Food Allergy in Children Clinical Trial
Official title:
Feasibility of a Group Intervention Using Cognitive Behavioural Therapy (CBT) to Reduce Anxiety for Children Aged 12-17 With Food Allergy.
Verified date | August 2022 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The research will design and evaluate a CBT based intervention to support children aged 11-17 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.
Status | Completed |
Enrollment | 52 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility | Inclusion Criteria: - Children and Adolescents ages 11-17 years with a food allergy. - To have reported anxiety or worry in relation to management of food allergy. - Able to attend the one-day workshop at the University of Surrey to complete the intervention in full (or online alternative). - Willing and able to comprehend English and provide assent/consent. Exclusion Criteria: - Child does not speak English. - Able and willing to engage and understand the content of the workshop. - Currently under a mental health team and receiving ongoing psychological input. - Do not have the capacity to provide informed assent/consent and/or consent not gained from caregivers. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Surrey | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
University of Surrey |
United Kingdom,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographics | Food allergy and anxiety characteristics | Baseline | |
Other | Feasibility of the intervention in terms of the number interested, recruited and completion of the intervention. | Number of children invited to the study, number of children interested in participating in the study, number of children meeting eligibility criteria, number of children recruited and participating in the intervention, number of children that completed the intervention. | 3 months post workshop | |
Primary | Change in Food Allergy Quality of Life Questionnaire (FAQLQ-CF) - Child Form (8-12 years) or Teenager Form (13-17 years) | Child reported quality of life measure specific to food allergy. The FAQLQ-CF provides a self-report on the child's Health Related Quality of Life and contains 24 items and four domains (Risk of Accidental Exposure, Emotional Impact, Allergen Avoidance and Dietary Restrictions) Items were scored on a seven-point scale ranging from not troubled to extremely troubled. For the child form, in order to improve understanding, the scale was illustrated by drawings of faces ('smileys'), ranging from a smiling face to a sad face. The total FAQLQ score is the sum of all the items divided by the number of items and ranges from 1 (minimal impairment) to 7 (maximal impairment). | Baseline, 1 month & 3 month post follow ups | |
Primary | Change in Penn State Worry Questionnaire for Children (PSWQ-C) | Child reported worry measure. Respondents are asked to rate how often each item applies to them by choosing from a 4-point Likert scale consisting of never (0), sometimes (1), often (2) and always (3). The scores from each item are summed together to yield a total score that ranges from 0-42, with higher scores reflecting higher levels of worry. | Baseline, 1 month & 3 month post follow ups | |
Secondary | Change in Coping Strategies Inventory (CSI) | Assesses coping thoughts and behaviours in response to a specific stressor (food allergy). After describing a stressful situation, persons taking the CSI are asked to respond to 32 questions in a 5-item Likert format. Respondents indicate for each item the extent to which they performed that particular coping response in dealing with the previously described situation (not at all, a little, somewhat, much, very much). Current scoring practices for the CSI involve giving all items in a particular subscale equalweights. To obtain the raw score for a subscale, simply add the item scores. With the higher score suggesting more use of that strategy. | Baseline, 1 month & 3 month post follow ups | |
Secondary | Change in Adherence to food allergy specific self-care behaviours | Assessment of adherence to food allergy specific self-care behaviours. Questionnaire. Five items. Responses are measured on a 6-point scale (0-5) how much each statement applies to them. Higher the score suggests poorer self-care behaviours. | Baseline, 1 month & 3 month post follow ups | |
Secondary | Change in Food Allergy Quality of Life Questionnaire (FAQLQ-PF)- Parent Form (8-12 years) or Parent Form (13-17 years) | Parent reported survey of child quality of life. The FAQLQ-PF provides a parent report on the child's Health related quality of life and contains 30 items for children aged 0-12 (child form) and 13-17 (teenager form) years. Items are divided into three domains (Emotional Impact, Food Anxiety and Social & Dietary Limitations) and scored in the same way as the FAQLQ-CF. | Baseline, 1 month & 3 month post follow ups | |
Secondary | Intervention Feedback Survey | Satisfaction and experience with intervention, Client Change Interview Schedule | 3 month post workshop | |
Secondary | Change in Goals based outcome measure | Goals from workshop and success at achieving on a scale from 0 (Goal not at all met) to 10 (Goal achieved). The higher the score, the better the outcome. | Baseline, 1 month & 3 month post follow ups |
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