Behavioral Self-Help Intervention for Pediatric Atopic Dermatitis and Eczema Patients

NCT02713035 | Terminated DMC

• 1 other identifier: 2015-0172
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with atopic dermatitis and eczema often struggle with habitual scratching that is not well-controlled even with optimal medical therapy. Our goal is to create a behavioral intervention to help children with eczema reduce scratching. The investigators hope that the intervention will improve clinical outcomes and quality of life, as well as provide an easily implemented way for clinicians to educate patients and parents about behavioral modification techniques.

Conditions

Dermatitis, Atopic; Eczema

Outcome Measures

Primary Outcomes (3)

• SCORAD - Scoring Atopic Dermatitis - change at follow-up 1-4 months later

  widely-used, validated tool for quantifying the extent and severity of eczema. The form is completed by the physician evaluating the patient in the office, and we will plan to complete this measure at both the initial and follow-up visit.

  Baseline and Follow up visit - change at follow-up 1-4 months later

• Index of Itching Intensity and Scratching Activity - change at follow-up 1-4 months later

  5-item self-report questionnaire that assesses current and past week intensity of itching, frequency of scratching behaviors, and excoriations occurring as a result of scratching. This measure will be completed at both the initial and follow-up visit.

  Baseline and Follow up visit - change at follow-up 1-4 months later

• Acceptability and Feasibility Questionnaire- to assess at follow-up 1-4 months later

  The 11-item questionnaire obtains self-report feedback from the parent with regard to: acceptability of the pamphlet, ease of readability, and use of the pamphlet.

  the follow-up visit in 1-4 months to participants who received the self-help intervention

Secondary Outcomes (3)

• Children's Dermatology Quality of Life Index

  Baseline and Follow up visit - change at follow-up 1-4 months later

• Preschool Anxiety Scale - Parent Report (PAS) or the Spence Children's Anxiety Scale-Parent Report (SCAS) - depending on patient age

  Baseline and Follow up visit- change at follow-up 1-4 months later

• Child Anxiety Sensitivity Index - Parent Version

  Baseline and Follow up visit- change at follow-up 1-4 months later

Study Arms (2)

Usual

NO INTERVENTION

Receive standard medical therapy for eczema

Treatment

EXPERIMENTAL

Receive standard medical therapy for eczema plus behavioral self help intervention

Behavioral: Self help intervention

Interventions

Self help intervention BEHAVIORAL

For participants randomized to receive the treatment, the self-help intervention will be briefly described by a member of the clinical staff, and a brief pamphlet will be distributed to the parent or guardian at the end of the visit. The pamphlet describes behavioral strategies for coping with and reducing scratching behaviors. Participants randomly selected to not receive the treatment will not receive the pamphlet at the end of the visit.

Treatment

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children presenting to the pediatric dermatology clinic;
• current or new diagnosis of eczema or AD;
• between the ages of 4 and 12;
• excoriation is reported by the patient or parent or noted by the clinical staff to be a prominent issues within the past month.

You may not qualify if:

• inability to complete English-language questionnaires;
• patients requiring systemic immunosuppressives such as systemic prednisone, methotrexate, azathioprine, mycophenolate mofetil, or cyclosporine;
• Patients with known comorbidities that cause immunodeficiency, such as HIV, treatment with chemotherapy, or genetic syndromes;
• Patients who are being treated by a mental health provider (e.g., counselor, psychologist) or psychiatrist for issues specifically related to excoriation.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

Pavilion Dermatology Suite K

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Stephanie K Jacks, MD

  assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 18, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)