Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study

NCT07669896 | Not Yet Recruiting

• 1 other identifier: CS1-24167
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to examine the relationships among life balance, parenting stress, and mental health in parents of preschool children, and to develop an individualized life balance promotion program for this population. Parents of preschool children will be recruited to support program development and to evaluate its feasibility and effectiveness.

Conditions

Parenting Stress; Mental Health; Occupational Balance

Keywords

Preschool Parents; Occupational Balance; Parenting Stress; Depression; Anxiety; Group Intervention; Individualized intervention

Outcome Measures

Primary Outcomes (1)

• Change in OBQ11-C Score From Baseline to Post-Intervention and Follow-Up

  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.

  Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention

Secondary Outcomes (3)

• Change in BDI-II Score From Baseline to Post-Intervention and Follow-Up

  Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention

• Change in BAI Score From Baseline to Post-Intervention and Follow-Up

  Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention

• Change in PSI-4-SF Score From Baseline to Post-Intervention and Follow-Up

  Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention

Study Arms (1)

Occupational Balance Promotion Program

EXPERIMENTAL

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.

Behavioral: Occupational Balance Promotion Program

Interventions

Occupational Balance Promotion Program BEHAVIORAL

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.

Occupational Balance Promotion Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead
• National Science and Technology Council, Taiwan: collaborator

Related Publications (10)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 36360377 BACKGROUND

• 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.

  PMID: 20546082 BACKGROUND

• 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.

  PMID: 11853348 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21780985 BACKGROUND

• 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.

  PMID: 24649971 BACKGROUND

• 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.

  PMID: 31524026 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Yun-Ling Chen, PhD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-Ling Chen, PhD

CONTACT

886-4-24730022#12394; yunling@csmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single-arm pilot study using a one-group pretest-posttest design with follow-up assessments at 1 month, 3 months, and 6 months after the intervention.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share