Brain Response Associated With Parent-based Treatment for Childhood Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Pediatric Anxiety Rating Scale (PARS)
研究概览
简要总结
This study aims to investigate whether a parent-based treatment for childhood anxiety disorders engages child brain circuitry implicated in children's reliance on parents to reduce anxiety (R61), and whether change in child brain circuitry is associated with reduction in child anxiety (R33).
详细描述
Specific Aims: Anxiety disorders impact up to one-third of children, cause tremendous suffering, increase risk for psychiatric and medical morbidity, impair school and social functioning, and cost billions of dollars each year. Data consistently show that child anxiety is characterized by amygdala hyperactivity and deficits in prefrontal control of the amygdala. Emerging data link these disruptions to anxious children's over-reliance on parents for amygdala-medial prefrontal cortex (mPFC) engagement and anxiety reduction.
In the first phase of this study we aim to demonstrate that an entirely parent-based psychosocial treatment with no child involvement, Supportive Parenting for Anxious Childhood Emotions (SPACE), engages an amygdala-mPFC target in anxious children, lessening child reliance on parents to reduce amygdala reactivity.
Cross-species neurobiological evidence indicates that parental presence reduces amygdala reactivity and activates the mPFC to reduce offspring anxiety. In humans we recently demonstrated parental presence increases functional connectivity between their child's mPFC and amygdala, reducing the child's amygdala reactivity and anxiety. In a healthy sample, parental engagement of child amygdala-mPFC connectivity was linked to the child's reliance on parents for help with anxiety. Data from clinically anxious children likewise show parental presence engages child mPFC, and data we collected since our previous submission demonstrate that parental presence reduces amygdala reactivity in clinically anxious children.
Offspring's natural reliance on parents for anxiety reduction is magnified in clinically anxious children. Parents become deeply enmeshed in their child's symptoms through the process of family accommodation, defined as change in parents' behavior to help the child avoid or alleviate anxiety. In clinically anxious children, 90% report depending on parents to reduce their anxiety, and 97% of parents report accommodating their anxious child's symptoms. These cross-generational patterns of parental entanglement in their child's anxiety symptoms contribute to the immense burden, distress, and costs of pediatric anxiety (e.g., parents missing work to be with their anxious child). Anxious children's reliance on parents for anxiety reduction may disrupt the child's ability to independently reduce amygdala reactivity and anxiety.
We developed SPACE to translate these neurobiological and clinical research findings into a manualized parent-based treatment focused on reducing family accommodation in parents of anxious children. Preliminary data from a randomized clinical trial show that after 12 weeks of parents receiving SPACE (N=29), with no therapist-child contact, family accommodation and child anxiety were significantly reduced. We propose that SPACE engages anxious children's amygdala-mPFC circuitry, lessening their reliance on parents to reduce amygdala reactivity.
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
Assessments will conducted by independent evaluators, blind to treatment condition.
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prepubertal
- •Clinical diagnosis of primary anxiety disorder
- •Must not have another mental illness more impairing than the most impairing anxiety disorder
- •IQ of at least 80.
排除标准
- •Neurological disorders (including seizures)
- •Organic mental disorders, psychotic disorders, or pervasive developmental disorders
- •High likelihood of hurting themselves or others
- •Current psychosocial or psychopharmacological treatment
- •History of neurological illness or head injury with loss of consciousness > 5 minutes
- •Vision or physical disability that interferes with seeing stimuli presented briefly on computer screen and/or clicking a mouse button rapidly and repeatedly
- •Contraindications for MRI scanning (e.g., metal implants, pacemakers, braces, claustrophobia, pregnancy, weight > 250 pounds).
研究组 & 干预措施
Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
干预措施: Supportive Parenting for Anxious Childhood Emotions (Behavioral)
Parent Educational Support (PES)
Parent Educational Support: 12 sessions with parents
干预措施: Parent Educational Support (Behavioral)
Cognitive Behavioral Therapy (CBT)
Cognitive-Behavioral Therapy: 12 sessions with child
干预措施: Cognitive-Behavioral Therapy (Behavioral)
结局指标
主要结局
Pediatric Anxiety Rating Scale (PARS)
时间窗: 12 weeks
The PARS is a clinician-administered measure of anxiety severity in children and adolescents. Total scores on PARS are used as indicator of anxiety severity. Total scores range from 0-35, with higher scores indicating more severe anxiety.
Change From Baseline Anxiety Severity on the Pediatric Anxiety Rating Scale (PARS) at Week 12.
时间窗: Baseline and 12 weeks
The PARS is a clinician-administered measure of anxiety severity in children and adolescents. Total scores on PARS are used as indicator of anxiety severity. Total scores range from 0-35, with higher scores indicating more severe anxiety.
次要结局
- Multimodal Anxiety Scale for Children (MASC)(12 weeks)
- Change From Baseline Anxiety Severity on the Multimodal Anxiety Scale for Children (MASC) at Week 12.(Baseline and 12 weeks)
