Cognitive Behavioral Therapy for Parents of Children With Food Allergies

Overseen By Carrie Kriz, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri, Kansas City

Must be taking: Antidepressants, Anxiety medications

Must not be taking: OTC anxiety, CBD, Marijuana

Disqualifiers: Suicidal ideation, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

10 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

You can continue taking your current antidepressants or anxiety medications, but the doses must stay the same for one month before the study, during the study, and for two months after it ends. If your medications are being adjusted, you cannot participate.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy (CBT) for parents of children with food allergies?

Research shows that Cognitive Behavioral Therapy (CBT) can effectively reduce anxiety in parents of children with food allergies. A study found that a brief CBT intervention significantly reduced maternal anxiety, and therapists were able to deliver this therapy competently after training. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for parents of children with food allergies?

Cognitive Behavioral Therapy (CBT) is generally considered safe for humans and has been used to help reduce anxiety and stress in parents of children with food allergies. Studies have shown that therapists can be trained to deliver CBT effectively, and it can improve mental health and parenting behaviors without significant safety concerns. ^{1 2 4 6 7}

How does the treatment Cognitive Behavioral Therapy (CBT) for parents of children with food allergies differ from other treatments?

Cognitive Behavioral Therapy (CBT) is unique because it focuses on reducing the psychological impact, such as stress and anxiety, that parents experience due to their child's food allergies, which can improve both the parents' and children's mental health. Unlike other treatments that might focus on the physical management of allergies, CBT addresses the emotional and mental well-being of the caregivers. ^{1 2 4 6 8}

Research Team

Stephen Jarvis, MD

Principal Investigator

University Health Behavioral Health, and UMKC

Jessica Hellings, MD

Principal Investigator

University of Missouri-Kansas City and University Health Behavioral Health

Eligibility Criteria

This trial is for parents over 18 with a child aged 6-17 who has a serious food allergy diagnosed by a doctor. Parents should show signs of anxiety or depression but can be on stable medication for these conditions. They must commit to weekly sessions and follow-ups without current psychiatric treatment changes, substance abuse, or use of certain over-the-counter remedies.

Inclusion Criteria

Both parents of a child can join the study, but they have to answer questions separately without talking to each other about them.

My gender does not affect my eligibility.

My child, aged 6-17, has a serious food allergy diagnosed by a doctor.

Exclusion Criteria

I use over-the-counter remedies or CBD/medical marijuana for anxiety or depression.

Current Suicidal ideation

Current substance abuse

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants engage in 6 weekly one-hour virtual Cognitive Behavioral Therapy (CBT) sessions

6 weeks

6 visits (virtual)

Follow-up

Participants complete follow-up questionnaires to assess retention of effect post-intervention

8 weeks

1 visit (virtual)

Treatment Details

Interventions

• CBT

Trial Overview The study tests if group Cognitive Behavioral Therapy (CBT) via virtual meetings helps reduce anxiety and depression in parents of children with food allergies. Participants are randomly placed into either the CBT group or a wait-list group to compare outcomes.

Participant Groups

Group I: Virtual Cognitive Behavioral Therapy (CBT) group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Missouri, Kansas City

Lead Sponsor

Trials

73

Recruited

34,600+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Cognitive Behaviour Therapy for Mothers of Children with Food Allergy: A Case Series. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Therapy competence in delivering a brief cognitive behavioural therapy intervention to reduce maternal anxiety associated with child food allergy. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Children's Food Allergies: Development of the Food Allergy Management and Adaptation Scale. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Psychotherapeutic Treatment for Psychosocial Concerns Related to Food Allergy: Current Treatment Approaches and Unmet Needs. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Impact of suspected food allergy on emotional distress and family life of parents prior to allergy diagnosis. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Parental anxiety in food allergy: using a cognitive behavioural therapy approach to guide early intervention. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Active treatment for food allergy. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical Management of Psychosocial Concerns Related to Food Allergy. [2018]