Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The change of NSSI behavior of the participants.
研究概览
简要总结
In this proposed study, Text messages are used to intervene in the NSSI behavior of adolescents, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of adolescents' NSSI behavior is discussed.
详细描述
In this proposed study, the investigators will evaluate the effect of text message intervention on Nonsuicidal self-injury behavior in adolescents. The study will recruit 110 adolescents with Nonsuicidal self-injury behavior in outpatient and ward, then all the participants will be randomized to the intervention group (55 cases) or the control group 55 cases) for an 8-week clinic trial. Clinical efficacy and safety assessment will be done at baseline, the fourth week, and the eighth week. The specific aims are to evaluate the effect of text message intervention on NSSI in adolescents are on 1) Tendency and frequency of Nonsuicidal self-injury behavior; 2) Level of negative emotion such as depression, anxiety, and hopelessness 3) The use of emotion regulation strategies and coping styles. A semi-structured quantitative interview will be conducted among adolescents from the SMS group to get the attitude and experiences feedback about the text message.
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
- None
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 10-19 years old.
- •Meet the diagnostic criteria of NSSI behavior recommended by DSM-
- •The adolescents who have mobile phone, and have the ability to send or receive text messages.
- •Adolescents and guardians agreed to participate and signed the informed consent form
排除标准
- •Adolescents with severe somatic diseases who cannot complete the study.
- •Adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study.
- •The adolescents who do not have a mobile phone.
研究组 & 干预措施
intervention group
Text messages will be sent to the subjects through the investigator, including giving popularization of psychiatric knowledge, coping skills, emotional regulation strategies, and brief care. Two or three times a week for two months.
干预措施: SMS intervention (Other)
control group
Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up.
结局指标
主要结局
The change of NSSI behavior of the participants.
时间窗: At baseline, the fourth week, the eighth week
NSSI behavior will be measured by Nonsuicidal self-injury Questionnaire which contains several items designed by investigators. The questionnaire is mainly used to measure the frequency of NSSI among adolescents.
次要结局
- The change of depression level.(At baseline, the fourth week, the eighth week)
- The change of hopelessness.(At baseline, the fourth week, the eighth week)
- The change of emotion regulation strategies.(At baseline, the fourth week, the eighth week)
- The change of life events stress.(At baseline, the fourth week, the eighth week)
- The change of anxiety level.(At baseline, the fourth week, the eighth week)
- The change of coping styles.(At baseline, the fourth week, the eighth week)
研究者
Jian-Jun Ou
Principal Investigator
Central South University