NCT04728074

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 22, 2021

Last Update Submit

January 25, 2021

Conditions

Keywords

self awarenessoccupational therapyvocational rehabilitationintellectual disabilitymotivation

Outcome Measures

Primary Outcomes (2)

  • 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)

    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

    Change from Baseline and to the 2 months

Study Arms (2)

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.

Other: The Entering Employment and Sustaining Work ProgramOther: 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)

Other: vocational rehabilitation

Interventions

A structured, motivation and self-awareness based group intervention

Also known as: Occupational therapy - vocational rehabilitation
Intervention

An individual based, focused on desired job or occupation, face-to-face intervention

Interventioncontrol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 28000421BACKGROUND
  • Wehman 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.

    PMID: 25061773BACKGROUND

MeSH Terms

Conditions

Intellectual Disability

Interventions

Rehabilitation, Vocational

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hülya Kayıhan, Prof

    Occupational Therapy, head of department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single blind, randomized control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 28, 2021

Study Start

February 6, 2020

Primary Completion

May 12, 2020

Study Completion

May 12, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations