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临床试验/NCT07656272
NCT07656272尚未招募不适用

The Effect of a Developmental Support Program for Parents of Children Aged 1-3 Years in a Family Health Center: An Interventional Study

TC Erciyes University0 个研究点目标入组 60 人开始时间: 2026年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60

研究概览

简要总结

This study aims to evaluate the effectiveness of an online video-based developmental support program for parents of children aged 1-3 years receiving care at a Family Health Center. Approximately 60 parents will be randomly assigned to either an intervention group, which will receive a four-week online developmental support program, or a control group, which will continue to receive usual healthcare services. Data will be collected at baseline, two weeks after the intervention, and at one- and three-month follow-up assessments. The study will examine the effects of the online video-based developmental support program on parents' attitudes toward child development, developmental awareness, parenting self-efficacy, and the quality of the home environment that supports child development.

详细描述

Study Design This study is a randomized controlled, parallel-group experimental trial with pre-test and post-test measurements.

Study Setting The study will be conducted at Şeyh Şamil Family Health Center, one of the Family Health Centers affiliated with the Sivas Provincial Health Directorate. The center was selected because it serves the highest number of children aged 12-36 months among the eligible centers. Child development is monitored according to the Infant, Child, and Adolescent Follow-up Protocol of the General Directorate of Public Health. Nurses provide developmental screening, immunization, anthropometric measurements, risk assessment, early intervention activities, and parental counseling services.

Population and Sample The study population consists of 310 parents with children aged 12-36 months. The sample size was calculated using G*Power version 3.1.9.4 software. Based on Cohen's criteria, a medium effect size (Cohen's d = 0.5), a 95% confidence level (α = 0.05), and 80% statistical power (1 - β = 0.80) were used. Accordingly, a minimum of 30 participants per group (total sample size = 60) was required for an independent samples t-test design. Considering a potential attrition rate of 20%, the final sample size was determined as 60 participants. Participants will be randomly assigned to either the intervention group (n = 30) or the control group (n = 30).

Eligibility Criteria Inclusion Criteria

  • Being the parent of a child aged 12-36 months
  • Child's growth percentile being between the 3rd and 97th percentiles
  • Ability to speak and understand Turkish
  • No prior participation in a similar developmental support program
  • Having internet access and the ability to use a computer, tablet, or smartphone
  • Completion of at least primary school education
  • Ability to read and understand written materials
  • Willingness to participate in the study Exclusion Criteria
  • Missing at least one session of the intervention program
  • Living in an extended family household
  • Experiencing a major psychosocial event within the last six months (e.g., relocation, death of a first-degree relative, or divorce)
  • Adolescent parenthood
  • Having a child with a history of congenital anomalies, chronic illness, or prematurity
  • Having a diagnosed mental health disorder Blinding Due to the nature of the intervention, participants and researchers cannot be blinded. However, statistical and reporting blinding will be implemented. Data will be coded without indicating group allocation, and statistical analyses will be conducted by an independent statistician.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Parents with children aged 12-36 months
  • Children with a percentile value between the 3rd and 97th percentile
  • Able to speak and understand Turkish
  • No previous participation in a similar program
  • Having internet access and the ability to use a computer/laptop, tablet, or smartphone
  • At least primary school graduates
  • Able to read and comprehend written information
  • Willing to participate in the study

排除标准

  • Adolescent parents
  • Parents of children with congenital anomalies, chronic diseases, or a history of prematurity
  • Individuals with a diagnosed mental health disorder

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pınar Ateş

PhD Student, Registered Nurse (RN)

TC Erciyes University

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