Testing a Novel Parent-Based Treatment for Adolescent Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Mean Pediatric Anxiety Rating Scale (PARS) score
研究概览
简要总结
This study aims to test the efficacy of a parent-only approach to treating anxiety disorders in adolescents: SPACE (Supportive Parenting for Anxious Childhood Emotions). The comparator is another parent-based approach, PES (Parent Education and Support). The study design is a randomized controlled trial with 2 treatment arms and 3 assessment points (pre, post, and follow-up) using questionnaire data and clinical interviews.
详细描述
The primary objective is to examine if SPACE is more efficacious than PES in reducing adolescent anxiety symptoms. The secondary objective is to examine if SPACE produces greater change than PES in improving family accommodation and family functioning.
SPACE and PES will be delivered over 12 sessions: Sessions 1-6 (once weekly), a mid-treatment assessment, Sessions 7-12 (once weekly), and a Post-treatment assessment.
Sessions can be attended in person or via Zoom.
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
- None
盲法说明
Adolescent participants and their parents will be enrolled.
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for a primary DSM-5 AD, including separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, specific phobia, panic disorder, and agoraphobia (determined by the ADIS-C/P).
- •Cease all other psychosocial treatment, upon consultation with the project staff and service provider.
- •Not currently use any psychotropic medication, other than a stable dose (i.e., same dose for a minimum of 6 months prior to enrollment; no changes during course of the study) of a stimulant medication or selective serotonin reuptake inhibitor (SSRI).
- •Have an eligible and willing participating parent (see parent exclusions below).
排除标准
- •Adolescent:
- •Meet criteria for any DSM-5 disorder more impairing than the most impairing AD (determined by the ADIS-C/P).
- •Have any of the following disorders: autism spectrum disorder; intellectual disability; neurocognitive disorders; bipolar disorder; schizophrenia and other psychotic disorders; and alcohol and substance use disorders (determined by the Health History Form and ADIS-C/P).
- •Report a suicide attempt in the last 3 months, or current suicide intent and plans (determined by the ASQ).
- •Be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services.
- •Not have sufficient proficiency with the English language to complete assessments.
- •Have any of the following: intellectual disability; neurocognitive disorders; untreated bipolar disorder; untreated schizophrenia and other psychotic disorders; and untreated alcohol and substance use disorders (determined by the Health History Form).
- •Not be living with the adolescent at least 50% of the time for at least one year prior to enrollment.
- •Not have sufficient proficiency with the English language to complete assessments and treatment.
研究组 & 干预措施
Supportive Parenting for Anxious Childhood Emotions (SPACE)
A parent-only approach to treating anxiety disorders in adolescents delivered over 12 sessions.
干预措施: Supportive Parenting for Anxious Childhood Emotions (SPACE) (Behavioral)
Parent Education and Support (PES)
Parent-based approach comparator arm delivered over 12 sessions.
干预措施: Parent Educational Support (PES) (Behavioral)
结局指标
主要结局
Mean Pediatric Anxiety Rating Scale (PARS) score
时间窗: Week 1 and 14
This scale measures anxiety symptoms on 7 dimensions (e.g., avoidance, severity) from 0 ("minimal") to 5 ("extreme"). Total scores range from 0 - 35. Higher scores indicate greater anxiety severity.
Mean Screen for Child Anxiety Related Emotional Disorders (SCARED-C/P) score
时间窗: Week 1, 7 and 14
This scale assesses adolescent anxiety symptoms on a 3-point scale (0 "not true/hardly ever true" to 2 "very true/often true") with total score range = 0 - 82. Higher scores suggest greater anxiety symptoms.
Mean Child Anxiety Impact Scale (CAIS-C/P) score
时间窗: Week 1 and 14
This scale assesses adolescent anxiety that specifically captures impairment related to anxiety across important domains of functioning. Adolescents and parents rate items on a 4-point scale (0 "not at all" to 3 "very much"); total score range = 0 - 81. Higher scores suggest greater anxiety symptoms.
Clinical Global Impression Scale - Severity (CGI-S) and Improvement (CGI-I) scales score
时间窗: Week 1 and 14
This measure will be used to assess overall severity (CGI-S) and improvement (CGI-I) in adolescent anxiety. Total score range for each is 1-7. (Scores of 1 ("very much improved/normal") or 2 ("much improved/borderline ill") indicate a positive treatment response; all other responses are considered negative responses. Higher scores indicate worse outcome.
次要结局
- Mean Family Accommodation Scale - Anxiety (FASA-C/P) score(Week 1, 8 and 14)
- Mean Family Assessment Device - General Functioning Scale (FAD-GF) score(Week 1 and 14)
- Mean Parent Problem Checklist scale score(Week 1 and 14)
- Mean Parent Behavior Inventory - Child and Parent Report (CRPBI/PRPBI) scale score(Week 1 and 14)