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

21 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Yun-Ling Chen, PhD
  • Número de telefone: 886-4-24730022#12394
  • E-mail: yunling@csmu.edu.tw

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in OBQ11-C Score From Baseline to Post-Intervention and Follow-Up
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in BDI-II Score From Baseline to Post-Intervention and Follow-Up
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

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

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

21 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de junho de 2026

Primeira postagem (Real)

25 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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