Group CBT in Parents of Children With Food Allergy
ConditionParents
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-17
SponsorUniversity of Missouri, Kansas City
About this trial
Parents of children with food allergies that are medically established will be able to participate in 6 one-hour weekly virtual Cognitive Behavioral Therapy (CBT) groups, and outcomes will be measured for anxiety, depression and quality of life. Possible benefits include improvement in psychological functioning and quality of life of families, as well as improved understanding of the use of group Cognitive Behavioral Therapy (CBT) for parents of children with medically established food allergies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Parent, age >18yrs
All genders
Child must be aged 18 months - 17yrs with serious food allergy(ies), medically diagnosed
Meets cut-offs for anxiety and/or depression on the Hospital Anxiety and Depression Scale (need to define)
Disqualifiers
Parental history of recent suicidal ideation / suicide attempt
Current Suicidal ideation
Current substance abuse
Parent currently in psychiatric treatment and medications being adjusted
Trial design
Design model
Single group
Treatments tested in this trial
CBT
BehavioralVirtual CBT groups
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Virtual Cognitive Behavioral Therapy (CBT) groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Score of Food Allergy Quality of Life-Parent Burden Questionnaire (FAQL-PB)
17-item instrument, using a 7-point Likert scale ranging from 1 (not troubled) to 7 (extremely troubled) anxieties over the past week.
Time frame
14 weeksSecondary outcomes
1
Subject Satisfaction Questionnaire
An 11-question scale, each item scored 1 (not satisfied at all) to 5 (very satisfied). Scores range from 5 to 55, with a higher score indicating higher subject satisfaction
Time frame
14 weeks2
Change in Score of Pediatric Food Allergy Quality of Life Scale
A 25-question scale, each item scored 1 (never) to 4 (always). Scores range from 25 to 100, with a higher score indicating poorer quality of life
Time frame
14 weeks3
Change in Score of Hospital Anxiety and Depression Scale (HADS)
A 14 item-scale, of which 7 items measure anxiety and 7 measure depression, each item is scored from 0 to 3
Time frame
14 weeksSponsors and contacts
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Source ClinicalTrials.gov