Parenting StressNCT07669896
Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study
A study testing Occupational Balance Promotion Program in people with Parenting Stress and Mental Health, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting Stress, Mental Health, Occupational Balance
- What is being tested?
- Occupational Balance Promotion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University
Taichung, 402
Yun-Ling Chen, Doctor, 0958226869, yunling.annie@gmail.com
About this 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
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.
Read the 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.
- Conditions
- Parenting Stress, Mental Health, Occupational Balance
- Being tested
- Occupational Balance Promotion Program
- Keywords
- Preschool Parents, Occupational Balance, Parenting Stress, Depression, Anxiety, Group Intervention, Individualized intervention
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Balance Promotion ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Occupational Balance Promotion Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
The BAI will be used to assess anxiety symptoms. Changes in scores from baseline to post-intervention and follow-up assessments will be analyzed.
Measured: 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
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.
Measured: Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start16 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Parenting StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Yun-Ling Chen, Chung Shan Medical University
- Investigators
- Yun-Ling Chen, PhD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669896
- Sponsor's protocol ID
- CS1-24167
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36360377Zaidman-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.
PubMed 20546082Yeh 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.
PubMed 11853348Chen, 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.
PubMed 21780985Wagman 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.
PubMed 24649971Hakansson 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.
PubMed 31524026Dür, 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07669896
- Acronym / sponsor ID
- CS1-24167
- Conditions
- Parenting Stress, Mental Health, Occupational Balance
- Keywords
- Preschool Parents, Occupational Balance, Parenting Stress, Depression, Anxiety, Group Intervention, Individualized intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Occupational Balance Promotion Program | Experimental | Behavioral: Occupational Balance Promotion ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Balance Promotion ProgramAn 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. | Behavioural | Occupational Balance Promotion Program |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- BackgroundPan, 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.
- BackgroundChe, 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: PubMed 36360377Rios 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.
- Background: PubMed 20546082Zaidman-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.
- Background: PubMed 11853348Yeh 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.
- BackgroundChen, 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: PubMed 21780985Wagman 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.
- Background: PubMed 24649971Wagman 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.
- Background: PubMed 31524026Hakansson 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.
- BackgroundDür, 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun-Ling Chen, PhD principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Balance Promotion Program in people with Parenting Stress and Mental Health, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun-Ling Chen, PhD (886-4-24730022#12394, yunling@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07669896, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.