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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02713035
Recruitment Status : Terminated (moved to new institution)
First Posted : March 18, 2016
Last Update Posted : February 19, 2018
Information provided by (Responsible Party):
Stephanie jacks, University of Mississippi Medical Center

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Eczema Behavioral: Self help intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Self-Help Intervention for Pediatric Atopic Dermatitis and Eczema Patients
Study Start Date : March 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
No Intervention: Usual
Receive standard medical therapy for eczema
Experimental: Treatment
Receive standard medical therapy for eczema plus behavioral self help intervention
Behavioral: Self help intervention
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.

Primary Outcome Measures :
  1. SCORAD - Scoring Atopic Dermatitis - change at follow-up 1-4 months later [ Time Frame: Baseline and Follow up visit - 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.

  2. Index of Itching Intensity and Scratching Activity - change at follow-up 1-4 months later [ Time Frame: Baseline and Follow up visit - 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.

  3. Acceptability and Feasibility Questionnaire- to assess at follow-up 1-4 months later [ Time Frame: the follow-up visit in 1-4 months to participants who received the self-help intervention ]
    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.

Secondary Outcome Measures :
  1. Children's Dermatology Quality of Life Index [ Time Frame: Baseline and Follow up visit - change at follow-up 1-4 months later ]
    well-validated measure comprised of 10 items measuring health-related quality of life over the previous week among pediatric dermatology patients

  2. Preschool Anxiety Scale - Parent Report (PAS) or the Spence Children's Anxiety Scale-Parent Report (SCAS) - depending on patient age [ Time Frame: Baseline and Follow up visit- change at follow-up 1-4 months later ]
    The PAS and the SCAS are well-validated, self-report measures that are commonly utilized for the clinical assessment of anxiety symptoms in children. The PAS-Parent Version is validated to assess symptoms among children between 3 and 5 years, and the SCAS is utilized for children between 6 and 18 years. The measures are not diagnostic instruments, but indicate the severity of a range of anxiety symptoms. The PAS is completed by a parent and includes 34 items that assess anxiety symptoms on a 0 (not true at all) to 4 (Very often true) scale. Similarly, the SCAS-Parent Version is a 39-item scale measuring child anxiety on six different domains. The items are rated by the parent on a likert scale from 0 (Never) to 3 (Always). Total and subscale scores are computed by adding the corresponding items.

  3. Child Anxiety Sensitivity Index - Parent Version [ Time Frame: Baseline and Follow up visit- change at follow-up 1-4 months later ]
    18-item measure that assesses fear of anxiety symptoms in children per parent report. Anxiety sensitivity is a well-supported transdiagnostic factor that contributes to mental health and health conditions in children and adults. Items are rated by the parent on a three-point scale (0 = none; 1 = some; 2 = a lot). An example question is "It scares my child when she/he feels nervous." The total score is computed by adding the items

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02713035

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United States, Mississippi
Pavilion Dermatology Suite K
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
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Principal Investigator: Stephanie K Jacks, MD assistant professor

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Responsible Party: Stephanie jacks, Assistant Professor, University of Mississippi Medical Center Identifier: NCT02713035     History of Changes
Other Study ID Numbers: 2015-0172
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be reviewed by a member of the research team the same week it is collected in order to ensure completion and clarity. The research team will maintain an updated data tracking form indicating when participant data are collected, entered, and verified, as well as any corrections that are needed. The PI, clinical staff, and trained bachelors- or Master-level staff will collect the data, and will thus have access to participant identities. However, the investigators will safeguard against breaches of confidentiality by coding participant data by ID number rather than by name, and by keeping information linking these ID numbers to specific individuals in a locked file cabinet accessible only to project staff. Further, individuals will not be identified by name (nor will any identifying information be offered) when results from data are disseminated.

Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases