Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.

NCT05824117 | Unknown DMC

• 2 other identifiers: 470569697DRKS00029660
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 6

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.

Conditions

Persistent Delusional Disorder; Acute and Transient Psychotic Disorder, Unspecified; Schizophrenia; Schizoaffective Disorder; Other Nonorganic Psychotic Disorders; Unspecified Nonorganic Psychosis

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  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.

  12 months

Secondary Outcomes (13)

• Length of competitive employment or/and mainstream education

  12 months

• Time to first competitive job/mainstream education

  12 months

• Monthly wages

  12 months

• Educational attainment

  12 months

• Social return on investment (SROI)

  12 months

Study Arms (2)

Intervention Group (TAU+SEE)

EXPERIMENTAL

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.

Other: Individual Placement and Support (IPS)

Control Group (TAU)

NO INTERVENTION

The control condition is treatment as usual (TAU) for adolescents and young adults with early psychosis in the respective recruitment centers for 12 months (including medical review, pharmacological treatment, and psychosocial support: group programs and social counseling to external government-funded vocational programs).

Interventions

Individual Placement and Support (IPS) OTHER

IPS is an evidence-based practice for helping people with severe mental illness to gain and maintain competitive employment or/and mainstream education with nine well defined key principles that can be reliably assessed by the IPS Fidelity Scale for Young Adults. Interventions range from engagement techniques (i.e. motivational interviewing) to individualized education/employment searches and from experience-based educational/employment assessment to benefits in counseling/work incentives planning.

Intervention Group (TAU+SEE)

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Learning disability or mental retardation as well as insufficient German language abilities (\< A2)
• physical or organic handicap that seriously impede work or educational functioning

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (6)

Klinik für Sozialpsychiatrie, Zentrum für Psychiatrie Reichenau

Reichenau, Baden-Wurttemberg, Germany

RECRUITING

Klinik für Psychiatrie und Psychotherapie, LMU Klinikum

München, Bavaria, Germany

RECRUITING

Klinik für Psychiatrie, Psychotherapie und Psychosomatik II, Günzburg

Ulm, Bavaria, Germany

RECRUITING

Klinik für Psychiatrie und Psychotherapie Charité Campus Mitte

Berlin, 10117, Germany

RECRUITING

Klinik für Psychiatrie, Psychotherapie und Psychosomatik Vivantes Klinikum am Urban

Berlin, 10967, Germany

RECRUITING

Klinik für Psychiatrie, Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mental Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andreas Bechdolf, Prof.

  Klinik für Psychiatrie und Psychotherapie, Charite Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Willert, Dr. med.

CONTACT

+4930130226001; anna.willert@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 21, 2023
• Study Start: October 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)