the group once the evaluation is complete. All participants will be asked to complete questionnaires that measure level of anxiety, food allergy quality of life and coping skills at baseline, time of workshop, one month follow up and three month follow up. There will also be an opportunity for participants to volunteer to take part in a follow up interview to evaluate the workshop and also to contribute more to the research on what this population requires in terms of a psychological intervention.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
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 | 12 Years - 17 Years |
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. |
NCT04770727 |
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. |
Holly Tallentire, BSc |
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. |
Food Allergy in Children |
Contact a Trial Team
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