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

Primary Purpose

Persistent Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Individual Placement and Support (IPS)
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Delusional Disorder

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Sozialpsychiatrie, Zentrum für Psychiatrie ReichenauRecruiting
  • Klinik für Psychiatrie und Psychotherapie, LMU KlinikumRecruiting
  • Klinik für Psychiatrie, Psychotherapie und Psychosomatik II, GünzburgRecruiting
  • Klinik für Psychiatrie und Psychotherapie Charité Campus MitteRecruiting
  • Klinik für Psychiatrie, Psychotherapie und Psychosomatik Vivantes Klinikum am UrbanRecruiting
  • Klinik für Psychiatrie, Universitätsklinikum Hamburg EppendorfRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group (TAU+SEE)

Control Group (TAU)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2023
Last Updated
April 19, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05824117
Brief Title
Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education.
Acronym
SEEearly
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizophrenia, Schizoaffective Disorder, Other Nonorganic Psychotic Disorders, Unspecified Nonorganic Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (TAU+SEE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (TAU)
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Individual Placement and Support (IPS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary outcome
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Length of competitive employment or/and mainstream education
Description
Length of competitive employment or/and mainstream education (measured in days)
Time Frame
12 months
Title
Time to first competitive job/mainstream education
Description
Time to first competitive job/mainstream education (measured in days)
Time Frame
12 months
Title
Monthly wages
Description
Monthly wages (measured in Euro)
Time Frame
12 months
Title
Educational attainment
Description
Educational attainment (measured in degrees/qualifications and ECTS points per semester)
Time Frame
12 months
Title
Social return on investment (SROI)
Description
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.
Time Frame
12 months
Title
Subjective quality of life
Description
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.
Time Frame
12 months
Title
Psychopathology
Description
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.
Time Frame
12 months
Title
General substance abuse
Description
General substance abuse (mininum use of 3 times per week per substance) is measured by a modified version of the Addiction Severity Index (ASI).
Time Frame
12 months
Title
Cannabis use
Description
Cannabis use is specifically measured using the Daily Sessions, Frequency, Age of Onset and Quantity of Cannabis Use Inventory (DFAQ-CU).
Time Frame
12 months
Title
Relapse
Description
Assessed according to DSM 5 relapse definition criteria.
Time Frame
12 months
Title
Hospitalization
Description
Number of inpatient stays and duration of stays (measured in days) will be assessed.
Time Frame
12 months
Title
Functional impairment
Description
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).
Time Frame
12 months
Title
Overall functional impairment
Description
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).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Willert, Dr. med.
Phone
+4930130226001
Email
anna.willert@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Bechdolf, Prof.
Organizational Affiliation
Klinik für Psychiatrie und Psychotherapie, Charite Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Sozialpsychiatrie, Zentrum für Psychiatrie Reichenau
City
Reichenau
State/Province
Baden Württemberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Nischk, Dr.
Facility Name
Klinik für Psychiatrie und Psychotherapie, LMU Klinikum
City
München
State/Province
Bayern
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Pogarell, Prof.
Facility Name
Klinik für Psychiatrie, Psychotherapie und Psychosomatik II, Günzburg
City
Ulm
State/Province
Bayern
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Rüsch, Prof.
Facility Name
Klinik für Psychiatrie und Psychotherapie Charité Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Willert, Dr. med.
Email
anna.willert@charite.de
Facility Name
Klinik für Psychiatrie, Psychotherapie und Psychosomatik Vivantes Klinikum am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothea Jäckel, Dipl. Psych.
Email
dorothea.jaeckel@vivantes.de
Facility Name
Klinik für Psychiatrie, Universitätsklinikum Hamburg Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Rohenkohl, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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