School-based Treatment of Social Anxiety: A Randomized and Controlled Study Using Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Clinical severity of SAD symptoms
研究概览
简要总结
The goal of this randomized controlled trial is to find out whether the brief, 10-session Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD) is more effective than standard counseling (SC) to treat Social Anxiety Disorder (SAD) among 12 to 17-year-old adolescents with SAD.
Potential participants for the study are identified from school health and well-being services (SHWS). The DOCT-SAD is delivered by method-trained school psychologists working in the SHWS. SC will be provided by non-method-trained SHWS professionals (i.e. school nurses, social workers or school psychologists) according to their routine counselling practice.
The main research questions of the study are:
- Is DOCT-SAD more effective than SC for alleviating symptoms of social anxiety?
- Is DOCT-SAD more effective than SC to produce diagnostic remission from primary SAD and alleviating symptom severity associated with SAD?
- Is DOCT-SAD more effective than SC for alleviating co-occurring depressive symptoms, interference in daily functioning due to worry or fears, and for increasing general well-being, positive mental health, and for improving the quality of life among adolescents with SAD?
Researchers will compare DOCT-SAD with SC to see if DOCT-SAD is effective in the treatment of SAD in adolescents.
Participants will:
- be treated either with DOCT-SAD or SC for 10 weeks.
- be followed up and assessed clinically at six-month and twelve-month follow-up points.
详细描述
Aim:
The aim of this randomized controlled trial is to investigate whether a brief, 10-session intervention, the Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD; in Finnish Tosi minä -treeni) is more effective than standard counseling (SC) for alleviating symptoms of social anxiety and to treat Social Anxiety Disorder (SAD) among adolescents identified from School Health and Well-being Services (SHWS) of mandatory public schools.
Participants:
Participants comprise of students in the grades 7-9 of the public secondary schools, and students in the 1st or 2nd year-course of public high schools and vocational schools in the Tampere area of Finland. They are aged from 12 to 17 years. All participants will present with primary SAD according to DSM-5 criteria. In total, 156 students will be recruited.
Procedure:
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 13-17 years
- •diagnosis of DSM-5 SAD (Social Anxiety Disorder)
- •SAD is the primary mental health disorder
- •motivation of the adolescent and parent to attend DOCT-SAD / SC as described in the study protocol
- •good command of the Finnish language.
排除标准
- •intellectual deficit
- •presence of primary autism spectrum disorder
- •marked psychotic symptoms or psyhotic disorder
- •severe eating disorder, depression or primary other anxiety disorder requiring acute treatment which need to be prioritized above treatment of social anxiety
- •acute suicidality or suicide risk
- •substance use or substance use disorder requiring child protection measures
- •presence of contextual/environmental risk factors in the participants surroundings which require child protection measures
研究组 & 干预措施
Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD)
Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD) is a ten-session, combined group/individual intervention program for treating social anxiety and social anxiety disorder in adolescents. It consists of four individual and six group sessions delivered during a ten-week period. The number of adolescents in each DOCT-SAD group varies between four and six. One or both parents attend two of the individual DOCT-SAD sessions.
干预措施: DOCT-SAD (Behavioral)
Standard Counseling (SC)
Standard Counseling (SC) is an intervention consisting of counseling sessions delivered by a school health and welfare (SHWS) professional (i.e., school nurse, school social worker, or school psychologist) to support a student with social anxiety. The defined length of intervention is ten weeks. In SC, routine professional working methods and procedures available to the SHWS professional delivering the intervention are used.
干预措施: SC (Behavioral)
结局指标
主要结局
Clinical severity of SAD symptoms
时间窗: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up
Change in the clinical severity of SAD symptoms assessed with the CSR scale of the ADIS-5 interview schedule
Self-reported social anxiety symptoms
时间窗: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up point, and to 12-month follow-up point
Change in self-reported social anxiety symptoms assessed with the Social Phobia Inventory (SPIN)
Diagnostic status of SAD
时间窗: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up point, and to 12-month follow-up point
Change in the diagnostic status of SAD according DSM-5 criteria, assessed with ADIS-5 interview schedule
次要结局
- Self-reported safety behaviours associated with SAD(From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up)
- Parent-reported life interference due to adolescent's fears and worries(From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up)
- Self-reported life interference due to fears and worries(From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up)
- Self-reported general well-being(From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up)
- Self-reported depressive symptoms(From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up)
- Self-reported positive mental health(From treatment startpoint to the end of the follow-up period (12 months))
- Self-reported quality of life(From treatment startpoint to the end of the follow-up period (12 months))
研究者
Klaus Ranta
Associate Professor
Tampere University