A Randomized-controlled Trial of Therapy for Children and Adolescents With Anxiety Disorders and Obsessive Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Change in symptom severity per blinded independent evaluator
研究概览
简要总结
The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety disorders and obsessive compulsive disorder (OCD).
详细描述
The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) through baseline comparisons, to compare effectiveness of individual PCET and individual standard cognitive behavioral therapy (CBT), to compare efficiency of individual PCET and individual standard CBT, to compare effectiveness of group intensive PCET, individual PCET, and individual standard CBT, and acceptability.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blind to condition. The integrity of the blind was evaluated
入排标准
- 年龄范围
- 7 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a DSM-5 anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, agoraphobia, separation anxiety disorder, social and specific phobias, as assessed on the relevant modules of the (MINI-Kids; (Sheehan et al., 2010) by study staff in the PADC.
- •Be appropriate for the PADC standard outpatient therapy program, and be interested in starting outpatient therapy,
- •Have the anxiety disorder as their primary diagnosis,
- •If taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic medication, had no medication changes made at least 8 weeks prior to initiating participation in the study and agree to no changes during the 12 weeks of the study.
排除标准
- •History of and/or current psychosis, autism, bipolar disorder, or current suicidality, or eating disorder as assessed during the initial clinical interview and all available clinical information.
- •Current positive diagnosis in the child's caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives (based on clinical interview).
- •Secondary diagnosis of oppositional defiant disorder or major depression of sufficient severity to prevent anxiety treatment.
- •Severity of symptoms that warrant higher level of care (i.e. intensive, residential, IOP, inpatient)
- •Family is unable to attend weekly sessions (i.e. geographical or scheduling barriers)
- •History of good quality exposure or CBT.
结局指标
主要结局
Change in symptom severity per blinded independent evaluator
时间窗: Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)
Measured by the Clinical Global Impression Scale (GCI-S) rating of severity of psychopathology ranging from 1 (not at all ill) to 7 (extremely ill), with a score of 1 or 2 reflecting no to minimal symptoms
Treatment efficiency
时间窗: post-treatment (approximately 14 weeks)
Number of appointments attended
次要结局
- Change in anxiety symptoms per blinded independent evaluator(Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks))
- Change in symptom severity per parent(Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks))
- Change in symptom severity per child(Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks))
研究者
Stephen Whiteside
Principal Investigator
Mayo Clinic