A Pilot Telehealth Parent-Mediated Intervention Targeting Insistence on Sameness for Autistic Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.
研究概览
简要总结
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6:0 to 10:11 years at the time of consent
- •diagnosed with ASD (based on history, review of available medical records including diagnostic testing completed by psychologist)
- •IQ > or = 75 (based on history, review of available medical records)
- •report three or more family accommodations for insistence on sameness based on screening measures
- •English-speaking parent and youth able to consistently participate in study procedures
排除标准
- •children with significant hearing, language or motor impairment
- •unstable behavioral and pharmacological treatments (e.g., anxiety medication) to treat anxiety or IS behaviors prior to two months to the start of the study and no anticipated changes in treatments during the course of the trial
- •caregivers who have participated in formal SPACE training
- •concurrent psychosocial treatment for anxiety or Insistence on Sameness
- •children who have a history of prominent school refusal, self-harm, or suicidal ideation
研究组 & 干预措施
Active treatment
Eligible participants that enroll will received 16 week parent based intervention for insistence on sameness
干预措施: Supportive Parenting for Anxious Childhood Emotions (SPACE) for insistence on sameness (IS) (Behavioral)
结局指标
主要结局
Change from baseline in parent rated Dimensional Assessment of Restricted Behavior (DARB) Scores during treatment.
时间窗: Screening, Baseline, Weeks 4, 8, 12, 16 and 2 month follow up
DARB scores measure restricted and repetitive behaviors with higher scores indicating greater intensity.
Change from baseline in clinician rated clinical global impressions scale scores during treatment.
时间窗: Weeks 8, 16 and 2 month follow up
Score Range: 1 = normal, not at all ill; 7 = among the most extremely ill patients; 1 = very much informed since the initiation of treatment; 7 = very much worse since the initiation of treatment.
次要结局
- Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD).(Baseline, Week 16 and 2 month Follow up)
- Change in Emotion Regulation Checklist scores during treatment(Baseline, 16 week)
- Change in Daily Living Skills Scale Scores during treatment(Baseline, 16 week, 2 month Follow up)
- Change in Open Source - Challenging Behavior scores during treatment(Baseline, 16 weeks, 2 month Follow Up)
研究者
Jennifer Phillips
Professor of Psychiatry and Behavioral Sciences
Stanford University