This will be a non-blinded, prospective cohort study. Scores related to quality of life,
depression, and anxiety will be measured at baseline, upon completion of the respective
interventions, and 2 months after completion in parents of food allergic children.
Instruments used will include the Patient Health Questionnaire-9 (PHQ-9) (baseline
screening), Generalized Anxiety Disorder-7 (GAD-7) (baseline screening), Food Allergy
Quality of Life - Parental Burden Scale (FAQL-PB) the Pediatric Food Allergy Quality of
Life Questionnaire (PFA-QL) parent form, the Food Allergy Self-Efficacy Scale for Parents
(FASE-P) and the Hospital Anxiety and Depression Scale (HADS). Scores on these
questionnaires will be collected at the beginning of the study, at the last session of
the intervention, and 2 months after the end of the intervention.
For additional baseline and demographic characteristics, the investigators will also
collect child's age, sex, parental educational level, food allergy factors, and comorbid
physical and psychiatric conditions. Also, at baseline, the investigators will screen for
bullying given its prevalence among the food allergic population. The investigators
referred to existing literature on bullying in children with food allergies for a general
question, "Has the food-allergic individual ever been bullied, teased, or harassed
because of food allergy?" To target the parent who will be answering this question, the
investigators will change "food-allergic individual" to "your child." The group Cognitive
Behavioral Therapy (CBT) sessions will occur on a weekly basis at over Zoom meetings.
Each session will last 1 hour. There will be a total of 6 sessions of intervention, and
an additional session 2 months after the 6th session for parents to complete the
follow-up questionnaire (no intervention during the 7th session).
A research staff member will take attendance and coordinate group logistics of the
groups, as well as check fidelity of what is covered, according to a manual written for
the study detailing each session. A Cognitive Behavioral Therapy (CBT)-certified
practitioner will be leading the sessions. Parents will complete study questionnaires
online before the beginning of the first session, after the end of the last session, and
8 weeks after the completion of the interventions. Study materials for each session will
be emailed to parents before the session and the therapist will assign homework practice
based on the handouts to be done between sessions. Only parents attend the zoom groups in
order to minimize introducing heterogeneity and potential distractions by children.
Furthermore, prior studies have suggested that the child's own anxiety is often mediated
by parental anxiety.
Subjects will be recruited from multiple locations in the community through recruitment
flyers posted in clinics. These clinics will include University Health (Truman) Hospital
Hill outpatient medical clinics, University Health (Truman) Lakewood Hospitals outpatient
medical clinics, University Health Behavioral Health outpatient adult and child clinics
at the Healing Canvas, University Health Behavioral Health outpatient adult and child
clinics at Lakewood Counseling Services, Children's Mercy outpatient clinics in downtown
Kansas City (Broadway Boulevard), and Children's Mercy outpatient clinics in Overland
Park, Kansas.
Flyers will provide email contact information for the research coordinator so that
interested parents can obtain more information about the study and, if they remain
interested in participating, reviewing the consent form with the research staff. Those
who consent to participate will be further screened per inclusion and exclusion criteria.
Subjects will then participate in group Cognitive Behavioral Therapy (CBT) via Zoom
meetings.
Analysis:
Statistical analysis will examine any significant differences in baseline scores, score
changes, and retention of effect post-intervention for the group. All analyses will be
two-tailed with alpha set at 0.05. If scale scores are not normally distributed,
non-parametric tests will be used.
