Promoting Resilience in Teens With ASD
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
研究概览
简要总结
Interventions for Autism Spectrum Disorder (ASD) are almost uniformly costly and time-intensive, blunting dissemination of intervention and stymying opportunities to make scalable impact. This study offers the first pilot randomized controlled trial (RCT) of whether a single session intervention, shown to reduce internalizing problems in typically-developing youth, may improve core and co-occuring symptoms of ASD.
详细描述
Interventions for core and co-occurring symptoms of autism spectrum disorders (ASD) are almost uniformly costly and time-intensive, blunting dissemination of intervention and stymying opportunities to make scalable, population-level impact. One promising solution to this problem is a new class of evidence-based treatments, single-session interventions (SSIs), which have shown remarkable efficacy in treating a range of other developmental psychopathologies. No study to date has examined SSIs in youth with ASD, which, if even marginally effective, could dramatically reduce the cost and expand the public health impact of accessible intervention options for ASD. This study offers the first pilot randomized controlled trial (RCT) of whether an SSI shown to reduce internalizing problems in typically-developing youth may improve core and co-occurring symptoms of ASD.
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
- Double (Participant, Investigator)
盲法说明
Participants in the study will be masked by using Qualtrics built in randomization function.
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Youth between the ages of 11-16 (inclusive) at the time of study participation;
- •Youth with one parent or legal guardian willing to participate in the study (i.e. to be present for the lab visit and to complete questionnaires throughout the study period);
- •Youth speaks English well enough to complete online or virtual based intervention activities;
- •Youth with IQ ≥ 70;
- •Parent or legal guardian speaks English well enough to complete online questionnaires;
- •Youth with SCQ >10;
- •Youth who meet criteria for autism or ASD on the ADOS-2.
排除标准
- •Failure to meet the above inclusion criteria;
- •Intellectual disability (IQ<70), as this may undermine comprehension of intervention materials;
- •Adolescent is non-English speaking;
- •The presence of a known developmental disability aside from ASD that would interfere with study participation;
- •The presence of a significant medical disability or disorder that would interfere with study participation.
结局指标
主要结局
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
时间窗: 3-moth followup
The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) is a valid, reliable tool for assessing executive functioning skills in home and school environments. Changes in BRIEF-2 scores from baseline to the 3-month follow-up assessment will serve as the primary index of intervention effects. The BRIEF-2 will take approximately 10 minutes. Each item on the child form is scored 1-3 (1 = Never; 2 = Sometimes; 3 = Often), yielding a total score between 55 and 165 with a higher total score indicating more severe deficiency. Each item on the parent form is scored 1-3 (1 = Never; 2 = Sometimes; 3 = Often), yielding a total scored between 55 and 165 with a higher total score indicating more severe deficiency.
Children's Depression Inventory-2 (CDI-2)
时间窗: 3-moth followup
Adolescent depressive symptom severity will be assessed using the Children's Depression Inventory-2 (CDI-2) Child and Parent forms. The CDI-2 is a reliable, valid measure of youth depression severity, normed for youth age and sex and yielding raw and T scores. Changes in youth CDI2 scores from baseline to each of the follow-up assessments will serve as the primary index of intervention effects. The CDI-2 will take approximately 15 minutes to complete. Each item on the child form is scored 0-2, yielding a total score between 0 and 56 with a higher total score indicating increased depressive symptomatology and a lower total score indicating decreased depressive symptomatology. Each item on the parent form is scored 0-3, yielding a total score between 0 and 51 with a higher score indicating increased depressive symptomatology and a lower total score indicating decreased depressive symptomatology.
次要结局
- Multidimensional Anxiety Scale for Children-2 (MASC-2)(3-month followup)
- Brief Symptom Inventory 18 (BSI-18)(3-month followup)
- Primary Control Scale for Children (PCSC)(3-month followup)
- Implicit Personality Theory Questionnaire (ITPQ)(3-month followup)
- Secondary Control Scale for Children (SCSC)(3-month followup)
- Social Responsiveness Scale-2 (SRS-2)(3-moth followup)
- The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report(3-month followup)
研究者
Matthew Daniel Lerner
Associate Professor
Stony Brook University