- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07669896
Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study
A Wonderful Life is Not a Dream-A Pilot Study on the Development and Effectiveness Validation of the Life Balance Improvement Program for Parents of Preschool Children
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a feasibility and preliminary effectiveness study of the life balance promotion program for parents of preschool children developed in the first year of the project. A one-group pretest-posttest design will be used. The overall study design and recruitment procedure are shown in Figure 1. The program is designed as a group-based intervention combined with individualized goal setting and telephone follow-up consultation to address each participant's personal life balance needs. Parents will be recruited through parenting centers or childcare centers. A total of 20 parents are expected to complete the study. Assuming a screening rate of 30%, 30 parents will be recruited. The intervention will consist of weekly group sessions conducted once per week, 2 hours per session, for 8 weeks in an appropriate setting, with individualized consultation provided during the intervention period. Because the program includes a group intervention format and optimal group size is considered, the study will be conducted in two cohorts, with 10 participants in each cohort. In addition, the researcher will provide telephone follow-up consultation 1 to 3 days before each group session.
At baseline (T0), the researcher will explain the study purpose, obtain informed consent, and conduct depression and anxiety screening to confirm that participants have at least mild levels of depression or anxiety and are able to participate in the study. A basic information form and the Canadian Occupational Performance Measure will then be administered to identify each participant's major life goals. Based on the assessment results, the researcher will adjust the group intervention content to ensure that it meets the individualized needs of participants in each cohort. Before the intervention begins, pretest data will be collected, including the basic information form, Occupational Balance Questionnaire, Occupational Questionnaire, Parenting Stress Scale, depression scale, and anxiety scale. The total assessment time is expected to be approximately 30 minutes. Posttest assessment will be conducted immediately after the intervention (T1), and follow-up assessments will be conducted at 1 month, 3 months, and 6 months after the intervention (T2, T3, and T4). The questionnaires administered at T1, T2, T3, and T4 will include the Canadian Occupational Performance Measure, Occupational Balance Questionnaire, Occupational Questionnaire, Parenting Stress Scale, depression scale, and anxiety scale. At T1, participants will also be interviewed regarding their experiences of program participation. The procedures for the second cohort will be the same as those for the first cohort. Recruitment is expected to take approximately 2 months. Including program planning, implementation, and follow-up assessments for a single cohort, the study is expected to take 8 months, and the entire project is expected to be completed about 12 months. After study completion, participants will receive feedback and appreciation for their participation. Changes in questionnaire scores will be used to evaluate the effectiveness of the life balance promotion program, and the interview data collected at T1 will be used to assess the feasibility of the program.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yun-Ling Chen, PhD
- Número de teléfono: 886-4-24730022#12394
- Correo electrónico: yunling@csmu.edu.tw
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Parents aged 18 to 65 years who have at least one preschool child aged 0 to 6 years
- The primary caregiver of the child
- Self-perceived poor life balance or high parenting stress
- Self-perceived depressive or anxiety symptoms, with at least mild depression as indicated by the Beck Depression Inventory, or at least mild anxiety as indicated by the Beck Anxiety Inventory
- Able to communicate in Mandarin Chinese and comply with the study procedures, including interviews and self-administered questionnaires
Exclusion Criteria:
- The child has been diagnosed by a physician with a major physical illness, mental illness, or neurodevelopmental disorder
- The parent has been diagnosed by a physician with a major physical or mental illness requiring long-term treatment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Occupational Balance Promotion Program
Participants will receive an 8-week group-based occupational balance promotion program combined with individualized goal setting and telephone follow-up consultation.
Group sessions will be conducted once weekly for 2 hours each.
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An 8-week group-based occupational balance promotion program for parents of preschool children, combined with individualized goal setting and telephone follow-up consultation.
The program will be delivered once weekly in 2-hour group sessions, with telephone consultation provided 1 to 3 days before each session to address participants' individual needs related to occupational balance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in OBQ11-C Score From Baseline to Post-Intervention and Follow-Up
Periodo de tiempo: Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
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The OBQ11-C will be used to assess participants' perceived occupational balance.
Changes in scores from baseline to post-intervention and follow-up assessments will be used to evaluate the effects of the intervention.
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Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in BDI-II Score From Baseline to Post-Intervention and Follow-Up
Periodo de tiempo: Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
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The BDI-II will be used to assess depressive symptoms.
Changes in scores from baseline to post-intervention and follow-up assessments will be analyzed.
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Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
|
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Change in BAI Score From Baseline to Post-Intervention and Follow-Up
Periodo de tiempo: Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
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The BAI will be used to assess anxiety symptoms.
Changes in scores from baseline to post-intervention and follow-up assessments will be analyzed.
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Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
|
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Change in PSI-4-SF Score From Baseline to Post-Intervention and Follow-Up
Periodo de tiempo: Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
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The PSI-4-SF will be used to assess parenting stress.
Changes in scores from baseline to post-intervention and follow-up assessments will be analyzed.
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Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yun-Ling Chen, PhD, Chung Shan Medical University
Publicaciones y enlaces útiles
Publicaciones Generales
- Hakansson C, Wagman P, Hagell P. Construct validity of a revised version of the Occupational Balance Questionnaire. Scand J Occup Ther. 2020 Aug;27(6):441-449. doi: 10.1080/11038128.2019.1660801. Epub 2019 Sep 14.
- Wagman P, Hakansson C. Introducing the Occupational Balance Questionnaire (OBQ). Scand J Occup Ther. 2014 May;21(3):227-31. doi: 10.3109/11038128.2014.900571. Epub 2014 Mar 21.
- Wagman P, Hakansson C, Bjorklund A. Occupational balance as used in occupational therapy: a concept analysis. Scand J Occup Ther. 2012 Jul;19(4):322-7. doi: 10.3109/11038128.2011.596219. Epub 2011 Jul 25.
- Pan, A. W., & Hsu, W. L. (2008). Application of Rasch measurement model in the construct validity of the Beck Depression Inventory-II. Formosan Journal of Medicine, 12(3), 284-291.
- Che, H. H., Lu, M. L., Chen, H. C., Chang, S. W., & Lee, Y. J. (2006). Validation of the Chinese version of the Beck Anxiety Inventory. Formosan Journal of Medicine, 10(4), 447-454.
- Rios M, Zekri S, Alonso-Esteban Y, Navarro-Pardo E. Parental Stress Assessment with the Parenting Stress Index (PSI): A Systematic Review of Its Psychometric Properties. Children (Basel). 2022 Oct 28;9(11):1649. doi: 10.3390/children9111649.
- Zaidman-Zait A, Mirenda P, Zumbo BD, Wellington S, Dua V, Kalynchuk K. An item response theory analysis of the Parenting Stress Index-Short Form with parents of children with autism spectrum disorders. J Child Psychol Psychiatry. 2010 Nov;51(11):1269-77. doi: 10.1111/j.1469-7610.2010.02266.x.
- Yeh CH, Chen ML, Li W, Chuang HL. The Chinese version of the Parenting Stress Index: a psychometric study. Acta Paediatr. 2001 Dec;90(12):1470-7. doi: 10.1111/j.1651-2227.2001.tb01615.x.
- Chen, Y. L., Ko, W. T., Su, P. C., Hsieh, M. H., Liao, Y. T., Ju, P. C., et al. (2024). Psychometric properties of the Occupational Balance Questionnaire 11-Chinese version (OBQ11-C): Classical test theory and Rasch analysis. Paper presented at the AOTA INSPIRE 2024 Annual Conference & Expo, Orlando, FL, USA.
- Dür, M., Unger, J., Stoffer, M., Drăgoi, R., Kautzky-Willer, A., Fialka-Moser, V., et al. (2015). Definitions of occupational balance and their coverage by instruments. British Journal of Occupational Therapy, 78(1), 4-15. doi:10.1177/0308022614561235
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CS1-24167
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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