Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.
- Conditions
- Persistent Delusional DisorderSchizoaffective DisorderAcute and Transient Psychotic Disorder, UnspecifiedSchizophreniaUnspecified Nonorganic PsychosisOther Nonorganic Psychotic Disorders
- Interventions
- Other: Individual Placement and Support (IPS)
- Registration Number
- NCT05824117
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 184
- clinical diagnosis of early psychosis (DSM 5: schizophrenia spectrum and other psychotic disorders (297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) within the last 5 years currently treated as outpatients
- sufficient linguistic and intellectual abilities to take part in the study
- interest in competitive employment or/and mainstream education
- written informed consent
- Learning disability or mental retardation as well as insufficient German language abilities (< A2)
- physical or organic handicap that seriously impede work or educational functioning
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group (TAU+SEE) Individual Placement and Support (IPS) The experimental intervention is treatment as usual (TAU) for adolescents and young adults with early psychosis in the respective recruitment centers for 12 months plus Supported Employment and Education following the Individual Placement and Support model.
- Primary Outcome Measures
Name Time Method Primary outcome 12 months The primary outcome is the binary indicator "Participating steadily for at least 50% of the 12 month follow-up in competitive employment or/and mainstream education". Days in competitive employment or/and mainstream education will be assessed monthly. Competitive employment is defined as jobs that anyone can apply for regardless of disability status. It comprises part and full-time positions, as well as seasonal or temporary positions depending upon the business needs of the employer. Mainstream education is defined in accordance with OECD as educational programs that are certificating or rather degree bearing and open to the general public.
- Secondary Outcome Measures
Name Time Method Monthly wages 12 months Monthly wages (measured in Euro)
Length of competitive employment or/and mainstream education 12 months Length of competitive employment or/and mainstream education (measured in days)
Time to first competitive job/mainstream education 12 months Time to first competitive job/mainstream education (measured in days)
Educational attainment 12 months Educational attainment (measured in degrees/qualifications and ECTS points per semester)
Social return on investment (SROI) 12 months SROI will be computed as the ratio of 'benefits´ to 'total investment´ for each participant and is expressed as percentage. Participants' earnings in both competitive and non-competitive jobs, education, and apprenticeship hereby account as 'benefits´. 'Investments´ are defined as the total vocational program costs and total costs of mental health service per participant.
Subjective quality of life 12 months Subjective quality of life will be measured with the World Health Organization Quality of Life-BREF, a short version of the World Health Organization Quality of Life 100 scale. It's a self-report questionnaire which assesses 4 domains of quality of life: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 4 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely).Higher scores indicate a better quality of life.
Psychopathology 12 months Measured with the Positive and Negative Syndrome Scale (PANSS). The PANSS is a clinical interview rating the patient from 1 to 7 on 30 different symptoms. Ranges for the Positive Scale are 7 (minimum of symptoms) to 49 (maximum of symptoms), for the Negative Scale 7 (minimum of symptoms) to 49 (maximum of symptoms) and for the General Psychopathology Scale 16 (minimum of symptoms) to 112 (maximum of symptoms). Ratings are based on the interview as well as reports of family member and/or primary care workers. The interviewer must be trained to a standardized level of reliability.
General substance abuse 12 months General substance abuse (mininum use of 3 times per week per substance) is measured by a modified version of the Addiction Severity Index (ASI).
Cannabis use 12 months Cannabis use is specifically measured using the Daily Sessions, Frequency, Age of Onset and Quantity of Cannabis Use Inventory (DFAQ-CU).
Relapse 12 months Assessed according to DSM 5 relapse definition criteria.
Hospitalization 12 months Number of inpatient stays and duration of stays (measured in days) will be assessed.
Functional impairment 12 months Functional impairment with regard to occupational activity and participation will be assessed using a short version of the International Classification of Functioning, Disability, and Health (Mini-ICF-APP) instrument. The instruments consists of 13 capacity dimensions: adherence to regulations, planning and structuring of tasks, flexibility, applying expertise, capacity to judge and decide, endurance, assertiveness, contacts with others, teamwork capacity, self-care, mobility, proactivity and familiar and intimate relationships. Each dimension is rated from 0 (no impairment) to 4 (full impairment).
Overall functional impairment 12 months Overall level of functioning will be assessed using the Global Assessment of Functioning (GAF) scale. The GAF is a numeric scale to rate social, occupational and psychological functioning of an individual. Scores range from 1 (severely impaired) to 100 (extremely high functioning).
Trial Locations
- Locations (6)
Klinik für Psychiatrie und Psychotherapie Charité Campus Mitte
🇩🇪Berlin, Germany
Klinik für Psychiatrie, Psychotherapie und Psychosomatik II, Günzburg
🇩🇪Ulm, Bayern, Germany
Klinik für Psychiatrie und Psychotherapie, LMU Klinikum
🇩🇪München, Bayern, Germany
Klinik für Psychiatrie, Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Klinik für Sozialpsychiatrie, Zentrum für Psychiatrie Reichenau
🇩🇪Reichenau, Baden Württemberg, Germany
Klinik für Psychiatrie, Psychotherapie und Psychosomatik Vivantes Klinikum am Urban
🇩🇪Berlin, Germany