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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07669896
Enrollment
30
Registered
2026-06-25
Start date
2026-07-01
Completion date
2027-12-01
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health, Occupational Balance, Parenting Stress

Keywords

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

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.

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

BEHAVIORALOccupational 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.

Sponsors

Chung Shan Medical University
Lead SponsorOTHER
National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in OBQ11-C Score From Baseline to Post-Intervention and Follow-UpBaseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the interventionThe 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.

Secondary

MeasureTime frameDescription
Change in BDI-II Score From Baseline to Post-Intervention and Follow-UpBaseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the interventionThe BDI-II will be used to assess depressive symptoms. Changes in scores from baseline to post-intervention and follow-up assessments will be analyzed.
Change in BAI Score From Baseline to Post-Intervention and Follow-UpBaseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the interventionThe BAI will be used to assess anxiety symptoms. Changes in scores from baseline to post-intervention and follow-up assessments will be analyzed.
Change in PSI-4-SF Score From Baseline to Post-Intervention and Follow-UpBaseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the interventionThe 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.

Contacts

CONTACTYun-Ling Chen, PhD
yunling@csmu.edu.tw886-4-24730022#12394
PRINCIPAL_INVESTIGATORYun-Ling Chen, PhD

Chung Shan Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026