ACTRN12618001793202招募中未知
Reducing the impact of bullying victimisation on children's mental health outcomes: A randomised controlled trial evaluating the efficacy of the Cool Kids - Taking Control online program.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 7 Years 至 12 Years（—）
- 性别
- All
入选标准
- •The sample will consist of children aged 7-12 years from across Australia, including from both regional and rural areas. Children will be included in the study if they report being bullied three or more times” in the previous school term (10-weeks) and simultaneously meet the DSM-5 criteria for a diagnosis of an anxiety disorder as their primary, and therefore most interfering, disorder. Participants receiving pharmacological treatment will be included in the study if their medication has been stable for two months prior to the assessment and there are no foreseeable plans for a medication change before commencing treatment.
- •Participants must be willing to provide informed consent (parent consent and child assent) and comply with the requirements of the study will be included. Anxiety diagnosis will be assessed using the ADIS-IV-C/P child and parent versions. This amended form of the ADIS-IV has already been provided to the ethics committee (Ref #: 5201100542).
- •One primary caregiver will need to be involved in the study with their child. They will act in the role as 'coach' and will be responsible for completing measures pertaining to their child (as listed) and will participate in the weekly phone calls with the therapist. The measures are only related to the children in the study and therefore there are no inclusion criteria for parents, other than their willingness to be involved and to play the role as 'coach' over the course of the intervention. Families will be informed that they will need access to a computer or iPad/ tablet in order to access the program, and a telephone.
排除标准
- •We will exclude children if they are exhibiting life threatening suicidal ideation; considered to be at risk of harm due to abuse; have a significant intellectual impairment; have a diagnosis of Autism Spectrum Disorder; have unmanaged psychotic symptoms; or are additionally receiving therapeutic treatment for victimisation and anxiety outside of school. Children excluded from the study will be referred to an appropriate health professional.
- •We will exclude families that do not have access to an electronic device suitable for engaging with the Cool Kids - Taking Control Online program. They will also be excluded if they do not have access to a telephone or cannot commit to weekly 20 minute phone calls over the course of the intervention.
研究者
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