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NCT Number: NCT07669896

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    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.

  2. 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

    The BAI will be used to assess anxiety symptoms. Changes in scores from baseline to post-intervention and follow-up assessments will be analyzed.

  3. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yun-Ling Chen, PhD

CONTACT

[email protected]

886-4-24730022#12394

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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