An interventional study of CBT in Parents, sponsored by University of Missouri, Kansas City. Recruiting at 1 site in United States. Open to participants aged 18 Months to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by University of Missouri, Kansas City · Not applicable, Interventional, and Treatment
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.
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.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 10 is below the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University of Missouri, Kansas City is the lead sponsor of 48 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
The Cognitive Behavioral Therapy (CBT) groups will be 6 weekly one-hour parent groups run by a Cognitive Behavioral Therapy (CBT) therapist according to a Cognitive Behavioral Therapy (CBT) manual focusing on anxiety and depression related to having a child with food allergies.
Behavioral: CBT
Virtual CBT groups
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 weeks
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 weeks
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 weeks
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 weeks
Plan to share: No
Started Jun 2023 (actual). Primary completion is estimated for Dec 2025, 30 months after the start.
Of 150 non-industry interventional studies with no phase under Hypersensitivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 30 months is above that.
Counting every sponsor, half of 174 studies reached it within 20 months; a quarter within 5 and three quarters within 41.
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University of Missouri, Kansas City