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临床试验/NCT03120338
NCT03120338已完成不适用

eHealth Services for Child and Adolescent Psychiatry (eCAP): A Trial of the DAWBA as a Rapid Online Assessment Tool

University of Aberdeen2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
2
主要终点
Parent-rated Strengths and Difficulties Questionnaire

研究概览

简要总结

The European Union is funding this randomised trial in Scotland as part of the larger eCAP project (http://www.interreg-npa.eu/projects/funded-projects/project/139/). The need for psychiatric services for children and adolescents is usually greater than the services available. As well as this, in many cases, there is confusion as to which service the child or young person should be referred to. The way children and young people arrive at Child and Adolescent Mental Health Services (CAMHS) may therefore be relatively inefficient and families could suffer as a result of this inefficiency.

The use of a computerised structured questionnaire such as the Development and Well-being Assessment (DAWBA) offers the opportunity for these difficulties to be addressed, for the avoidance of 'inappropriate referrals' and for more rational use of resources. It is usually administered online through a secure internet portal. At the end of the data collection, a computerised summary is generated from the data given by all the informants and a child/adolescent psychiatrist lists the likely diagnosis or diagnoses in a summary of the case and gives his view about the next steps. This is then made available to the referrer. This community-based study aims to establish whether using the DAWBA in this way helps children and young people with mental health problems. The main objectives are to improve their mental health, reduce waiting times, change referral practice, increase satisfaction in services and improve cost effectiveness. The principal outcome measure will be parent-rated Strengths and Difficulties Questionnaire (SDQ) score 6 months after randomisation. Secondary outcome measures will include teacher and child-rated SDQ at 6 months and waiting times to services. The investigators will also record service use data and family out -of -pocket costs. A random sample of young people, family and referrers will be interviewed to explore satisfaction with service.

详细描述

This project will involve 246 participants in each centre (123 intervention, 123 control). Assuming 20% loss to follow-up (i.e. 197 completing) this will give 80% power at 5% significance to detect a moderate effect size of 0.4 in each participating centre. If the investigators assume that the typical SDQ Total Difficulties Score six months after referral is 15 points (the boundary between 'borderline' and 'abnormal' scores), then this would correspond to a difference between the groups of around 2 points which is probably near the lower limit of clinically significant change.

Patient / parent name and telephone number will be supplied to the National Health Service (NHS) Highland research nurse after verbal agreement is given to the referring practitioner that the parent is happy to be contacted to gain formal consent to participate in the project. These details (name and telephone number) will be supplied to enable the research nurse to initially make contact with each participant.

The research nurse will then telephone the parent (contact will be made with the parent first or the young person if aged 16 or over and either the young person or their parent is unwilling for their parent to participate). If the parent agrees, the participant information sheet and consent form will be emailed or posted to the family. Informed consent to participation in the study will be obtained from parents or legal guardians and young people aged 16 & 17, and young people aged 11 to 15 years will be asked for assent. Consent/assent will be requested to cover:

  • Participation in the project;
  • Completion of simple questionnaires at baseline and six months;
  • Provision of relevant contact details (parents, teachers, young people);
  • allowing requests for qualitative interviews;
  • giving researchers access to service use data. The consent form will explain that the project is designed to find out whether doing a detailed mental health assessment before specialist involvement improves the speed and efficiency of service delivery for families (see attached information sheets).

On receipt of the completed consent forms in the post, the NHS research nurse will assign a study number to the family and will contact the university statistics department (in Aberdeen) by email for group allocation. Participants will be assigned at random either to have a DAWBA administered (by parents in every case, by teachers when possible and by young people aged 11 or over) plus usual care, or to receive usual care only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Single Blind

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants will be children, young people between the ages of 2 and 17 inclusive and their families at the first point at which contact with CAMHS is being considered by a health professional.

排除标准

  • Lack of fluency in any of the languages available for DAWBA assessment which could be rated by members of the participating CAMHS services would be the only exclusion criterion.

结局指标

主要结局

Parent-rated Strengths and Difficulties Questionnaire

时间窗: Six months post randomisation

The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire about 3-16 year olds. It exists in several versions to meet the needs of researchers, clinicians and educationalists.

次要结局

  • Service use costs(Six month post randomisation)
  • Waiting times(Six months post randomisation)
  • Child and teacher rated SDQ(Six months post randomisation)
  • Onward referral(Six month post randomisation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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