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

• ClinicalTrials.gov Identifier: NCT05824117
• Recruitment Status: Recruiting
• First Posted: April 21, 2023
• Last Update Posted: April 21, 2023
• Sponsor: Charite University, Berlin, Germany
• Information provided by (Responsible Party): Prof. Dr. med. Andreas Bechdolf, Charite University, Berlin, Germany

Tracking Information

• First Submitted Date: March 15, 2023
• First Posted Date: April 21, 2023
• Last Update Posted Date: April 21, 2023
• Actual Study Start Date: October 18, 2022
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 19, 2023)

Primary outcome [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 19, 2023)

• Length of competitive employment or/and mainstream education [ Time Frame: 12 months ]
  Length of competitive employment or/and mainstream education (measured in days)
• Time to first competitive job/mainstream education [ Time Frame: 12 months ]
  Time to first competitive job/mainstream education (measured in days)
• Monthly wages [ Time Frame: 12 months ]
  Monthly wages (measured in Euro)
• Educational attainment [ Time Frame: 12 months ]
  Educational attainment (measured in degrees/qualifications and ECTS points per semester)
• Social return on investment (SROI) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
  Cannabis use is specifically measured using the Daily Sessions, Frequency, Age of Onset and Quantity of Cannabis Use Inventory (DFAQ-CU).
• Relapse [ Time Frame: 12 months ]
  Assessed according to DSM 5 relapse definition criteria.
• Hospitalization [ Time Frame: 12 months ]
  Number of inpatient stays and duration of stays (measured in days) will be assessed.
• Functional impairment [ Time Frame: 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 [ Time Frame: 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.
• Official Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

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

Intervention

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.

Study Arms

• 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.
  Intervention: Other: Individual Placement and Support (IPS)
• 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).

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 19, 2023): 184
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2025
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 35 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Anna Willert, Dr. med.; +4930130226001; anna.willert@charite.de

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT05824117
• Other Study ID Numbers: 470569697; DRKS00029660 ( Registry Identifier: German Clinical Trials Register )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Prof. Dr. med. Andreas Bechdolf, Charite University, Berlin, Germany
• Original Responsible Party: Same as current
• Current Study Sponsor: Charite University, Berlin, Germany
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andreas Bechdolf, Prof.; Klinik für Psychiatrie und Psychotherapie, Charite Universitätsmedizin Berlin

• PRS Account: Charite University, Berlin, Germany
• Verification Date: April 2023