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临床试验/NCT03481699
NCT03481699已完成不适用

Prevention of Depression and Bullying in Adolescents by Means of an Intervention Based on Implicit Theories of Personality

University of Deusto0 个研究点目标入组 882 人开始时间: 2016年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
882
主要终点
Change from baseline scores of the Revised version of the Peer Experiences Questionnaire (RPEQ; Prinstein, Boergers, & Vernberg, 2001) at 2 weeks, 6 months, and 12 months.

研究概览

简要总结

This study evaluates the efficacy of an intervention based on the Implicit Theories of Personality (ITP) in Spanish adolescents. Half of participants received the ITP intervention, while the other half received an educational intervention.

详细描述

Depression and bullying are two problems arising in childhood and adolescence, which cause severe suffering. Although there are good intervention programs for children and adolescents at risk, the results for universal interventions have generally been poor. The current project will test the efficacy of an Intervention based on the Implicit Theories of Personality (ITP). This procedure has recently been developed at US by David S. Yeager and colleagues, with extraordinary results in the reduction of depression, stress, and aggression. The project includes the following aims: (1) the evaluation of the efficacy of the ITP on depressive symptoms (Study 1) and aggressive behavior (Study 2) in Spanish adolescents; (2) to test whether the intervention changes biological and cognitive variables; (3) to identify whether development and sex moderates the effects of the intervention; and (4) to test whether temperament moderates the effect of the intervention. The study involves the evaluation of the intervention in a sample of around 900 adolescents (12-18 years), randomly allocated to experimental and control condition. It is a field experiment conducted in high schools and involves multiple measures over time (self-reports and parent reports; as well as levels of cortisol, testosterone and DHEA in saliva in a subset -50%- of the participants). In summary, the project aims to respond to the challenge of health and wellness in the population through a randomized controlled trial with multiple sources of measure and from a biopsychosocial perspective. The ITP intervention has the potential to become a universal intervention to help reduce the rates of depression and bullying.

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, Outcomes Assessor)

盲法说明

Allocation was concealed to the participants, researchers -who were in class the assessment days- and teachers.

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

入选标准

  • Informed consent by the adolescents and their parents.
  • To be fluent in Spanish.

排除标准

  • 未提供

研究组 & 干预措施

Incremental theory of personality

Experimental

1 hour behavioral intervention (based on ITP) consisting on several tasks to be completed on paper individually.

干预措施: Incremental theory of personality (Behavioral)

Educational intervention

Other

1 hour educational intervention (about the human brain) consisting on several tasks to be completed on paper individually.

干预措施: Educational Intervention (Other)

结局指标

主要结局

Change from baseline scores of the Revised version of the Peer Experiences Questionnaire (RPEQ; Prinstein, Boergers, & Vernberg, 2001) at 2 weeks, 6 months, and 12 months.

时间窗: Baseline, 2 weeks, 6 months, and 12 months.

Self reported levels of perpetration (9 items) of peer aggression in the school context during the last 6 months (last week in the 1 week follow-up). Each item is scored 1-5 (1 = never; 5 = several times per week), yielding a total between 18 and 90.

Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2012; Gámez-Guadix, Villa-George, & Calvete, 2014) at 2 weeks, 6 months, and 12 months.

时间窗: Baseline, 2 weeks, 6 months, and 12 months.

Self reported levels of perpetration (9 items) of peer cyber aggression during the last 6 months (last week in the 1 week follow-up). Each item is scored 0-3 (0 = never; 3 = five or more times), yielding a total between 0 and 54.

Change from baseline scores of the Center for Epidemiologic Studies Depression scale (CES-D; Radloff, 1977) at 2 weeks, 6 months, and 12 months.

时间窗: Baseline, 2 weeks, 6 months, and 12 months.

Self reported depressive symptoms during the last month (last week in the 1 week follow-up) measured by 20 items scored 0-3 (0 = rarely; 3 = most or almost all the time), yielding a total between 0 and 60.

Change from baseline levels of Cortisol, DHEA and testosterone (in saliva) at 2 weeks, 6 months, and 12 months.

时间窗: Baseline, 2 weeks, 6 months, and 12 months.

A random subset of the participants (n = 546) have provided saliva samples to be assayed for neuroendocrine levels to measure cortisol, DHEA and testosterone. They were directed to transfer saliva from their mouths to a tube. The sample tubes were carefully labelled, and as soon as the session ended, saliva samples were sent to the assay laboratory (Medikosta IMQ Análisis Clínicos) and stored in a freezer at -80°C.

次要结局

未报告次要终点

研究者

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

Esther Calvete

Principal Investigator, Deusto Stress Research Team, University of Deusto

University of Deusto

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