Intellectual DisabilityNCT04728074
Effects of Vocational Rehabilitation Group Intervention on Motivation and Occupational Self-Awareness in Individuals With Intellectual Disabilities
A study testing The Entering Employment and Sustaining Work Program and vocational rehabilitation in people with Intellectual Disability, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study is an intervention study that investigates the effects of a group-based approach to motivation and occupational self-awareness of individuals with intellectual disability (ID). The intervention method was developed by following the intervention mapping method. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- The Entering Employment and Sustaining Work Program and vocational rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2020to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being between the ages of 18 and 65,
- Not being currently working,
- Having formal intellectual disability diagnosis,
- Having scored 23 points or less from the Mini Mental State Examination,
- Being able to understand basic Turkish language and 6) Volunteering to participate in the study
Who cannot join
- Having severe communication problems specifically in self-expression,
- Not being able to continue participating in the study for the projected study duration,
- Not permitted to participate by legal guardian.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vocational Rehabilitation Group Intervention on Motivation and Occupational Self-Awareness in Individuals With Intellectual Disabilities: A Single-Blind, Randomized Control Study
This study is an intervention study that investigates the effects of a group-based approach to motivation and occupational self-awareness of individuals with intellectual disability (ID).
The intervention method was developed by following the intervention mapping method.
Read more
An 8 weeks group intervention (twice a week) was applied to individuals with ID which includes; Introduction to intervention and meeting with other group members self-awareness training occupational self-awareness taking responsibility group work and labor division problem identification problem-solving
The entire program was structured and guided by the prepared manual (available upon request from the authors). The manual was prepared by the authors of this study to ensure consistency between different sessions and groups. All sessions were diffusively explained in the manual as well as the individual session booklets. The supervisors were able to follow the structure of the sessions from those booklets. Additionally, there were visual materials for each session as in; presentations, graphics, and photographs. The program supervisors (therapists) met once every week to discuss the progress, participation, and overall status of each participant.
Homework assignments were utilized to facilitate learning. Families were not included directly in the group sessions, however were informed about the homework assignments. Homework assignments consisted of very basic mental practice and reenactment regarding the session's topic and concepts. Families were also included in the final week's sessions since graduation certificates were handed out during these sessions and also small celebrations were carried out.
- Conditions
- Intellectual Disability
- Being tested
- The Entering Employment and Sustaining Work Program, vocational rehabilitation
- Keywords
- self awareness, occupational therapy, vocational rehabilitation, intellectual disability, motivation
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Entering Employment and Sustaining Work ProgramOther
Also called Occupational therapy - vocational rehabilitation
A structured, motivation and self-awareness based group intervention
vocational rehabilitationOther
An individual based, focused on desired job or occupation, face-to-face intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The ENtering Employment and SUstaining Work (ENESUW) program consists of 6 main topics which are; "self-awareness", "occupational self-awareness", "taking responsibility", "teamwork and labor division", "problem identification" and "problem solving". The entire program adopts a very plain and easy to understand method of information transmission in order to facilitate lossless comprehension and strengthen the trust relationship between the therapists and the participants.
The ENESUW program took 8 weeks in total with twice weekly sessions, making up a total of 16 structured group sessions. The group format enabled the participants to learn through meaningful peer interactions and group activities which were supportive of the main learning goals (i.e. group work, labor division and taking responsibility) of the program. The twice weekly sessions were 45 minutes long in order to keep the participants attentive and active throughout the program. Receives: Other: The Entering Employment and Sustaining Work Program; Other: vocational rehabilitation |
| control | Active comparator | The control group also consisted of individuals with ID. They received face to face, individual vocational based occupational therapy approaches, which were twice a week for 8 weeks (approximately 40-45 minutes) Receives: Other: vocational rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Self-Assessment version 2.2 (OSA 2.2)
Occupational Self-Assessment (OSA) is a comprehensive assessment which was designed to collect information regarding the individuals' occupational self-awareness. The OSA is an entirely self-reported tool regarding occupational competence and value. The 21 item OSA evaluates skills (item 1-11), habituation (12-16) and volition (17-21). Each item contains two sets of 4-point Likert scales, the first scale is about the individuals' performance in various activities (1- I have a lot of problem doing this, 2 - I have some difficult doing this, 3 - I do this well, and 4 points = I do this extremely well) and the second scale is about the values of those activities for the individual 1 - This is not important to me, 2 - This is important to me, 3 -This is more important to me; and 4- This is most important to me)
Measured: Change from Baseline and to the 2 months
Objective Achievement Motivation Test - OLMT):
The OLMT is a test which is used for Job \& Career replacement and academic testing by assessing examinee's achievement motivation under different circumstances. The OLMT consists of 3 subtests, these 3 subtests include a particular stimulus that motivates respondent's performance: the task itself, setting own goals, and from competition. The test also evaluates the match or mismatch between the set goals and actual performance (aspiration level). For testing; the respondent requires to move a prescribed route cell by cell by pressing two buttons (red and green) repeatedly in ten seconds. For the aspiration level, the respondent sets a goal for the test and tries to accomplish the set goal by performing the first test. The final part the respondent competes against a virtual opponent whose speed is slightly above the mean of the first two tests of the respondent. The scoring of the test is performed by a special software
Measured: Change from Baseline and to the 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start6 Feb 2020
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind, randomized control study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University
- Responsible party
- Principal investigator, Orkun Tahir Aran, Hacettepe University
- Investigators
- Hülya Kayıhan, Prof, Study chair, Occupational Therapy, head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728074
- Sponsor's protocol ID
- 2020/34-18
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kocman A, Weber G. Job Satisfaction, Quality of Work Life and Work Motivation in Employees with Intellectual Disability: A Systematic Review. J Appl Res Intellect Disabil. 2018 Jan;31(1):1-22. doi: 10.1111/jar.12319. Epub 2016 Dec 21.
PubMed 28000421Wehman P, Chan F, Ditchman N, Kang HJ. Effect of supported employment on vocational rehabilitation outcomes of transition-age youth with intellectual and developmental disabilities: a case control study. Intellect Dev Disabil. 2014 Aug;52(4):296-310. doi: 10.1352/1934-9556-52.4.296.
PubMed 25061773
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vocational Rehabilitation Group Intervention on Motivation and Occupational Self-Awareness in Individuals With Intellectual Disabilities: A Single-Blind, Randomized Control Study
- ClinicalTrials.gov ID
- NCT04728074
- Acronym / sponsor ID
- 2020/34-18
- Conditions
- Intellectual Disability
- Keywords
- self awareness, occupational therapy, vocational rehabilitation, intellectual disability, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Biruni University
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an intervention study that investigates the effects of a group-based approach to motivation and occupational self-awareness of individuals with intellectual disability (ID).
The intervention method was developed by following the intervention mapping method.
An 8 weeks group intervention (twice a week) was applied to individuals with ID which includes; Introduction to intervention and meeting with other group members self-awareness training occupational self-awareness taking responsibility group work and labor division problem identification problem-solving
The entire program was structured and guided by the prepared manual (available upon request from the authors). The manual was prepared by the authors of this study to ensure consistency between different sessions and groups. All sessions were diffusively explained in the manual as well as the individual session booklets. The supervisors were able to follow the structure of the sessions from those booklets. Additionally, there were visual materials for each session as in; presentations, graphics, and photographs. The program supervisors (therapists) met once every week to discuss the progress, participation, and overall status of each participant.
Homework assignments were utilized to facilitate learning. Families were not included directly in the group sessions, however were informed about the homework assignments. Homework assignments consisted of very basic mental practice and reenactment regarding the session's topic and concepts. Families were also included in the final week's sessions since graduation certificates were handed out during these sessions and also small celebrations were carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind, randomized control study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: The Entering Employment and Sustaining Work Program, Other: vocational rehabilitationThe ENtering Employment and SUstaining Work (ENESUW) program consists of 6 main topics which are; "self-awareness", "occupational self-awareness", "taking responsibility", "teamwork and labor division", "problem identification" and "problem solving". The entire program adopts a very plain and easy to understand method of information transmission in order to facilitate lossless comprehension and strengthen the trust relationship between the therapists and the participants. The ENESUW program took 8 weeks in total with twice weekly sessions, making up a total of 16 structured group sessions. The group format enabled the participants to learn through meaningful peer interactions and group activities which were supportive of the main learning goals (i.e. group work, labor division and taking responsibility) of the program. The twice weekly sessions were 45 minutes long in order to keep the participants attentive and active throughout the program. |
| control | Active comparator | Other: vocational rehabilitationThe control group also consisted of individuals with ID. They received face to face, individual vocational based occupational therapy approaches, which were twice a week for 8 weeks (approximately 40-45 minutes) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being between the ages of 18 and 65,
- Not being currently working,
- Having formal intellectual disability diagnosis,
- Having scored 23 points or less from the Mini Mental State Examination,
- Being able to understand basic Turkish language and 6) Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Having severe communication problems specifically in self-expression,
- Not being able to continue participating in the study for the projected study duration,
- Not permitted to participate by legal guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Entering Employment and Sustaining Work ProgramAlso: Occupational therapy - vocational rehabilitationA structured, motivation and self-awareness based group intervention | Other | Intervention |
| vocational rehabilitationAn individual based, focused on desired job or occupation, face-to-face intervention | Other | Intervention, control |
Primary outcome
Occupational Self-Assessment version 2.2 (OSA 2.2)
Time frame: Change from Baseline and to the 2 months
Occupational Self-Assessment (OSA) is a comprehensive assessment which was designed to collect information regarding the individuals' occupational self-awareness. The OSA is an entirely self-reported tool regarding occupational competence and value. The 21 item OSA evaluates skills (item 1-11), habituation (12-16) and volition (17-21). Each item contains two sets of 4-point Likert scales, the first scale is about the individuals' performance in various activities (1- I have a lot of problem doing this, 2 - I have some difficult doing this, 3 - I do this well, and 4 points = I do this extremely well) and the second scale is about the values of those activities for the individual 1 - This is not important to me, 2 - This is important to me, 3 -This is more important to me; and 4- This is most important to me)
Objective Achievement Motivation Test - OLMT):
Time frame: Change from Baseline and to the 2 months
The OLMT is a test which is used for Job \& Career replacement and academic testing by assessing examinee's achievement motivation under different circumstances. The OLMT consists of 3 subtests, these 3 subtests include a particular stimulus that motivates respondent's performance: the task itself, setting own goals, and from competition. The test also evaluates the match or mismatch between the set goals and actual performance (aspiration level). For testing; the respondent requires to move a prescribed route cell by cell by pressing two buttons (red and green) repeatedly in ten seconds. For the aspiration level, the respondent sets a goal for the test and tries to accomplish the set goal by performing the first test. The final part the respondent competes against a virtual opponent whose speed is slightly above the mean of the first two tests of the respondent. The scoring of the test is performed by a special software
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Background: PubMed 28000421Kocman A, Weber G. Job Satisfaction, Quality of Work Life and Work Motivation in Employees with Intellectual Disability: A Systematic Review. J Appl Res Intellect Disabil. 2018 Jan;31(1):1-22. doi: 10.1111/jar.12319. Epub 2016 Dec 21.
- Background: PubMed 25061773Wehman P, Chan F, Ditchman N, Kang HJ. Effect of supported employment on vocational rehabilitation outcomes of transition-age youth with intellectual and developmental disabilities: a case control study. Intellect Dev Disabil. 2014 Aug;52(4):296-310. doi: 10.1352/1934-9556-52.4.296.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hülya Kayıhan, Prof study chair
Occupational Therapy, head of department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Entering Employment and Sustaining Work Program and vocational rehabilitation in people with Intellectual Disability, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Self-Assessment version 2.2 (OSA 2.2) (time frame: Change from Baseline and to the 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04728074, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.