A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from Baseline in child reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED)
研究概览
简要总结
The goal of this clinical trial is to compare two school based interventions to manage anxiety in autistic students. The main question[s] it aims to answer are: 1) Compare the effectiveness of Facing Your Fears-School Based Program (FYF-SB) with Zones of Regulation (ZOR) on anxiety reduction and emotion regulation; and 2) examine the feasibility and satisfaction of FYF-SB and ZOR, according to students, caregivers and school providers. Autistic students with anxiety between 8-14 years will be randomized to either FYF-SB and ZOR. They will participate in one of the programs for 12 weeks and pre, post and follow-up measures will occur.
详细描述
Background and Significance: Anxiety is very common for autistic youth and can significantly limit functioning and full participation across settings. In school, anxiety may negatively impact students' attendance, school performance, peer relationships and extracurricular participation. Unfortunately, autistic youth have experienced long-standing difficulty accessing mental health care in community settings, and this difficulty is even more pronounced for youth from historically underserved racial and ethnic backgrounds. Cognitive-behavioral therapies (CBT) are evidence-based practices that are effective for anxious children with and without autism but have not yet been consistently available in schools. Schools may be the best location to equitably manage the mental health symptoms of autistic youth. In fact, youth from low-income households and/or other underserved communities are most likely to access services only in school settings. Thus, there is a critical need for evidence-based mental health interventions in schools for autistic students. The primary purpose of the current study is to compare two school-based curriculums: Facing Your Fears - Schools Based (FYF-SB) and Zones of Regulation (ZOR) on meaningful outcomes. The results of this study will not only fill a significant gap in the literature but will provide practical information about the strengths and weaknesses of each program so that school leaders and other stakeholders can make informed decisions about program selection for autistic students.
Study Aims. Aim 1: Compare the effectiveness of FYF-SB and ZOR for 200 school-aged autistic students with interfering anxiety.
Compare the effectiveness of FYF-SB and ZOR on: (a) symptoms of anxiety (primary) and emotion dysregulation (co-primary) as rated by caregivers, students, teachers, and masked research staff; and (b) functional outcomes of priority to stakeholders, including school attendance, disciplinary action, and academic participation (secondary). Hypothesis: Students who received FYF-SB will show greater reduction of anxiety compared to students who received ZOR.
Aim 2. Compare the acceptability, appropriateness, and feasibility of FYF-SB and ZOR via a mixed methods approach with students, caregivers and school providers to aid in decision-making regarding program selection (Secondary). Following intervention completion, participants will complete measures on acceptability, appropriateness, and feasibility of either FYF-SB or ZOR. In addition, a purposive subset of participants will participate in exit interviews to understand outcomes of interest, including potential harms linked with either FYF-SB or ZOR.
Aim 3. Examine autism symptom severity and anxiety symptoms severity as moderators of treatment response. This exploratory aim may help answer questions regarding which program could work best for which students.
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 will be masked to condition and collect post- intervention data.
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •There are 3 groups of participants: students, caregivers and interdisciplinary school providers:
- •Inclusion criteria for students ages 8-14:
- •known medical diagnosis of ASD OR educational identification of ASD OR suspected ASD
- •clinical anxiety according to either student, parent or teacher report
- •clinically significant impairment (T-score above 70) in reciprocal social behavior according to the Social Responsiveness Scale - Second Edition (SRS-2).
排除标准
- •for students
- •known intellectual disability
- •significant behavior or psychiatric challenge that prevents them from participation in small group activities
- •lack of parent or caregiver permission for participation
- •Inclusion Criteria for Caregivers of students 8-14
- •legal guardian of a student who meets inclusion criteria defined above
- •Inclusion criteria for Interdisciplinary school providers (ISPs).
- •degreed professionals in one of the following: education (special or general education), school psychology, counseling, social work, speech/language pathology, occupational or physical therapy OR paraprofessional who assist ISPs
- •working with autistic students with anxiety
- •be able to complete study requirements including attending the training workshops, delivering at least 80% of the program they were randomized to, and participating in 80% of bi-monthly consultation sessions with the research team.
- •Exclusion criteria ISPs
- •if they are unable to participate in the trainings, deliver the program they are assigned to, or participate in any of the consultation visits
- •if they do not work with students with autism and anxiety
研究组 & 干预措施
Facing Your Fears - School Based
Facing Your Fears-School Based (FYF-SB) is a 12 week school based group program comprised of psychoeducation (somatic management, development of positive self-statements and strategies for managing emotions), and graded exposure (facing fears a little at a time).
干预措施: Facing Your Fears - School Based (Behavioral)
Zones of Regulation
Zones of Regulation (ZOR) focuses on four different emotional states called "zones." Each zone is represented by different colors that represent different levels of emotions or arousal. ZOR includes psychoeducation about emotions and emotional states (e.g., reading facial expressions, identifying triggers for emotion dysregulations, using emotion regulation tools) and problem-solving strategies. In ZOR, students are also taught emotion regulation strategies (e.g., "calming", "cognitive" and "sensory" strategies) to stay in a specific zone and/or to move from one zone to another.
干预措施: Zones of Regulation (Behavioral)
结局指标
主要结局
Change from Baseline in child reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED)
时间窗: baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention
The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents, to be completed separately by caregivers and students. A total score, as well as cutoffs for specific domains of anxiety (e.g., social, generalized) are obtained. A total score of 25 or higher is clinically significant. Scores range from 0-82 and higher scores indicate a worse outcome.
Change from Baseline in parent reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED)
时间窗: baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention
The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents, to be completed separately by caregivers and students. A total score, as well as cutoffs for specific domains of anxiety (e.g., social, generalized) are obtained. A total score of 25 or higher is clinically significant. Scores range from 0-82 and higher scores indicate a worse outcome.
Change from Baseline in anxiety on the clinician-administered Pediatric Anxiety Rating Scale - Autism Spectrum Disorder (PARS-ASD)
时间窗: Baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention
The PARS-ASD is a clinician administered semi-structured interview to assess anxiety symptoms and severity. The PARS-ASD will be administered by an independent evaluator (IE) masked to condition. It includes: a Symptom Checklist and five Severity Items. The Symptom Checklist covers social anxiety, separation anxiety, generalized anxiety, panic, specific phobia, and other anxiety symptoms. The severity of symptoms is examined by assessing the frequency and pervasiveness of anxiety, as well as the extent to which the child avoids anxiety provoking situations (e.g., behavioral manifestations of anxiety).
次要结局
- Change from Baseline in teacher reported emotion regulation and reactivity on the Emotion Dysregulation Inventory (EDI)(baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention)
- Change from Baseline in child reported social competence and emotion regulation on the Emotion Regulation Index for Children and Adolescents (ERICA)(baseline, within 4 weeks post-intervention and 6 months after completion of the intervention)
- Change from Baseline in teacher reported prosocial behavior and psychopathology on the Strengths and Difficulties Questionnaire (SDQ).(baseline, within 4 weeks post-intervention and 6 months after completion of the intervention)
- Change from Baseline in parent reported emotion regulation and reactivity on the Emotion Dysregulation Inventory (EDI)(baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention)
- Change from Baseline in child reported emotion regulation and reactivity on the Emotion Dysregulation Inventory (EDI)(baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention)
- Change from Baseline in teacher reported anxiety on The School Anxiety Scale - Teacher Report (SAS-TR)(baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention)
- Change from Baseline in parent reported prosocial behavior and psychopathology on the Strengths and Difficulties Questionnaire (SDQ).(baseline, within 4 weeks post-intervention and 6 months after completion of the intervention)
- Change from Baseline in child reported prosocial behavior and psychopathology on the Strengths and Difficulties Questionnaire (SDQ).(baseline, within 4 weeks post-intervention and 6 months after completion of the intervention)