The OPUS YOUNG Trial. Early Intervention Versus Treatment as Usual for Adolescents With First-episode Psychosis

NCT04916626 | Active Not Recruiting

• 1 other identifier: OPUS YOUNG
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

The OPUS YOUNG (OY) study investigates the efficacy of early intervention service versus treatment as usual (TAU) for adolescents aged 12-17 years with a first-episode psychosis. In Denmark, the yearly incidence of schizophrenia in youth below the age of 18 years has increased from 137 in 2000 to 477 in 2016. Outcomes in people with schizophrenia spectrum disorders are suboptimal with low quality of life, low rates of recovery, substance misuse, higher rates of suicide, violence and legal problems, low educational and vocational attainment, and a significantly reduced life-expectancy of 15-20 year. Schizophrenia imply a large burden of disease with severe impact on patients, their families, the service system and a large economic societal burden. The investigators will include 290 participants age 12-17 years with an early onset psychosis within the following diagnostic classes: schizophrenia spectrum, psychotic depression or drug-induced psychosis. The design is an independent, investigator initiated, pragmatic, randomized clinical trial, with blinded outcome assessment. Participants are randomized 1:1 to OY or TAU. Participants in OY are offered 2 years of specialized intervention (OY) regardless of age, while participants in TAU are switched to adult psychiatry at the age of 18 years. OY builds on the Danish evidenced based intervention for young adults, OPUS, adjusted to meet the specific needs of adolescents: intensified support for caretakers and relatives including siblings; social cognition and interaction treatment; and individual cognitive behavioral case management. OY addresses the specific challenges of psychopharmacologic treatment in youth; supported transition to adult care after OY; school or educational support; and prevention and treatment of substance misuse. The primary endpoint is improved functioning in daily and social life after 24 months. Secondary outcome measures are psychopathology, quality of life, family stress, and retention in treatment and school/employment, and healthcare consumption. The clinical and societal perspective of a large scale implementation is improved prevention of the negative consequences of early-onset psychosis and a reduced burden of severe mental illness.

Conditions

Schizophrenia; Schizotypal Disorder; Delusional Disorder; Acute and Transient Psychotic Disorder, Unspecified; Schizoaffective Disorder; Non-Organic Psychosis; Depression Severe; Substance Induced Psychoses

Keywords

Specialized early intervention; Early onset psychosis; Children and adolescents; Recovery and resilience; Cost-effectiveness; Cross-sectional

Outcome Measures

Primary Outcomes (1)

• Personal and Social Performance Scale (PSP)

  Change in the global score of social function, measured with Personal and Social Performance Scale (PSP). PSP provides a global score on a scale from 1-100, with lower scores indicating lower social functioning. The global score is based on scores on four subdomains (1. Socially useful activities, 2. Personal and social relationships, 3. Self-care, and 4. Disturbing and aggressive behaviour), rated on a 6-point Likert scale (1=absent to 6=very severe). The scoring of PSP is based on all available information and concerns the patient's daily level of functioning in the family, in school, and during leisure time during the past month. Higher global values mean better social function. Researchers will interview the participants prior to the scoring of PSP using a semi structured interview guide suitable for children and adolescents, developed by the OPUS YOUNG research team.

  Last month at baseline (from enrollment), at month 12, at month 24 and at month 30

Secondary Outcomes (5)

• Severity of psychotic symptom dimension, SAPS

  Last month at baseline (from enrollment), at month 12, at month 24 and at month 30

• Severity of Negative symptom dimension, SANS

  Last month at baseline (from enrollment), at month 12, at month 24 and at month 30

• Severity of disorganized symptom dimension

  Last month at baseline (from enrollment), at month 12, at month 24 and at month 30

• Client satisfaction questionnaire, CSQ

  Present time at month 12 and at month 24.

• Quality of life, - Health Related Quality of Life Questionnaire for Children and Young People and their Parents, KIDSCREEN-10

  Last week at baseline (from enrollment), at month 12, at month 24 and at month 30

Other Outcomes (49)

• Registration of multiaxial diagnostics, Schedule for affective disorders and schizophrenia for school-aged children (6-18 years) (K-SADS-PL), present and lifetime

  Present and lifetime at baseline (from enrollment), at month 12 and at month 24

• Hallucinations, Experiences of thought disorder and Delusions, Schedules for Clinical Assessment in Neuropsychiatry (SCAN 2.1)

  Present and lifetime at baseline (from enrollment), at month 12 and at month 24

• Manic symptoms, (YMRS)

  Last 2 days at baseline (from enrollment), at month 12, at month 24 and at month 30

Study Arms (2)

OPUS YOUNG

EXPERIMENTAL

OPUS YOUNG is a two years out-patients specialized early intervention services for children and adolescents with a first episode psychosis. OPUS YOUNG is characterized by a multidisciplinary team, assertive outreach, tailored cognitive behavioral case management, and low caseload and insensitive psychoeducational family involvement

Behavioral: OPUS YOUNG

Treatment as Usual, TAU

ACTIVE COMPARATOR

Treatment as Usual will be carried out by outpatient clinic in Child and Adolescent Mental Health Services (CAMHS). Patients will be offered treatment following national Danish guidelines and local guidelines, provided by a multidisciplinary team, case-management (no defined upper-case load), family support. In general, office visits take place in outpatient clinics.

Behavioral: Treatment as Usual

Interventions

OPUS YOUNG BEHAVIORAL

OPUS YOUNG is a two year out-patient specialized early intervention service for children and adolescents with a first episode psychosis. The OPUS YOUNG treatment consists of the following elements: modified assertive community treatment, low patients to case manager ratio, cognitive-behavioural case management (CBCM), psycho-educational family treatment including multiple family groups(MFG) and psychoeducational siblings groups, Social Cognition and Interaction Training (SCIT), possible individual Cognitive Behavioural Therapy (CBT) in addition to CBCM, and manual based psychopharmacologic treatment. Additional, special transition support, individual school/employment support, and prevention and treatment of substance abuse.

OPUS YOUNG

Treatment as Usual BEHAVIORAL

The patients allocated to TAU will be offered non-manualized treatment following national Danish guidelines and local guidelines. Treatment is provided by a multidisciplinary team and consists of case-management (no defined upper case load), family support and psychoeducation, in addition to psychopharmacological treatment. In some cases, social skills training and CBT may be offered. In general, office visits take place in outpatient clinics.

Treatment as Usual, TAU

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• First-episode psychosis within F2 spectrum (F20 schizophrenia, F21 Schizotypal disorder, F22 delusional disorder, F23 acute and transient psychotic disorders, F25 schizoaffective disorders, F28/29 other or un-specified non-organic psychosis) or depression with psychotic symptoms (F32.3, F33.3) or substance-induced psychosis (F1X.5) according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10).
• Maximum 12 months since first prescription of antipsychotic treatment on the indication psychosis.
• Speak and understand Danish.
• Written informed consent from parents or legal caretakers. Participants who reach age 18 years during the trial will be asked to give personal written informed consent to continue their study participation.

You may not qualify if:

• A diagnosis of mental retardation of at least moderate severity defined as an intelligence quotient (IQ)of 49 or below (F71, F72, F73 according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10).
• Currently compulsory admission and/or treatment according to Danish legislation

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

Mental Health Services in the Capital Region, Denmark

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Schizophrenia; Schizotypal Personality Disorder; Schizophrenia, Paranoid; Psychotic Disorders; Mental Disorders; Psychoses, Substance-Induced

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Personality Disorders; Poisoning; Chemically-Induced Disorders; Substance-Related Disorders

Study Officials

• Anne K Pagsberg, PhD

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are masked. The statistical evaluation of the effects of OY versus TAU will be carried out by researchers who will be masked for the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, senior consultant (child and adolescent psychiatry) and senior researcher.

Model Details: The randomized clinical trial is a parallel, two-arm, superiority trial comparing OPUS YOUNG with TAU for children and adolescents aged 12 - 17 years with a first episode psychosis

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: June 7, 2021
• Study Start: May 6, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)