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

Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education (SEE): A Randomized Controlled Trial. Acronym: SEEearly

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizoaffective Disorder; Acute and Transient Psychotic Disorder, Unspecified; Persistent Delusional Disorder; Other Nonorganic Psychotic Disorders; Unspecified Nonorganic Psychosis
• Intervention / Treatment: Other: Individual Placement and Support (IPS)

• Study Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Willert, Dr. med.; Phone Number: +4930130226001; Email: anna.willert@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Klinik für Psychiatrie und Psychotherapie Charité Campus Mitte
    • Contact: Anna Willert, Dr. med.; Email: anna.willert@charite.de
  • Berlin, Germany, 10967
    • Recruiting
    • Klinik für Psychiatrie, Psychotherapie und Psychosomatik Vivantes Klinikum am Urban
    • Contact: Dorothea Jäckel, Dipl. Psych.; Email: dorothea.jaeckel@vivantes.de
  • Hamburg, Germany
    • Recruiting
    • Klinik für Psychiatrie, Universitätsklinikum Hamburg Eppendorf
    • Contact: Anja Rohenkohl, Dr.
  • Baden Württemberg
    • Reichenau, Baden Württemberg, Germany
      • Recruiting
      • Klinik für Sozialpsychiatrie, Zentrum für Psychiatrie Reichenau
      • Contact: Daniel Nischk, Dr.
  • Bayern
    • München, Bayern, Germany
      • Recruiting
      • Klinik für Psychiatrie und Psychotherapie, LMU Klinikum
      • Contact: Oliver Pogarell, Prof.
    • Ulm, Bayern, Germany
      • Recruiting
      • Klinik für Psychiatrie, Psychotherapie und Psychosomatik II, Günzburg
      • Contact: Nicolas Rüsch, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (TAU+SEE); 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); 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.
No Intervention: Control Group (TAU); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of competitive employment or/and mainstream education	Length of competitive employment or/and mainstream education (measured in days)	12 months
Time to first competitive job/mainstream education	Time to first competitive job/mainstream education (measured in days)	12 months
Monthly wages	Monthly wages (measured in Euro)	12 months
Educational attainment	Educational attainment (measured in degrees/qualifications and ECTS points per semester)	12 months
Social return on investment (SROI)	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.	12 months
Subjective quality of life	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.	12 months
Psychopathology	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.	12 months
General substance abuse	General substance abuse (mininum use of 3 times per week per substance) is measured by a modified version of the Addiction Severity Index (ASI).	12 months
Cannabis use	Cannabis use is specifically measured using the Daily Sessions, Frequency, Age of Onset and Quantity of Cannabis Use Inventory (DFAQ-CU).	12 months
Relapse	Assessed according to DSM 5 relapse definition criteria.	12 months
Hospitalization	Number of inpatient stays and duration of stays (measured in days) will be assessed.	12 months
Functional impairment	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).	12 months
Overall functional impairment	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).	12 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Andreas Bechdolf, Prof., Klinik für Psychiatrie und Psychotherapie, Charite Universitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Schizophrenia, Paranoid
• Other Study ID Numbers: 470569697; DRKS00029660 (Registry Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No