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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral Occupational Balance Promotion Program
  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.

Primary outcome measures

• Change in OBQ11-C Score From Baseline to Post-Intervention and Follow-Up [Time frame: Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention]

Secondary outcome measures (3)

• Change in BDI-II Score From Baseline to Post-Intervention and Follow-Up [Time frame: 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 [Time frame: 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 [Time frame: Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 36360377
• 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
• 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
• 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.
• 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
• 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

Identifiers

NCT: NCT07669896 · CS1-24167

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗