Occupational Self-Analysis Programme
Primary Purpose
Occupational Therapy, Intellectual Disability, Acquired Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Occupational self-analysis
Vocational guidance
Usual Rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Occupational Therapy
Eligibility Criteria
Participants with Intellectual disabilities:
Inclusion Criteria:
- Basic skills such as writing, reading or calculation
Exclusion Criteria:
-Unsuitable social behaviour
Participants with Acquired Brain Injury:
Inclusion Criteria:
- Members of an association for people with neurological impairment.
Exclusion Criteria:
- Behavioral problems
- Problems speaking or understanding.
Students:
Inclusion Criteria:
- Occupational therapy student.
Exclusion Criteria:
- Absenteeism
- Lack of suitable social behavior
Sites / Locations
- Universidad Católica San Antonio de Murcia
- Asociación de Daño Cerebral de Málaga (ADACEMA)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control group
Arm Description
Occupational Self-Analysis Programme
Vocational guidance or usual rehabilitation (in the case of ABI participants)
Outcomes
Primary Outcome Measures
SF-36 Health Questionnaire
Evaluation of subjective health perception.
Variables:
Eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Physical component summary (Mean scores of four domains: physical functioning, role limitations caused by physical health problems, bodily pain, and general health) (Range 0-100)
Mental component summary scores (Mean scores of four domains: role limitations caused by emotional problems, vitality, social functioning, and mental health) (Range 0-100)
Roles Checklist
Past, present and future occupational roles (Part 1 of Roles Checklist). Variables:
- Number of roles in each period (Range 0-10).
Focus groups
Qualitative data: Perceived learning and emotions
Participant diary
Perceived learning and emotions in a participant diary after sessions
Secondary Outcome Measures
Full Information
NCT ID
NCT03989388
First Posted
June 13, 2019
Last Updated
June 17, 2019
Sponsor
University of Malaga
Collaborators
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT03989388
Brief Title
Occupational Self-Analysis Programme
Official Title
Occupational Self-Analysis Programme in Participants With Intellectual Disabilities, Acquired Brain Injury and Students
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
Collaborators
Universidad Católica San Antonio de Murcia
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
Introduction There is a growing tendency from Occupational Therapy towards the use of programs based on occupation, which, through significant occupational participation, have shown to obtain beneficial results maintained over time in its participants. For this, these programs carry out processes of occupational self- analysis in which people reflect on the daily activities they usually perform so that they can generate modifications towards more satisfactory routines. However, and despite their proven benefits, these programs have been conducted mainly on older people and in cultural contexts other than Spanish.
The "Occupational Self-Analysis" program, developed in the Spanish context, provides participants with a space where they can learn to analyse the barriers and supports for occupational participation and thus achieve a more significant occupational performance.
Objectives The objective of this study was to assess the effectiveness of the "Occupational Self-Analysis" program on the subjective perception of health and the number of roles in people with and without disabilities. In the same way, the purpose was to analyse the increase or modification of the performance in the Activities of the Daily Life that the participants did, and to know how the social environment supports the individual participation of the participants in meaningful activities.
Method The implementation of the "Occupational Self-Analysis" program was carried out in 3 different populations; people with intellectual disability, people with acquired brain injury (ABI) and University students. The intervention was performed by comparing it with a control group (vocational guidance or usual rehabilitation in the caso of ABI participants). In people with intellectual disability, the experimental group consisted of 12 participants and the control one of 13. In people with ABI, the experimental group involved 5 participants and the control, 7. In university students, the experimental group involved 7 and the control 7. The SF-36 Health Questionnaire was used for the evaluation of subjective health perception and the Roles Checklist (Part 1) to evaluate the number of roles they play in the present and the future. All of them underwent a final focus group and the diary were they wrote their learning and emotions was analyzed to assess the benefits of the program.
Detailed Description
Results A positive trend was observed in all dimensions of the SF-36 Health Questionnaire in people with intellectual disability and ABI. In the experimental group of people with intellectual disability the improvements were significant compared to the control group in the dimensions of role limitations due to physical problems (Z = -2.41, p = .016), role limitations due to emotional problems (Z = - 1.99; p = .046), social function (Z = -3.35; p = .001) and the accumulated scores of the mental component (Z = -2.66; p = .008). On the other hand, the ABI experimental group obtained significant improvements in vitality after the intervention (Z = -2.20, p = .028), not finding statistically significant improvements compared to the control group.
With respect to the number of roles internalized, both the experimental group with intellectual disability and the one presenting ABI experienced a marginally significant increase in the number of roles that participants wanted to develop in the future after taking part in the program.
Both in people with intellectual disability, ABI and students, the program improved the involvement in meaningful activities through the inclusion of new occupations, modification of previous habits or the transformation of solitary activities into social participation activities. In addition, the participants increased their awareness of those factors that influenced their participation in meaningful activities. This meant becoming aware of aspects related to volition, habituation, personal abilities and the environment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Therapy, Intellectual Disability, Acquired Brain Injury, Students, Stroke, Awareness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Occupational Self-Analysis Programme
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Vocational guidance or usual rehabilitation (in the case of ABI participants)
Intervention Type
Behavioral
Intervention Name(s)
Occupational self-analysis
Intervention Description
The "Occupational Self-Analysis" program provides participants with a space where they can learn to analyse the barriers and supports for occupational participation.
Intervention Type
Behavioral
Intervention Name(s)
Vocational guidance
Intervention Description
To explore participant´s job interests and learned how to find a job and define a professional profile.
Intervention Type
Behavioral
Intervention Name(s)
Usual Rehabilitation
Intervention Description
Usual rehabilitation: occupational therapy and/or physiotherapy.
Primary Outcome Measure Information:
Title
SF-36 Health Questionnaire
Description
Evaluation of subjective health perception.
Variables:
Eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Physical component summary (Mean scores of four domains: physical functioning, role limitations caused by physical health problems, bodily pain, and general health) (Range 0-100)
Mental component summary scores (Mean scores of four domains: role limitations caused by emotional problems, vitality, social functioning, and mental health) (Range 0-100)
Time Frame
30 minutes
Title
Roles Checklist
Description
Past, present and future occupational roles (Part 1 of Roles Checklist). Variables:
- Number of roles in each period (Range 0-10).
Time Frame
20 minutes
Title
Focus groups
Description
Qualitative data: Perceived learning and emotions
Time Frame
1 hour
Title
Participant diary
Description
Perceived learning and emotions in a participant diary after sessions
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participants with Intellectual disabilities:
Inclusion Criteria:
- Basic skills such as writing, reading or calculation
Exclusion Criteria:
-Unsuitable social behaviour
Participants with Acquired Brain Injury:
Inclusion Criteria:
- Members of an association for people with neurological impairment.
Exclusion Criteria:
Behavioral problems
Problems speaking or understanding.
Students:
Inclusion Criteria:
- Occupational therapy student.
Exclusion Criteria:
Absenteeism
Lack of suitable social behavior
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Judit Fernández-Solano, PhD
Organizational Affiliation
Universidad Católica San Antonio de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Católica San Antonio de Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain
Facility Name
Asociación de Daño Cerebral de Málaga (ADACEMA)
City
Málaga
ZIP/Postal Code
29004
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
31017354
Citation
Fernandez-Solano AJ, Del Bano-Aledo ME, Rodriguez-Bailon M. From thinking to acting: occupational self-analysis tools for use with people with intellectual disability. A pilot study. J Intellect Disabil Res. 2019 Sep;63(9):1086-1096. doi: 10.1111/jir.12621. Epub 2019 Apr 24.
Results Reference
background
Learn more about this trial
Occupational Self-Analysis Programme
We'll reach out to this number within 24 hrs