- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03989388
Occupational Self-Analysis Programme
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Murcia, España, 30107
- Universidad Católica San Antonio de Murcia
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Málaga, España, 29004
- Asociación de Daño Cerebral de Málaga (ADACEMA)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention Group
Occupational Self-Analysis Programme
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The "Occupational Self-Analysis" program provides participants with a space where they can learn to analyse the barriers and supports for occupational participation.
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Comparador activo: Control group
Vocational guidance or usual rehabilitation (in the case of ABI participants)
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To explore participant´s job interests and learned how to find a job and define a professional profile.
Usual rehabilitation: occupational therapy and/or physiotherapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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SF-36 Health Questionnaire
Periodo de tiempo: 30 minutes
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Evaluation of subjective health perception. Variables:
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30 minutes
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Roles Checklist
Periodo de tiempo: 20 minutes
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Past, present and future occupational roles (Part 1 of Roles Checklist). Variables: - Number of roles in each period (Range 0-10). |
20 minutes
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Focus groups
Periodo de tiempo: 1 hour
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Qualitative data: Perceived learning and emotions
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1 hour
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Participant diary
Periodo de tiempo: 2 hours
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Perceived learning and emotions in a participant diary after sessions
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2 hours
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ana Judit Fernández-Solano, PhD, Universidad Católica San Antonio de Murcia
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Manifestaciones neurológicas
- Heridas y Lesiones
- Manifestaciones neuroconductuales
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Trastornos del neurodesarrollo
- Lesiones Cerebrales
- Discapacidad intelectual
Otros números de identificación del estudio
- Occupational Self-Analysis2016
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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