Coaching Children With Anxiety and Autism Through Telehealth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Parent Heart Rate
研究概览
简要总结
This study will examine a telehealth parenting intervention to reduce anxiety in 20 families of children between 4 and 8 years old with autism and anxiety. Caregivers and children complete 12 telehealth treatment sessions. Caregivers and children will complete pre tests, post tests, and 3 month followup assessments that include observations, heart rate monitoring, and caregiver ratings.
详细描述
This study will examine the feasibility and initial efficacy of a telehealth adaptation of a parenting intervention to reduce anxiety (Coaching Approach behavior Leading by Modeling; CALM) amongst 20 families of children between 4 and 8 years old with autism and anxiety. Our time limited telehealth-delivered adaptation of CALM is called CAT (Coaching Children with Anxiety and Autism through Telehealth). The study will utilize an open trial design with pre, post, and 3-month follow-up assessments including observational measures, physiological measures, and caregiver ratings.
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
- 48 Months 至 107 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child participants must:
- •Be between 4:0-8:11 years old
- •Have clinically significant caregiver-report symptoms of anxiety on the Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
- •Have a primary anxiety concern on the Anxiety Disorders Interview Schedule for Autism Spectrum and Developmental Disorders: Parent Version (ADIS/ASA)
- •Have an ASD diagnosis made by a qualified diagnostician
- •Have a cognitive level of 48 months on the Wechsler Preschool & Primary Scale of Intelligence-Fourth Edition (WPPSI-IV; ages 2:6-7:7) or the Wechsler Intelligence Scale for Children-Fifth Edition (WISC-V; ages 6:0-16:11)
- •Caregiver participants must:
- •Have access to a computer, tablet, or phone with a camera and Wi-Fi access
排除标准
- •Primary concern other than anxiety as measures on the ADIS/ASA
研究组 & 干预措施
CAT
Participants will receive behavioral treatment for anxiety.
干预措施: CAT (Behavioral)
结局指标
主要结局
Parent Heart Rate
时间窗: Pre to Post (~14 weeks)
Change in heart rate during structured play interaction from pre to post
Child Heart Rate
时间窗: Pre to Post (~14 weeks)
Change in heart rate during structured play interaction from pre to post
Parent Anxiety Symptoms as assessed by GAD-7
时间窗: Pre to Follow-up (~26 weeks)
The Generalized Anxiety Disorder (GAD-7) is a 7-item screening tool to assess for adult anxiety. Parents score their anxiety symptoms on a 0-3 frequency scale. The GAD-7 yields a total raw score for level of anxiety and a normed T-score with higher scores indicating higher levels of anxiety. The cut-off for clinical significance is a raw score of 8.
Change in Child Anxiety Symptoms as assessed by PRAS-ASD
时间窗: Pre to Follow-up (~26 weeks)
The Parent Rated Anxiety Scale for ASD (PRAS-ASD) is a 25-item measure. Parents score severity of various anxiety symptoms on a scale of 0-3. The PRAS-ASD yields a total raw score for severity of anxiety and a normed T-score with higher scores indicating higher anxiety severity. The cut-off for clinical significance is a raw score of 44.
Change in Parent Accommodation as assessed by FAS-A
时间窗: Pre to Follow-up (~26 weeks)
The Family Accommodation Scale-Anxiety (FAS-A) is a 9 item measure. Parents score the amount that they accommodate their child's anxiety on a 0-4 frequency scale. The FAS-A yields a total raw score for accommodations and a normed T-score with higher scores indicating more accommodations.
Parent Respiratory Sinus Arrhythmia as assessed by Actiheart software
时间窗: Pre to Post (~14 weeks)
Change in respiratory sinus arrhythmia during structured play interaction from pre to post while participant is wearing Actiheart electrodes. After heart activity is collected, Actiheart software is used to analyze Respiratory Sinus Arrhythmia (RSA)
Change in Parenting Stress as assessed by Parenting Stress Index-Short Form (PSI-SF)
时间窗: Pre to Follow (~26 weeks)
Parents will complete the PSI-SF, a 36-item measure yielding scores for a Total Stress scale. The PSI-SF is a widely used measure in ASD samples and has been used as an outcome measure in PCIT ASD studies. The PSI-SF yields a total raw score for stress level and a percentile score which describes parent stress relative to all parents assessed during the development and testing of the PSI. Scores above 80 are considered high stress scores.
Child Respiratory Sinus Arrhythmia as assessed by Actiheart software
时间窗: Pre to Post (~14 weeks)
Change in respiratory sinus arrhythmia during structured play interaction from pre to post while participant is wearing Actiheart electrodes. After heart activity is collected, Actiheart software is used to analyze Respiratory Sinus Arrhythmia (RSA)
次要结局
- Caregiver Satisfaction with treatment as assessed by Therapy Attitude Inventory (TAI)(Pre to Post (~14 weeks))
研究者
Laura Arnstein Carpenter
Professor
Medical University of South Carolina