Using Smartphones to Enhance the Treatment of Childhood Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- PARS Treatment response
研究概览
简要总结
The primary goal of this research study is to develop an interactive smartphone app that could be used to increase the effectiveness of talk therapy such as cognitive behavioral therapy (CBT) for child anxiety.
详细描述
Boys and girls between the ages of 9-14 who have anxiety and a parent or caregiver are being asked to participate in this study. Interested participants who contact the study will be asked to undergo a brief phone pre-screen to determine initial eligibility.
After completing a phone pre-screen, potential participants for the Phase 2 trial will be invited to the lab to complete a clinical intake interview. Clinical information will be obtained from parent and child by a trained research staff member. The research staff member will have specific training to a high degree of reliability in conducting the diagnostic interviews relevant to this research study.
Participants that meet study criteria based on the clinical information obtained at the first study visit will be invited to begin a course of Cognitive Behavior Therapy (CBT), an empirically validated talk therapy commonly used to treat children with anxiety. Children will receive individual treatment using the Brief Coping Cat Manual. The Coping Cat program (Kendall 1994) is an empirically supported child-focused CBT treatment for children with anxiety disorders. Throughout the program, children are encouraged to practice techniques learned during therapy sessions through homework or "Show-That-I-Can" (STIC) tasks. Parents attend weekly check-ins and two parent-only sessions. STIC tasks will consist of specific SmartCAT modules in the smartphone app as assigned at the end of each session. Participants might be asked to interact with other children and adolescents or study staff as well as leave the therapy building. This is to allow participants to become more comfortable in situations that make them feel anxious by gradually exposing them to the specific situation. Parents are not treated as co-clients, but are considered consultants to the child's treatment and are asked to provide some collaboration and assistance in exposure planning and homework.
Treatment will be delivered by Masters-level therapists who will have completed training in CBT. They will attend a weekly supervision session with Dr. Silk, with consultation from Dr. Kendall on difficult cases via videoconference. All sessions will be videotaped.
SMARTPHONE PROTOCOL:
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
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be 40 children of either sex ages 9 years, 0 months to 14 years, 11 months with DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and/or Social Phobia (SP) as identified by the Kiddie Schedule of Affective Disorders.
- •The primary caregiver is defined as the person who has the most responsibility for taking care of the child. While this is typically the mother, it can be the father, an adoptive parent or other legal guardian. The primary caregiver must be a legal guardian of the child.
排除标准
- •Requires current ongoing treatment with psychoactive medications other than stimulants.
- •Acutely suicidal or at risk for harm to self or others.
- •Neuromuscular or neurological disorder.
- •Reading level below 80 on the Wide Range Achievement Test-4 (WRAT-4)
- •Medical illnesses or medications taken for an illness as determined by study physicians that would affect study adherence, and subject's emotional state.
- •Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who have primary GAD with co-morbid MDD that is secondary in terms of course and functional impact are not excluded), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or dependence, and ADHD combined type or predominantly hyperactive-impulsive type.
- •Lifetime diagnosis of autism spectrum disorder, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.
结局指标
主要结局
PARS Treatment response
时间窗: 10 weeks
Anxiety severity will be rated by an IE on the Pediatric Anxiety Rating Scale (PARS) (RUPP Study Group, 2002). A total score was computed by summing six items assessing anxiety severity, frequency, distress, avoidance, and interference during the previous week. Treatment response will be defined as a 35% reduction in PARS from pre- to post-treatment.
次要结局
- Absence of diagnosis on K-SADS(10 weeks)
研究者
Jennifer Silk
PhD
University of Pittsburgh