Evaluation of the Treatment Approach ROBIN
- Conditions
- Clinical High Risk for Psychosis
- Interventions
- Behavioral: Psychotherapy
- Registration Number
- NCT03829527
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
-
- 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)
- a diagnosis of a psychotic disorder
- current substance or alcohol dependence
- insufficient German or English language ability
- low intellectual abilities with IQ <75
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Psychotherapy Psychotherapy -
- Primary Outcome Measures
Name Time Method Changes in at risk symptoms over the different time points 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 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 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 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 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 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) 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).
- Secondary Outcome Measures
Name Time Method Satisfaction with the treatment: questionnaire 4 months (post-treatment) Subjective satisfaction with the therapy measured by a german questionnaire about the treatment satisfaction. The questionnaire is called "Fragebogens zur Beurteilung der Behandlung". Translation ins english is: Questionnaire about the treatment satisfaction.
It contains 20 different questions about the treatment satisfaction on a rating scale from 0 till 5. So, the total score is between 0 (no treatment satisfaction) and 100 (highest treatment satisfaction).7.Satisfaction with the smartphone application Robin Z: feedback form. 4 months (post-treatment) Subjective satisfaction with the smartphone application measured by questionnaire regarding usability and subjective satisfaction with the app. The questionnaire was created by the study team, no standardized measurement tool is used. The questionnaire is a feedback form, that gives the study team qualitative information about the usability and satisfaction with the smartphone application. The only quantitive information that is gained from this questionnaire is the overall satisfaction with the application. The subjects can give a rating from 1 (lowest satisfaction) till 6 (highest satisfaction).
Trial Locations
- Locations (1)
University of Zurich, Department of Child and Adolescent Psychiatry and Psychotherapy
🇨🇭Zurich, Switzerland