Evaluation of the Treatment Approach ROBIN

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Treatment Approach ROBIN (Standardized Manual and Smartphone App) for Adolescents With High Risk for Developing a Psychotic Disorder

Conditions
-----------------
Clinical High Risk for Psychosis

Intervention / Treatment
-----------------
* Behavioral: Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) 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) Exclusion Criteria: a diagnosis of a psychotic disorder current substance or alcohol dependence insufficient German or English language ability low intellectual abilities with IQ <75

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychotherapy<br> | Behavioral: Psychotherapy<br>* Psychological intervention combining a standardized treatment manual with a smartphone application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in at risk symptoms over the different time points | According to a structured clinical interviews about the clinical high risk state(SIPS, SPI-CY) | Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months) | 
| Changes in comorbid symptoms over the different time points | According to a structured clinical interviews about the comorbid symptoms (M.I.N.I. Kid) | Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months) | 
| Changes in overall global functioning over the different time points | 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). | Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months) | 
| Changes in the social and occupational functioning over the different time points | 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. | Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months) | 
| Changes in social functioning over the different time points | 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). | Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months) | 
| Changes in the quality of life over the different time points: MANSA | 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. | Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months) | 
| Changes in the self efficacy over the different time points: General Self-efficacy Scale (SWE) | 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). | Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the treatment: questionnaire | 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). | 4 months (post-treatment) | 
| 7.Satisfaction with the smartphone application Robin Z: feedback form. | 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). | 4 months (post-treatment) |