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

NCT ID: NCT04916626

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2026-03-31

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.

Detailed Description

The overarching purpose of the OPUS YOUNG trial is to improve the treatment and outcome of first-episode psychosis (FEP) in children and adolescents. We will address this ambition by testing the hypothesis, that Early Intervention Services (EIS) is superior compared to standard care in the treatment of children and adolescents below age 18 years with first-episode psychosis. The hypothesis is based on extrapolation of research showing that EIS is superior to standard care in the treatment of adults with first-episode psychosis with regards to symptom reduction, function improvement, adherence to treatment, lower hospitalization risk, improved recovery, and higher cost-effectiveness. However, no trials have investigated EIS in samples of patients below age 18 years. We will compare the efficacy and cost-effectiveness of EIS to treatment as usual (TAU) in adolescents aged 12-17 years (both inclusive) with first-episode psychosis. We will build on a Danish evidence-based intervention developed for young adults (OPUS) and adjust the concept to meet the specific needs of children and adolescents with early onset psychosis (OPUS YOUNG). The OPUS treatment is a coordinated and integrated manualized multimodal treatment building on three core elements: modified assertive community treatment with a low patient-case manager ratio; psychoeducational family intervention; and social skills training (SST). In OPUS YOUNG we will adjust the OPUS program to fit our younger age group by: 1) intensifying the support for caretakers and relatives including siblings, 2) instead of SST we are introducing social cognition and interaction treatment (SCIT), 3) providing individual cognitive behavioural case management (CBCM) to all participants and cognitive behavioural therapy (CBT) when needed, 4) addressing the specific challenges of psychopharmacologic treatment in adolescents by providing a treatment algorithm, 5) providing intensive supported transition of care (when patients approach transition to adult mental health services), 6) providing individualized school support, and 7) providing integrated prevention and treatment of substance misuse. Based on sample size estimation, we will include a minimum of 284 participants (maximum 304) and randomize them 1:1 to a two-year intervention of OPUS YOUNG versus TAU. We will conduct blinded assessment of treatment effects after 12 months and at treatment endpoint at 24 months. A further follow-up assessment will be performed to evaluate the sustainability of the intervention effects at six months after transition from OPUS YOUNG to TAU. Our primary outcome at treatment endpoint will be social function measured with Personal and Social Performance Scale (PSP). Secondary key outcomes measures are positive and negative symptoms, client satisfaction, and health related quality of life. Further outcomes are the broader psychopathology, cognitive functioning, social cognition, self-efficacy, experience of service, treatment alliance and adherence, the use of pharmacotherapy, school adherence, family burden, siblings' perceived stress, substance misuse, adverse treatment effects, and health economic measures.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OPUS YOUNG

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

Group Type: EXPERIMENTAL

OPUS YOUNG

Intervention Type: 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.

Treatment as Usual, TAU

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: 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.

Interventions

OPUS YOUNG

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Between 12 and 17 years of age (both inclusive) at trial inclusion.

2. 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).

3. Maximum 12 months since first prescription of antipsychotic treatment on the indication psychosis.

4. Speak and understand Danish.

5. 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.

Exclusion Criteria

1. 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).

2. Currently compulsory admission and/or treatment according to Danish legislation

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Anne Katrine Pagsberg

Professor, PhD, senior consultant (child and adolescent psychiatry) and senior researcher.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne K Pagsberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Services in the Capital Region, Denmark

Locations

Mental Health Services in the Capital Region, Denmark

Hellerup, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

OPUS YOUNG

Identifier Type: -

Identifier Source: org_study_id