Clinical trial NCT03829527: Evaluation of the Treatment Approach ROBIN
Official title: Evaluation of the Treatment Approach ROBIN (Standardized Manual and Smartphone App) for Adolescents With High Risk for Developing a Psychotic Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical High Risk for Psychosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes in at risk symptoms over the different time points
timeFrame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
measure: Changes in comorbid symptoms over the different time points
timeFrame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
measure: Changes in overall global functioning over the different time points
timeFrame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
measure: Changes in the social and occupational functioning over the different time points
timeFrame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
measure: Changes in social functioning over the different time points
timeFrame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
measure: Changes in the quality of life over the different time points: MANSA
timeFrame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
measure: Changes in the self efficacy over the different time points: General Self-efficacy Scale (SWE)
timeFrame: Baseline (0 months); during the treatment (2 months), post-treatment (4 months), follow ups (6, 12, 24 months)
Secondary outcomes:
measure: Satisfaction with the treatment: questionnaire
timeFrame: 4 months (post-treatment)
measure: 7.Satisfaction with the smartphone application Robin Z: feedback form.
timeFrame: 4 months (post-treatment)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich, Department of Child and Adolescent Psychiatry and Psychotherapy
Study officials:
References:
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citation: Traber-Walker N, Gerstenberg M, Metzler S, Joris MR, Karr M, Studer N, Zulauf Logoz M, Roth A, Rossler W, Walitza S, Franscini M. Evaluation of the Combined Treatment Approach "Robin" (Standardized Manual and Smartphone App) for Adolescents at Clinical High Risk for Psychosis. Front Psychiatry. 2019 Jun 6;10:384. doi: 10.3389/fpsyt.2019.00384. eCollection 2019.