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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03989388
Other study ID # Occupational Self-Analysis2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date July 2016

Study information

Verified date June 2019
Source University of Malaga
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Occupational self-analysis
The "Occupational Self-Analysis" program provides participants with a space where they can learn to analyse the barriers and supports for occupational participation.
Vocational guidance
To explore participant´s job interests and learned how to find a job and define a professional profile.
Usual Rehabilitation
Usual rehabilitation: occupational therapy and/or physiotherapy.

Locations

Country Name City State
Spain Asociación de Daño Cerebral de Málaga (ADACEMA) Málaga
Spain Universidad Católica San Antonio de Murcia Murcia

Sponsors (2)

Lead Sponsor Collaborator
University of Malaga Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Fernández-Solano AJ, Del Baño-Aledo ME, Rodríguez-Bailón M. From thinking to acting: occupational self-analysis tools for use with people with intellectual disability. A pilot study. J Intellect Disabil Res. 2019 Apr 24. doi: 10.1111/jir.12621. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
30 minutes
Primary Roles Checklist Past, present and future occupational roles (Part 1 of Roles Checklist). Variables:
- Number of roles in each period (Range 0-10).
20 minutes
Primary Focus groups Qualitative data: Perceived learning and emotions 1 hour
Primary Participant diary Perceived learning and emotions in a participant diary after sessions 2 hours
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