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临床试验/NCT05368701
NCT05368701Unknown不适用

Randomised Controlled Trial of a Smartphone-based App to Reduce Self-harm for CAMHS-treated Adolescents

University of Manchester0 个研究点目标入组 90 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
主要终点
Non-suicidal self-harm

研究概览

简要总结

The aim of the present research is to explore whether a brief, smartphone app-based intervention based on psychological theory can help adolescents to avoid self-harming.

The smartphone app will be piloted in a randomised controlled trial (RCT) with adolescents. 90 adolescents will be recruited and assigned to one of three conditions: (a) intervention group who will complete the smartphone-based VHS app for self-harm (n = 30), (b) control group (n = 30) who will complete paper-and-pencil modified VHS, without the app, and (c) control group who will complete measures via the app but not the VHS (n = 30).

详细描述

Background Self-harm among young people is frequent (McManus et al., 2019) and presents a growing public health concern in England. To date, no robust and comprehensive evidence base exists for effective interventions to prevent self-harm in adolescents (Witt et al., 2021). Therapeutic interventions that are effective among adults, including dialectical behavioural therapy, are only offered to CAMHS patients being diagnosed with a severe mental illness. Young patients with experiences of self-harm and their carers need to access interventions quickly to improve clinical care and reduce future harm. Therefore, novel interventions need to be developed, tested, and evaluated for this vulnerable population.

One such potential intervention is the "volitional help sheet" (VHS). The VHS is a brief psychosocial intervention that significantly reduces thoughts and acts of self-harm in adults admitted to hospital following an initial episode of self-harm (O'Connor et al., 2017). It is based on IF-THEN statements that help people link critical situations to alternative appropriate responses (Armitage, 2008; Gollwitzer, 1993). An example is: "If I feel the urge to self-harm when I want to get relief from a terrible state of mind, then I will do something else instead of self-harming". IF-THEN statements are intended to act as automatic coping responses, especially in cases where people may feel the urge to self-harm.

The VHS has previously been successful in reducing self-harm in people recently admitted to hospital for self-harm (Armitage et al., 2016; O'Connor et al., 2017). Recent data have also demonstrated that a web-based version of the VHS was acceptable among a large representative sample of UK adults with self-harm experiences (Keyworth et al., 2021). However, it is yet to be known whether this intervention is effective and acceptable among adolescents. It is important to conduct this research with experts by experience to create an acceptable and effective intervention, particularly since talking about self-harm does not increase risk of self-harm (Biddle et al., 2013; Blades et al., 2018), and can actually be positive experience for patients (Alexander et al., 2018; Dazzi et al., 2014). This research will co-adapt and pilot the VHS intervention in adolescents presented at CAMHS following an initial episode of self-harm. To maximise engagement with the intervention, we plan to develop this as a smartphone app.

Methods Design Pilot randomised controlled trial. Participants Adolescents who have previously harmed themselves. Setting Data collection will take place online. We will recruit both adolescents that are currently under the care of CAMHS, and those who have been discharged back to community care.

Recruitment and sampling A sample of 90 adolescents that have experienced and index episode of self-harm will be recruited through purposive sampling via Salford CAMHS and 42nd Street.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

The allocation sequence will be concealed from the researcher by using a centralised service (e.g., trial coordination centre) to ensure that selection remains unbiased. Thus, the trial will be double-blind.

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adolescents aged between 12-18, who have been admitted to acute mental health in the past year or diagnosed with functional mental health problems

排除标准

  • •Individuals who cannot give informed consent, or whose parent/guardian cannot give informed consent.
  • •Individuals under the age of 12 years

研究组 & 干预措施

App-based volitional help sheet (VHS) for self-harm

Experimental

A smartphone-based app version of the adapted VHS for self-harm. Participants read a brief statement designed to encourage them to avoid self-harming ("We want you to plan to avoid self-harming"). Participants are presented with ten 'high risk' situations (temptations). By selecting an appropriate situation, 10 appropriate responses (processes of change) are suggested (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to self-harm and identifying ways to overcome those temptations had been shown to help people change their behaviour.

Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.

干预措施: Volitional Help Sheet for self-harm (Behavioral)

App-based pencil-and-paper VHS

Active Comparator

The app will deliver a .pdf file (for printing) worksheet of the VHS for self-harm, with no integration into the app.

Participants read a brief statement designed to encourage them to avoid self-harming ("We want you to plan to avoid self-harming"). Participants are presented with a table with two columns and ten rows. Ten 'high risk' situations (temptations) are presented in the left hand column and 10 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to self-harm and identifying ways to overcome those temptations had been shown to help people change their behaviour.

Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response by drawing a line between the situation and response.

干预措施: Volitional Help Sheet for self-harm (Behavioral)

App with no VHS component

No Intervention

An app with no VHS component that collects questionnaire survey data.

In this control condition, the app only contains the survey questions and links to helplines contained in the other two conditions.

A free text entry box will ask participants to think of important situations where they might self-harm. A second box asks participants to think of alternative plans that they can do instead of self-harming. Participants are not guided to make links between the situations and responses.

结局指标

主要结局

Non-suicidal self-harm

时间窗: 6 months

'Have you ever deliberately harmed yourself in any way but not with the intention of killing yourself? (i.e., self-harm)' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

Suicidal ideation

时间窗: 6 months

'Have you ever seriously thought of taking your life, but not actually attempted to do so?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

Suicide attempt

时间窗: 6 months

'Have you ever made an attempt to take your life, by taking an overdose of tablets or in some other way?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

次要结局

  • Exposure to suicide and mental imagery about death(6 months)
  • Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)(6 months)
  • Habit(6 months)
  • State self-regulation(6 months)
  • Frequencies with which critical situations were encountered and appropriate responses were used(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Leather

Research Associate

University of Manchester

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