Psychological Distress Clinical Trial
Official title:
The Feasibility of a Group CBT Intervention for Improving Psychological Outcomes in Parents of Children With Food Allergy
Verified date | August 2021 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | November 25, 2021 |
Est. primary completion date | November 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
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 | Demographic Questionnaire (researcher developed) | A questionnaire to gather demographic information from the parent and food allergy information about their child. | Baseline | |
Primary | Change in Food Allergy Quality of Life - Parental Burden Scale (Cohen et al., 2004) | 17-item self-report scale which utilises a 7-point Likert scale in order to assess the burden of food allergy felt on the family. Higher scores represent greater parental burden. | Baseline, and 1 & 3 month follow ups | |
Primary | Change in Depression, Anxiety and Stress Scales; short form version (Lovibond & Lovibond, 1995) | 21-item self-report scale that is made up of three individual seven-item scales that measure depression, anxiety and stress. Higher scores represent higher levels of depression, anxiety and stress. | Baseline, and 1 & 3 month follow ups | |
Primary | Change in Penn State Worry Questionnaire (Meyer et al., 1990) | 16-item self-report scale to measure worry. Higher scores indicate greater worry. | Baseline, and 1 & 3 month follow ups | |
Primary | Feedback questionnaire (researcher developed) | Participants in the intervention group will be asked to complete a feedback questionnaire, in order for researchers to evaluate the CBT intervention and assess acceptability and feasibility. | 3 month follow up | |
Secondary | Change in Food Allergy Self-Efficacy Scale for Parents (Knibb, 2015) | 21-item self-report scale with five subscales (managing social activities, precaution and prevention, allergic treatment, food allergen identification, and seeking information about food allergy). It is scored on a scale of 0-100, with higher scores indicate greater self-efficacy for food allergy management. | Baseline, and 1 & 3 month follow ups | |
Secondary | Change in Goal-Based Outcomes (researcher developed) | A goal-based outcome measure will be used to evaluate progress towards participant goals which will be collaboratively developed as part of the CBT intervention. This measure will be used for those in the intervention group only. Participants will be asked to rate the progress they feel they have made towards their goal from 0 to 10 (0 = no progress, 5 = exactly half-way to meeting the goal & 10 = met goal fully) | 1 & 3 month follow ups |
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