- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07728344
Effects of an SMS-Based Parenting Intervention on Anxiety Symptoms in Preschool Children
Effects of a Mobile Health-Based Ecological Momentary Parenting Intervention on Anxiety Symptoms in Preschool-Aged Children: A Randomized Controlled Trial
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bilin Zheng
- Phone Number: +8618656665022
- Email: 18656665022@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants receive ecological momentary parenting intervention via text messages and WeChat public account
|
Participants will receive an ecological momentary parenting intervention delivered via parenting text messages and posts on a WeChat public account.
The intervention focuses on emotion recognition, anxiety soothing, establishing regular routines, and reasonable screen use management.
|
|
Active Comparator: Control Group
Participants receive general pediatric health education text messages.
|
Participants will receive general pediatric health science popularization text messages that do not include content related to child emotion management, anxiety intervention, or screen use management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preschool Anxiety Scale
Time Frame: 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
|
Baseline and immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ScreenQ Scale
Time Frame: Baseline and immediately post-intervention
|
The ScreenQ is a 16-item parent-reported measure of screen-based media use in young children.
It assesses screen access, frequency of screen use, screen content, and caregiver-child co-viewing practices.
Item scores are summed to produce a total score ranging from 0 to 26.
Higher scores indicate greater inconsistency with recommended screen-media practices
|
Baseline and immediately post-intervention
|
|
Social Competence and Behavior Evaluation Scale-30
Time Frame: Baseline and immediately post-intervention
|
The Social Competence and Behavior Evaluation Scale-30 (SCBE-30) is a 30-item parent-reported measure of social-emotional competence and behavioral problems in preschool-aged children.
Each item is rated from 1 to 6.
The scale includes three 10-item subscales: Social Competence, Anger-Aggression, and Anxiety-Withdrawal.
Each subscale score ranges from 10 to 60. Higher Social Competence scores indicate better social competence, whereas higher Anger-Aggression and Anxiety-Withdrawal scores indicate more severe behavioral or emotional problems
|
Baseline and immediately post-intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AHMU-2026-05-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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