Expanding Access to Therapy for Childhood Anxiety Disorders Via Smart Phones - PILOT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
研究概览
简要总结
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting.
详细描述
This research study aims to test the feasibility and effectiveness of using the Mayo Clinic Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting. Therapist will provide CBT to patients with infrequent face-to-face contact and then will examine the acceptability, ease of use and need for contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 7 to 17
- •Primary diagnosis of:
- •social phobia,
- •separation anxiety disorder,
- •panic disorder with and without agoraphobia,
- •specific phobia, or
- •obsessive compulsive disorder
- •A parent or other primary care giver available to participate with the child in all assessment and treatment activities
- •Estimated average intelligence
- •English speaking
排除标准
- •History of and/or current diagnosis of:
- •bipolar disorder,
- •mental retardation,
- •oppositional defiant disorder,
- •selective mutism, or
- •major depressive disorder
- •Current suicidality or recent suicidal behavior
- •Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
- •Starting or changing the dosage of a psychiatric medication in the last two months
研究组 & 干预措施
Face-to-Face w/ Anxiety Coach (FTF-AC)
In this condition therapists will provide 6 to 12 50-minute, face-to-face therapy sessions using Anxiety Coach. The sessions are expected to initially occur weekly and be within the office although the therapist can leave the office to conduct exposure. The therapist is expected to utilize Anxiety Coach within the session, encourage the patient to use the application to complete homework, and review progress in-session via the web-based portal.
干预措施: Mayo Clinic Anxiety Coach (Device)
Minimal Contact w/ Anxiety Coach (MC-AC)
In this condition the therapist will meet with the patient and primary care giver for an initial 50-minute, face-to-face session to provide a tutorial on the use of Anxiety Coach. The therapist is expected to review the patient's progress via the web-based portal and communicate with the patient electronically at least once per week for a total of at least 6 and up to 12 weeks of intervention. Therapists will be allowed 2 additional face-to-face sessions if necessary and still remain in protocol.
干预措施: Mayo Clinic Anxiety Coach (Device)
结局指标
主要结局
Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion
时间窗: Within 5 working days of Treatment Completion
The Pediatric Anxiety Rating Scale (PARS) is an interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.
次要结局
- Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview(Within 5 working days of Treatment Completion)
研究者
Stephen Whiteside
Associate Professor of Psychology
Mayo Clinic