A Single-Session Intervention for Families on Waitlists for Child Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
研究概览
简要总结
Lengthy wait times to access treatment for youth anxiety disorders is a critical issue. To help address this issue, investigators will pursue the following aims in N = 65 families on waitlists for outpatient youth anxiety psychosocial treatment. Aim 1 Pilot Phase: Develop and pilot a single session intervention (SSI) tailored for families on waitlists for outpatient psychosocial treatment for youth anxiety disorders. Investigators will pilot the single session intervention (SSI) with N = 5 families and use cognitive response interviewing to obtain data from parents and children, ensuring the content is understandable and accessible. The SSI will include psychoeducation on the cognitive behavioral conceptualization of anxiety, introduction to self-regulation strategies to manage physiological manifestations of anxiety, and cognitive restructuring of anxiogenic thoughts. The SSI will also involve parents and present strategies on how parents can support their children in managing anxious feelings and thoughts. Investigators will refine the SSI based on these data. Following the Pilot Phase, investigators will enroll an additional N = 60 families and randomize them to either the SSI (n = 30) or waitlist control (n = 30). Aim 2 Test Phase Acceptability, and Satisfaction: Examine acceptability of the refined SSI, as well as satisfaction with the SSI. Investigators hypothesize that users will find the module to be acceptable and will report high satisfaction. Aim 3 Test Phase Anxiety Outcomes: Demonstrate reductions in youth anxiety symptom severity. Investigators hypothesize that anxiety symptom severity and impairment will be significantly lower among youth who receive the refined SSI relative to youth on waitlist control. The main risk or discomfort from this research is that participants might feel uncomfortable answering questions about their behavior and feelings. Another possible risk is breach of confidentiality that could identify a participant as having elevated levels of anxiety. The benefits of this SSI would include increasing accessibility and scalability of treatment for youth anxiety disorders. Overall, this study will provide critically needed data to advance resource efficient treatment options for youth anxiety disorders.
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between ages 7 and 17 years
- •Endorse clinically elevated anxiety symptoms on either parent or youth report, as indicated by a score > 25 on the Screen for Child Anxiety and Related Emotional Disorders-Child or Parent Versions (SCARED-C/P).
排除标准
- •Parent report of past diagnosis of Autism Spectrum Disorder, Intellectual Disability, Bipolar Disorder, Tourette's Disorder, Psychotic Disorders, or Substance Use Disorders
- •Show high likelihood of hurting themselves or others
- •Not having access/connectivity needed for telehealth video conferencing to complete the module.
结局指标
主要结局
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
时间窗: 4 weeks after first session
Follow up parent rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up
时间窗: 4 weeks after first session
Follow up child rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment
时间窗: 1 week after first session
Posttreatment parent rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.
Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment
时间窗: 1 week after first session
Posttreatment child rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up
时间窗: 4 weeks after first session
Follow up parent rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up
时间窗: 4 weeks after first session
Follow up child rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.
次要结局
- Child Anxiety Impact Scale - Child Version at Posttreatment(1 week after first session)
- Program Feedback Scale - Parent Report(1 week after first session)
- Child Anxiety Impact Scale - Parent Version at Posttreatment(1 week after first session)
- Child Anxiety Impact Scale - Parent Version at Follow Up(4 weeks after first session)
- Child Anxiety Impact Scale - Child Version at Follow Up(4 weeks after first session)
- Family Accommodation Scale Anxiety - Parent Version at Posttreatment(1 week after first session)
- Family Accommodation Scale Anxiety - Child Version at Posttreatment(1 week after first session)
- Family Accommodation Scale Anxiety - Parent Version at Follow Up(4 weeks after first session)
- Family Accommodation Scale Anxiety - Child Version at Follow Up(4 weeks after first session)
- Client Satisfaction Questionnaire - Parent Report at Posttreatment(1 week after first session)
- Client Satisfaction Questionnaire - Youth Report at Posttreatment(1 week after first session)
- Screen for Child Anxiety Related Emotional Disorders - Child Version at Pre(first session at baseline)
- Screen for Child Anxiety Related Emotional Disorders - Parent Version at Pre(first session at baseline)
- Child Anxiety Impact Scale - Parent Version at Pre(first session at baseline)
- Child Anxiety Impact Scale - Child Version at Pre(first session at baseline)
- Child Anxiety Impact Scale - Parent Version at Posttreatment(1 week after first session)
- Child Anxiety Impact Scale - Child Version at Posttreatment(1 week after first session)
- Child Anxiety Impact Scale - Parent Version at Follow Up(4 weeks after first session)
- Child Anxiety Impact Scale - Child Version at Follow Up(4 weeks after first session)
- Family Accommodation Scale Anxiety - Parent Version at Pre(first session at baseline)
- Family Accommodation Scale Anxiety - Child Version at Pre(first session at baseline)
- Family Accommodation Scale Anxiety - Parent Version at Posttreatment(1 week after first session)
- Family Accommodation Scale Anxiety - Child Version at Posttreatment(1 week after first session)
- Family Accommodation Scale Anxiety - Parent Version at Follow Up(4 weeks after first session)
- Family Accommodation Scale Anxiety - Child Version at Follow Up(4 weeks after first session)
- Client Satisfaction Questionnaire - Parent Report at Posttreatment(1 week after first session)
- Client Satisfaction Questionnaire - Youth Report at Posttreatment(1 week after first session)
- Program Feedback Scale - Parent Report(1 week after first session)
- Program Feedback Scale - Youth Report(1 week after first session)