Behavioral Self-Help Intervention for Pediatric Atopic Dermatitis and Eczema Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- SCORAD - Scoring Atopic Dermatitis - change at follow-up 1-4 months later
研究概览
简要总结
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.
详细描述
Background Psychological interventions for atopic dermatitis (AD) in children are not well-studied, despite the potential benefits, which may include: decreased need for medications and improved long-term control of both dermatologic symptoms as well as other secondary symptoms that may impact quality of life, such as anxiety, insomnia, and psychosocial distress. Chida and colleagues (2007) conducted a meta-analysis of psychological interventions for AD. Of the eight studies that were included in the meta-analysis, only four studies examined pediatric patients. A wide-range of psychological interventions were evaluated, including cognitive-behavioral therapy, stress management programs, aromatherapy massage, psychodynamic therapy, and structured educational programs focusing on a wide range of medical and psychological topics (e.g., nutrition, relaxation). Seven of the eight studies showed some positive effects on measures of eczema severity, scratching/itching, use of topical steroids, and anxiety.
More recently, Ersser and colleagues (2014) evaluated the literature on psychological and educational interventions for AD focusing on studies conducted among children. Ten randomized controlled trials were reviewed, including 9 educational interventions and one study that evaluated a psychological intervention.Particular promise in terms of modest improvement in disease severity and quality of life was noted in a large study (N=992) that utilized a multidisciplinary group education intervention in an inpatient setting. However, the authors of the review concluded that there is a lack of research on this topic. Accordingly, additional studies evaluating psychological and educational interventions are needed. Previous studies have evaluated time- and resource-intensive interventions that may not be practical outside of a randomized controlled trial or a large academic research setting. Nevertheless, adjunctive psychological interventions are promising for reducing symptoms associated with severe dermatologic issues. To address this gap, the current study will evaluate the utility and acceptability of a brief self-help behavioral intervention in a pilot study, which emphasizes the effectiveness of the study design. A brief self-help intervention that utilizes well-supported cognitive and behavioral psychological strategies will be distributed to interested patients and families to augment the standard skin-directed treatments for eczema or AD. The self-help intervention will be distributed to and discussed with a family in less than five minutes in an outpatient clinic setting by clinical staff with no special training in psychology. The target population is children with AD aged 4-12 years with prominent excoriations and their guardians. At the standard 1-4 month follow-up visit, feasibility and acceptability of the self-help intervention will be assessed. Brief evaluations of medical and behavioral symptoms will be conducted at the initial visit and the follow-up.
Purpose The purpose of the current study is to pilot a brief self-help behavioral intervention that will be implemented in conjunction with treatment as usual in children with AD or eczema between the ages of 4 and 12 years. The acceptability and effectiveness of the intervention will be evaluated. The intervention aims to reduce the severity of AD or eczema symptoms and improve the quality of life in children. It is hypothesized that the adjunctive self-help behavioral treatment will reduce the severity of eczema and improve quality of life for patients who receive the intervention compared to patients who only receive standard dermatologic treatment. Additionally, itching intensity, scratching behaviors, and anxiety symptoms will be included as outcome measures.
Specific Aims Aim 1: Pilot a brief self-help behavioral intervention to be delivered to children with eczema or AD and their parents.
Aim 2: Evaluate feasibility and acceptability of a brief self-help behavioral intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual
Receive standard medical therapy for eczema
Treatment
Receive standard medical therapy for eczema plus behavioral self help intervention
干预措施: Self help intervention (Behavioral)
结局指标
主要结局
SCORAD - Scoring Atopic Dermatitis - change at follow-up 1-4 months later
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Stephanie jacks
Assistant Professor
University of Mississippi Medical Center