Development of a Parent Training Intervention for Pediatric Patients With Medically Unexplained Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1996)
研究概览
简要总结
The purpose of this study is to examine the effects of a parent-only, group-based intervention intended to treat youth with chronic, unexplained medical symptoms such as (but not limited to) chronic fatigue, musculoskeletal pain, headache, and abdominal pain. Prior to and following the intervention, the child and parent(s) will be asked to complete several questionnaires about their well-being and functioning. The investigators predict that participation in this intervention will lead to change in relevant outcomes, including youth symptoms and functional impairment, and parenting stress and accommodation of symptoms. The investigators also predict that this group will be acceptable and feasible for parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of medically unexplained symptoms, including: fibromyalgia, chronic fatigue, chronic Lyme disease, irritable bowel syndrome, musculoskeletal pain, headache, abdominal pain and related bowel dysfunction, perceived cognitive impairment, or other nonspecific symptoms
- •Symptoms must have been present for at least 3 months, associated with some degree of impairment (e.g., missing school), and not attributable to a known organic or medical disorder despite adequate evaluation
- •Participants must be proficient or fluent in English
- •Children must live with their participating parent(s) at least 50% of the time
排除标准
- •Presence of a serious medical condition by history, including chronic autoimmune or inflammatory condition
- •Lifetime history of a psychotic disorder, bipolar disorder, Autism, or intellectual disability (Note: this criterion applies to child and parent(s))
- •Presence of severe emotional or behavioral problems that require a more immediate treatment
结局指标
主要结局
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1996)
时间窗: Post-treatment (6-8 weeks)
The CSQ-8 is an 8-item self-report questionnaire that assesses satisfaction with (i.e., acceptability of) services received. Questions are rated on a response scale of 1("Quite dissatisfied") to 4("very satisfied"). An overall score is calculated by summing the respondent's score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction with/acceptability of treatment.
次要结局
- Clinical Global Impression Scale (CGI; National Institutes of Mental Health, 1985)(Pre-treatment; Post-treatment)
- Child's Report of Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1988)(Pre-treatment; Post-treatment; 3-month follow-up)
- Functional Disability Inventory (FDI; Kashikar-Zuck et al., 2011)(Pre-treatment; Post-treatment; 3-month follow-up)
- Parenting Stress Index, 4th Edition, Short-Form (PSI-4-SF; Abidin, 2012)(Pre-treatment; Post-treatment; 3-month follow-up)
- Children's Depression Inventory (CDI-2; Kovacs, 2011).(Pre-treatment; Post-treatment; 3-month follow-up)
- Family Accommodation Scale - Anxiety (FASA; Lebowitz et al., 2013; Lebowitz, Marin, & Silverman, 2019)(Pre-treatment; Post-treatment; 3-month follow-up)
- The Client Credibility Questionnaire (CCQ; Borkovec & Nau, 1972)(Following 1st group session (1 week))
- Pediatric Quality of Life Inventory (PedsQL; Varni, Seid, & Kurtin, 2001)(Pre-treatment; Post-treatment; 3-month follow-up)
- Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher, Khetarpal, Brent, Cully, Balach, Kaufman, & Neer, 1997)(Pre-treatment; Post-treatment; 3-month follow-up)
- The Symptom Impact Questionnaire-Revised (SIQR; Bennett, Friend, Jones, Ward, Han, & Ross, 2009)(Pre-treatment; Post-treatment; 3-month follow-up)
- Child Anxiety Sensitivity Index (CASI; Silverman, Fleisig, Rabian, & Peterson, 1991)(Pre-treatment; Post-treatment; 3-month follow-up)
- Inventory of Parent Accommodations of Children's Symptoms (IPACS; Harrison, Peterson, Short, & Wetterneck, 2016)(Pre-treatment; Post-treatment; 3-month follow-up)
- Perceived Stress Scale (PSS: Cohen, Kamarck, Mermelstein, 1983)(Pre-treatment; Post-treatment; 3-month follow-up)
- Affective Reactivity Index-Child and Parent versions (ARI-C/P; Stringaris, Goodman, Ferdinando, Razdan, Muhrer, Leibenluft, & Brotman, 2012)(Pre-treatment; Post-treatment; 3-month follow-up)