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

21. juni 2026 oppdatert av: Yun-Ling Chen, Chung Shan Medical University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Occupational Balance Promotion Program
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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in OBQ11-C Score From Baseline to Post-Intervention and Follow-Up
Tidsramme: 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.
Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in BDI-II Score From Baseline to Post-Intervention and Follow-Up
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: 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.
Baseline, immediately after the 8-week intervention, and 1 month, 3 months, and 6 months after the intervention

Samarbeidspartnere og etterforskere

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Etterforskere

  • Hovedetterforsker: Yun-Ling Chen, PhD, Chung Shan Medical University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

21. juni 2026

Først innsendt som oppfylte QC-kriteriene

21. juni 2026

Først lagt ut (Faktiske)

25. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

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