Evaluation of the Treatment Approach ROBIN

NCT ID: NCT03829527

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2022-09-30

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.

Conditions

Clinical High Risk for Psychosis

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Psychotherapy

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

Psychological intervention combining a standardized treatment manual with a smartphone application

Interventions

Psychotherapy

Psychological intervention combining a standardized treatment manual with a smartphone application

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Zurich, Department of Child and Adolescent Psychiatry and Psychotherapy

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

Maurizia Frascini, Dr.med.

Role: primary

Franscini Maurizia <Maurizia.Franscini@puk.zh.ch>

41 43 499 26 26

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Reference Type: DERIVED

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Other Identifiers

ETRo2017-00012

Identifier Type: -

Identifier Source: org_study_id