Effects of a Mobile Health-Based Ecological Momentary Parenting Intervention on Anxiety Symptoms in Preschool-Aged Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 356
- 主要终点
- Preschool Anxiety Scale
研究概览
简要总结
Excessive screen use and anxiety symptoms in preschool children have become increasingly prominent public health problems. This randomized controlled trial aims to determine whether, compared with a control group, an ecological momentary parenting intervention delivered via text messages and a WeChat public account can reduce screen use, anxiety symptoms, and social-emotional behavior problems in preschool children.
A total of 356 caregiver-child dyads with children aged 3 to 6 years will be randomly assigned to an intervention group with 178 dyads or a control group with 178 dyads. The intervention group will receive an ecological momentary parenting intervention, including text messages and posts on a WeChat public account, focusing on guidance for emotion recognition, anxiety soothing, establishing regular routines, and reasonable screen use management. The control group will receive only general pediatric health science popularization text messages, which do not include content related to child emotion management, anxiety intervention, or screen use management.
The primary outcome is children's anxiety symptoms, assessed by the Spence Preschool Anxiety Scale. Secondary outcomes include children's screen use assessed by the ScreenQ scale and social-emotional behavior problems assessed by the Social Competence and Behavior Evaluation Scale-30 (SCBE-30)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
This study adopts a double-blind design for participants and researchers responsible for data collection and statistical analysis.
Blinding of participants: Parents are only informed that they will randomly receive two types of parenting and health information, without being told their group allocation or which type belongs to the intervention.
Blinding of researchers: The researcher is not involved in random grouping or short message delivery. After the intervention, the assistant provides the researcher with randomly reordered mobile phone numbers for follow-up telephone interviews, and the researcher remains unaware of group allocation during the follow-up. For data analysis, the researcher only receives an anonymized dataset labeled as Group A/B, without knowing which label corresponds to the intervention group or the control group. Unblinding is performed by the assistant only after all statistical analyses are completed.
The assistant who delivers the intervention cannot be blind
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 3 and 6 years of age and their primary caregivers;
- •The primary caregiver possesses a mobile phone with SMS-receiving capability, and is able to read and comprehend Chinese;
- •Provide informed consent to participate in both the intervention and the study assessments.
排除标准
- •The child has a diagnosed neurodevelopmental or psychiatric disorder;
- •The child is undergoing other forms of intervention or psychological therapy at the time of the study;
结局指标
主要结局
Preschool Anxiety Scale
时间窗: Baseline and immediately post-intervention
The Preschool Anxiety Scale is a 28-item parent-reported measure of anxiety symptoms in preschool-aged children. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 112. Higher scores indicate more severe anxiety symptoms
次要结局
- ScreenQ Scale(Baseline and immediately post-intervention)
- Social Competence and Behavior Evaluation Scale-30(Baseline and immediately post-intervention)
研究者
Bilin Zheng
Student
Anhui Medical University