The Efficacy of Parent Management Training to Treat Irritability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Demonstrate the feasibility of Parent Management Training (PMT) procedures
研究概览
简要总结
The goal of this clinical trial is to see if 12 sessions of a Parent Management Training program can treat irritability in children aged 10-14 years old. The main question it aims to answer are:
- Can a Parent Management Training for parents reduce anger outbursts and cranky moods in their children?
- Can Parent Management Training be done in an outpatient clinic and do parents like it?
Up to 24 families can join this study.
Parent participants will complete 12 sessions of Parent Management Training for Irritability. Each session will be 45-55 minutes weekly. They will also participate in the assessments of their child before, during and after treatment.
Child participants will do assessments before, during and after the Parent Management Training treatment.
详细描述
Up to 24 families will be consented for this Parent Management Training (PMT) to Treat Irritability study in order to meet the aim of having 12 families complete the study. The child and a parent will complete pre-treatment evaluations about the child's mental health, behavior and cognitive functioning. Participants who meet inclusion criteria (age 10-14 with significant irritability) and do not meet exclusion criteria (e.g. Autism, Bipolar disorder, active PTSD, serious medical issues or Intellectual disability) will be invited to join the trial. All participants will receive the 12 PMT sessions from a licensed mental health professional. The PMT sessions will focus on the parents only, but both the parent and child will complete standardized measures and interview with a clinician in the middle of the treatment. After the 12 sessions of PMT, the parent and child will complete a post-treatment assessment. Pre and post treatments assessments will be compared to determine changes in the child's irritability and other areas of functioning.
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
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically significant irritability (Clinician Affective Reactivity Index 30 or greater)
- •parent or guardian with whom the child resides for at least 50% of the time is willing to participate in treatment with the child
排除标准
- •psychiatric instability (danger to self/others, risky substance abuse)
- •current active Post-Traumatic Stress Disorder (PTSD) or a severe active stressor (e.g. child abuse)
- •history of severe psychopathology with an established alternate treatment (e.g. autism spectrum disorder, bipolar disorder, schizophrenia, intellectual disability)
- •general medical condition that may be driving irritability or prevent generalizable physiologic measures.
- •screen positive for an intellectual disability via Wechsler Abbreviated Scale of Intelligence Second Edition (WASI II) estimated Intelligence Quotient (IQ)<70.
研究组 & 干预措施
Parent Management Training
12 sessions of manualized Parent Management Training for irritability developed by the National Institute of Mental Health.
干预措施: Parent Management Training (Behavioral)
结局指标
主要结局
Demonstrate the feasibility of Parent Management Training (PMT) procedures
时间窗: 5 months
The study team will implement a PMT protocol with fidelity and acceptability assessments. The Working Alliance Inventory (WAI) (revised short form) will be used by the clinician and the parent to rate engagement in treatment after each PMT session. There are no established benchmarks for this measure, but it will provide information about the acceptability of the treatment by rating the alliance between the therapist and the parent.
次要结局
- Change in irritability(5 months)