Occupational TherapyNCT03989388
Occupational Self-Analysis Programme
A study testing Occupational self-analysis, Vocational guidance and Usual Rehabilitation in people with Occupational Therapy and Intellectual Disability, run by University of Malaga at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Occupational Therapy, Intellectual Disability, Acquired Brain Injury
- What is being tested?
- Occupational self-analysis, Vocational guidance and Usual Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2014to Jul 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Basic skills such as writing, reading or calculation
- Members of an association for people with neurological impairment.
- Occupational therapy student.
Who cannot join
- -Unsuitable social behaviour
- Participants with Acquired Brain Injury:
- Behavioral problems
- Problems speaking or understanding.
- Students:
- Absenteeism
- Lack of suitable social behavior
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Asociación de Daño Cerebral de Málaga (ADACEMA)
Málaga, 29004
Universidad Católica San Antonio de Murcia
Murcia, 30107
About this study
Official title: Occupational Self-Analysis Programme in Participants With Intellectual Disabilities, Acquired Brain Injury and Students
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.
Read more
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.
Read the 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.
- Conditions
- Occupational Therapy, Intellectual Disability, Acquired Brain Injury, Students, Stroke, Awareness
- Being tested
- Occupational self-analysis, Vocational guidance, Usual Rehabilitation
- Medical subject headings
- Intellectual Disability, Brain Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational self-analysisBehavioural
The "Occupational Self-Analysis" program provides participants with a space where they can learn to analyse the barriers and supports for occupational participation.
Vocational guidanceBehavioural
To explore participant´s job interests and learned how to find a job and define a professional profile.
Usual RehabilitationBehavioural
Usual rehabilitation: occupational therapy and/or physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Occupational Self-Analysis Programme Receives: Behavioral: Occupational self-analysis |
| Control group | Active comparator | Vocational guidance or usual rehabilitation (in the case of ABI participants) Receives: Behavioral: Vocational guidance; Behavioral: Usual Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 minutes
Roles Checklist
Past, present and future occupational roles (Part 1 of Roles Checklist). Variables:
- Number of roles in each period (Range 0-10).
Measured: 20 minutes
Focus groups
Qualitative data: Perceived learning and emotions
Measured: 1 hour
Participant diary
Perceived learning and emotions in a participant diary after sessions
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study startOct 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational TherapyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia
- Responsible party
- Principal investigator, María Rodríguez Bailón, University of Malaga
- Investigators
- Ana Judit Fernández-Solano, PhD, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989388
- Sponsor's protocol ID
- Occupational Self-Analysis2016
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31017354
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Self-Analysis Programme in Participants With Intellectual Disabilities, Acquired Brain Injury and Students
- ClinicalTrials.gov ID
- NCT03989388
- Acronym / sponsor ID
- Occupational Self-Analysis2016
- Conditions
- Occupational Therapy, Intellectual Disability, Acquired Brain Injury, Students, Stroke, Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia
- Study start
- Oct 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Jun 2019 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Occupational self-analysisOccupational Self-Analysis Programme |
| Control group | Active comparator | Behavioral: Vocational guidance, Behavioral: Usual RehabilitationVocational guidance or usual rehabilitation (in the case of ABI participants) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Basic skills such as writing, reading or calculation
- Members of an association for people with neurological impairment.
- Occupational therapy student.
Key exclusion criteria (7 listed)
- -Unsuitable social behaviour
- Behavioral problems
- Problems speaking or understanding.
- Absenteeism
- Lack of suitable social behavior
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 |
|---|---|---|
| Occupational self-analysisThe "Occupational Self-Analysis" program provides participants with a space where they can learn to analyse the barriers and supports for occupational participation. | Behavioural | Intervention Group |
| Vocational guidanceTo explore participant´s job interests and learned how to find a job and define a professional profile. | Behavioural | Control group |
| Usual RehabilitationUsual rehabilitation: occupational therapy and/or physiotherapy. | Behavioural | Control group |
Primary outcome
SF-36 Health Questionnaire
Time frame: 30 minutes
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
Time frame: 20 minutes
Past, present and future occupational roles (Part 1 of Roles Checklist). Variables: - Number of roles in each period (Range 0-10).
Focus groups
Time frame: 1 hour
Qualitative data: Perceived learning and emotions
Participant diary
Time frame: 2 hours
Perceived learning and emotions in a participant diary after sessions
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 19 Jun 2019.
- Background: PubMed 31017354Fernandez-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.
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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.
Ana Judit Fernández-Solano, PhD principal investigator
Universidad Católica San Antonio de Murcia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational self-analysis, Vocational guidance and Usual Rehabilitation in people with Occupational Therapy and Intellectual Disability, run by University of Malaga at 2 sites in Spain.
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 3 inclusion and 7 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
SF-36 Health Questionnaire (time frame: 30 minutes). The study lists 4 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 NCT03989388, which also lists 1 linked publication.
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 19 Jun 2019.