Harnessing Technology to Extend the Reach of Supported Care for Families Affected by Early Child Social 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
- Clinical Global Impressions Scales - Severity and Improvement (CGI-S/I)
研究概览
简要总结
The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control and will complete a course of I-CALM after the waitlist period. Outcomes will be assessed via structured diagnostic interviews and parent-report questionnaires.
详细描述
The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control, followed by I-CALM treatment.
SPECIFIC AIMS:
- Aim 1: To evaluate I-CALM efficacy for reducing early child social anxiety symptoms and related impairments and for improving child and parent quality of life.
- Aim 2: To examine the extent to which I-CALM helps families overcome traditional barriers to effective care, including geographic barriers and regional professional workforce shortages in social anxiety expert care.
- Aim 3: To evaluate the feasibility, acceptability, and satisfaction of I-CALM from the perspective of treated\ families, and lay the foundation for a large Florida statewide implementation of I-CALM for early social anxiety.
RATIONALE: Despite progress in supported programs for child social anxiety disorder, gaps persist between treatment in specialty clinics and services broadly available in the community. Although considerable advances show social anxiety is treatable when appropriate CBT is available, barriers interfere with the broad provision of quality care. Few sufferers receive services, and those who do receive services do not necessarily receive evidence-based care. Many U.S. counties have no psychologist, psychiatrist, or social worker, let alone professionals trained in supported social anxiety treatments. When effective programs are available, transportation issues constrain access, with large proportions of patients reporting that services are too far away or they have no way to get to a clinic. Expert providers cluster around metropolitan regions and major academic hubs, leaving considerable numbers of youth without access to supported service options. Youth from low-income or remote and rural communities are particularly unlikely to receive appropriate care. High rates of stigma-related beliefs further constrain service utilization, with many reporting negative attitudes about visiting a mental health clinic.
An Internet-delivered, real-time intervention for the remote treatment of early child social anxiety disorder has the potential to meaningfully extend the reach of effective social anxiety treatment for underserved youth and can serve as the critical foundation upon which to build a larger-scale statewide implementation of early social anxiety treatment. Moreover, treating youth in their homes can overcome stigma-related concerns that interfere with families attending services at a psychiatric clinic, and treatment gains may be more generalizable and ecologically valid as services are provided to youth in their natural settings.
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
Independent evaluators masked to each participating family's treatment condition will perform all structured diagnostic interviews and generate responder status data
入排标准
- 年龄范围
- 3 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 3-8 years old, and at least one primary caregiver
- •Child has diagnosis of social anxiety disorder (as assessed in pre-treatment assessment).
- •Child and parent both speak either English or Spanish fluently
- •Family's home is equipped with computing device and high-speed internet
排除标准
- •Child has emotional/behavioral problem more impairing than difficulties captured by an anxiety disorder diagnosis.
- •Child receiving medication or other psychotherapy to manage emotional difficulties
- •History of severe physical or mental impairments (e.g., intellectual disability, deafness, blindness, pervasive developmental disorder) in child or participating caregiver(s)
- •Child is a ward of the state
结局指标
主要结局
Clinical Global Impressions Scales - Severity and Improvement (CGI-S/I)
时间窗: 5 minutes
CGI-S/I is the most widely used clinician-rated measure of treatment-related changes in functioning (Guy \& Bonato, 1970) and will be completed by IEs in the present study. The CGI-S score rates illness severity on a 7-point scale, ranging from 1 ("normal") to 7 ("among the most severely ill patients"). The CGI-I rates clinical improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse").
次要结局
- Spence Children's Anxiety Scale(15 minutes)
- Family Accommodation Scale- Anxiety(10 minutes)
- Anxiety Disorders Interview Schedule for Children (ADIS-C/P)(2 hours)
- Child Anxiety Impact Scale(5 minutes)
- Working Alliance Inventory(10 minutes)
- Client Satisfaction Questionnaire(3 minutes)
- Children's Global Assessment Scale(5 minutes)
- Family Burden Assessment Scale(5 minutes)
- Family Accommodation Checklist and Interference Scale(10 minutes)
- Child Behavior Checklist(25 minutes)
研究者
Jonathan S. Comer
Professor of Psychology
Florida International University
