Behavioral Self-Help Intervention for Pediatric Atopic Dermatitis and Eczema Patients
|ClinicalTrials.gov Identifier: NCT02713035|
Recruitment Status : Terminated (moved to new institution)
First Posted : March 18, 2016
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic Eczema||Behavioral: Self help intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: Usual
Receive standard medical therapy for eczema
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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713035
|United States, Mississippi|
|Pavilion Dermatology Suite K|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Stephanie K Jacks, MD||assistant professor|