Evaluation of the Treatment Approach ROBIN (Standardized Manual and Smartphone App) for Adolescents With High Risk for Developing a Psychotic Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in at risk symptoms over the different time points
研究概览
简要总结
The prevention of schizophrenia and other psychotic disorders has led researchers to focus on early identification of individuals at Clinical High Risk (CHR) for psychosis and to treat the at-risk symptoms in the pre-psychotic period. Although at-risk symptoms such as attenuated hallucinations or delusions are common in adolescents and associated with a marked reduction in global functioning, the evidence base of effective interventions for adolescents at CHR state and even first-episode psychosis is limited. To fill this gap, the clinicians from the early intervention center in Zurich have developed the treatment approach "Robin" (standardized manual and smartphone App) for adolescents with high risk for developing a psychotic disorder. The treatment approach is based on existing therapy strategies for adolescents with first episode of psychosis and the available recommendations for adults with at-risk symptoms. The evaluation aims firstly to compare the efficacy of "Robin" in 30 CHR adolescents aged 14-18 to an active control group (treatment as usual) from a previous study. Primary outcome measures will be at-risk symptomatology, comorbid diagnosis, functioning, self-efficacy and quality of life. For the prospective intervention condition (16 weekly individual sessions + a minimum 4 family sessions), help-seeking adolescents with CHR for psychosis, aged 14-18, will be recruited over three years. At-risk and comorbid symptoms, functioning, self-efficacy and quality of life are monitored at six time points (baseline, during the treatment period, immediately after intervention, and 6, 12, and 24 months later) and compared to the respective measures of the active control group.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least two self-experienced and self-reported cognitive basic symptoms as assessed by the children-youth version of the Schizophrenia Proneness Interview Child and Youth Version (SPI-CY)
- •and/or 2) at least one attenuated psychotic symptom for psychosis assessed by the Structured Interview for Prodromal Syndromes (SIPS)
排除标准
- •a diagnosis of a psychotic disorder
- •current substance or alcohol dependence
- •insufficient German or English language ability
- •low intellectual abilities with IQ <75
研究组 & 干预措施
Psychotherapy
干预措施: Psychotherapy (Behavioral)
结局指标
主要结局
Changes in at risk symptoms over the different time points
时间窗: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
According to a structured clinical interviews about the clinical high risk state(SIPS, SPI-CY)
Changes in comorbid symptoms over the different time points
时间窗: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
According to a structured clinical interviews about the comorbid symptoms (M.I.N.I. Kid)
Changes in overall global functioning over the different time points
时间窗: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Measured by Global Assessment of Functioning Scale GAF. The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired).
Changes in the social and occupational functioning over the different time points
时间窗: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Measured by the Social and Occupational Functioning Assessment Scale SOFA . The SOFAS is a new scale that differs from the Global Assessment of Functioning (GAF) Scale in that it focuses exclusively on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
Changes in social functioning over the different time points
时间窗: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Measured by theGlobal Functioning: Social (GF: Social) scale The GF: Social scale assesses quantity and quality of peer relationships, level of peer conflict, age-appropriate intimate relationships, and involvement with family members. Emphasis is placed on age-appropriate social contacts and interactions outside of the family, with a particular focus on social withdrawal and isolation. The scales range from 1 till 10 (10 is the highest rating).
Changes in the quality of life over the different time points: MANSA
时间窗: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Self reported level of life quality measured with the Manchester Short Assessment of Quality of Life (MANSA). 16 questions are to be asked every time the instrument is applied. Four of these questions are termed objective and to be answered with yes or no. Twelve questions are strictly subjective. The satisfaction is rated on 7-point rating scales ( = negative extreme, 7 = positive extreme). The twelve items are in the end combined (summed) to get a total score about the life quality.
Changes in the self efficacy over the different time points: General Self-efficacy Scale (SWE)
时间窗: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Self reported level of self efficacy measured with the General Self-efficacy Scale (SWE). The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. The total score can vary between 10 (very low self-efficacy) and 40 (very high self-efficacy).
次要结局
- Satisfaction with the treatment: questionnaire(4 months (post-treatment))
- 7.Satisfaction with the smartphone application Robin Z: feedback form.(4 months (post-treatment))