ParentsNCT06138431
Group CBT in Parents of Children With Food Allergy
A study testing CBT in people with Parents, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months to 17 years
- Conditions the study is for
- Parents
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
- Parent can be on stable doses of antidepressants or anxiety medications but all doses must remain stable for 1 month before study and during it as well as for 2 months after the groups are completed: to fill out final questionnaires
- Both parents of a child may enroll but will need to agree to fill out all questionnaires separately without discussing them with each other
Who cannot join
- Parental history of recent suicidal ideation / suicide attempt
- Current Suicidal ideation
- Current substance abuse
- Parent currently in psychiatric treatment and medications being adjusted
- Using OTC anxiety or depression relief, or CBD or medical marijuana
- Parent receiving other therapies or group supports
- Parent unable to attend 6 consecutive weekly group sessions and fill out questionnaires online also 2 months later or does not have access to WiFi.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Health Behavioral Health Canvas Building
Kansas City, Missouri, 64108
Jessica A Hellings, MD, 816-404-6170, Jessica.Hellings@uhkc.org
Carrie Kriz, MS, 816-238-1808, mckinleycr@umkc.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Parents
- Being tested
- CBT
- Keywords
- parents, children, food, allergies, CBT, cognitive, therapy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Virtual CBT groups
| Study group | Role | What they receive |
|---|---|---|
| Virtual Cognitive Behavioral Therapy (CBT) group | Experimental | 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. Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of approximately 10 parents of children with food allergies will receive virtual CBT group therapy via Zoom.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Hellings, University of Missouri, Kansas City
- Investigators
- Jessica Hellings, MD, Principal investigator, University of Missouri-Kansas City and University Health Behavioral HealthStephen Jarvis, MD, Study chair, University Health Behavioral Health, and UMKC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138431
- Sponsor's protocol ID
- 2016886
- Status last verified
- Jan 2025
- First submitted
- 7 Mar 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knibb RC, Barnes C, Stalker C. Parental self-efficacy in managing food allergy and mental health predicts food allergy-related quality of life. Pediatr Allergy Immunol. 2016 Aug;27(5):459-64. doi: 10.1111/pai.12569. Epub 2016 May 3.
PubMed 27019307
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group CBT in Parents of Children With Food Allergy
- ClinicalTrials.gov ID
- NCT06138431
- Acronym / sponsor ID
- 2016886
- Conditions
- Parents
- Keywords
- parents, children, food, allergies, CBT, cognitive, therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of approximately 10 parents of children with food allergies will receive virtual CBT group therapy via Zoom.
| Arm | Type | Receives |
|---|---|---|
| Virtual Cognitive Behavioral Therapy (CBT) group | Experimental | Behavioral: CBTThe 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. |
Who may qualify
- Ages
- 18 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
- Parent can be on stable doses of antidepressants or anxiety medications but all doses must remain stable for 1 month before study and during it as well as for 2 months after the groups are completed: to fill out final questionnaires
Key exclusion criteria (7 listed)
- Parental history of recent suicidal ideation / suicide attempt
- Current Suicidal ideation
- Current substance abuse
- Parent currently in psychiatric treatment and medications being adjusted
- Using OTC anxiety or depression relief, or CBD or medical marijuana
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTVirtual CBT groups | Behavioural | Virtual Cognitive Behavioral Therapy (CBT) group |
Primary outcome
Change in Score of Food Allergy Quality of Life-Parent Burden Questionnaire (FAQL-PB)
Time frame: 14 weeks
17-item instrument, using a 7-point Likert scale ranging from 1 (not troubled) to 7 (extremely troubled) anxieties over the past week.
3 secondary outcomes
Subject Satisfaction Questionnaire
Time frame: 14 weeks
Change in Score of Pediatric Food Allergy Quality of Life Scale
Time frame: 14 weeks
Change in Score of Hospital Anxiety and Depression Scale (HADS)
Time frame: 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 27019307Knibb RC, Barnes C, Stalker C. Parental self-efficacy in managing food allergy and mental health predicts food allergy-related quality of life. Pediatr Allergy Immunol. 2016 Aug;27(5):459-64. doi: 10.1111/pai.12569. Epub 2016 May 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Hellings, MD principal investigator
University of Missouri-Kansas City and University Health Behavioral Health
Stephen Jarvis, MD study chair
University Health Behavioral Health, and UMKC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Parents, run by University of Missouri, Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Hellings, MD (816-404-6202, Jessica.Hellings@uhkc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Score of Food Allergy Quality of Life-Parent Burden Questionnaire (FAQL-PB) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.