Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-29 @ 2:30 AM
Study NCT ID:
NCT07168057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Young Children and Screens: Parents' Perspectives and Child Health Nurses' Approaches in a Digital Age
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Young Children and Screens: A Study Protocol of Parents' Perspectives and Child Health Nurses' Approaches in a Digital Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall aim of the research project is to investigate screen habits among children (0-5 years) and their parents including nurses' perspective, and further parents' and nurses' experiences of using web-based healthcare advisory services within Swedish child health care (CHC).
The main research questions are:
What is the correlation between children's and their parents' screen use?
How does screen use differ among families with various socioeconomic backgrounds?
How well does the modified SCREEN-Q instrument measure screen use in Swedish conditions?
How do parents perceive their own and their children's screen use and their parental role?
What are parents' views on available advice and recommendations regarding children's screen use?
How do parents use and experience web-based advisory services within health care and Swedish child health care (CHC)?
How do CHC nurses address screen media-related issues within CHC?
What are CHC nurses' experiences with web-based advisory services?
Participants will:
* Complete a survey on screen habits and digital health service use (N ≈ 300)
* Contribute to validation of a modified SCREEN-Q instrument
* Take part in interviews (parents) and focus groups (child health nurses)
The main research questions are:
What is the correlation between children's and their parents' screen use?
How does screen use differ among families with various socioeconomic backgrounds?
How well does the modified SCREEN-Q instrument measure screen use in Swedish conditions?
How do parents perceive their own and their children's screen use and their parental role?
What are parents' views on available advice and recommendations regarding children's screen use?
How do parents use and experience web-based advisory services within health care and Swedish child health care (CHC)?
How do CHC nurses address screen media-related issues within CHC?
What are CHC nurses' experiences with web-based advisory services?
Participants will:
* Complete a survey on screen habits and digital health service use (N ≈ 300)
* Contribute to validation of a modified SCREEN-Q instrument
* Take part in interviews (parents) and focus groups (child health nurses)
Detailed Description:
This study investigates screen habits among children aged 0-5 years and their parents, as well as child health nurses' experiences with screen-related guidance and digital health advisory services within Swedish Child Health Care (CHC). The study is grounded in the WHO framework on social determinants of health (1), recognizing that screen use is influenced by individual, familial, and societal factors.
Study Design and Methodology:
A mixed-methods design is employed. The quantitative component consists of a cross-sectional survey (N=300) using a modified version of the SCREEN-Q instrument (2), adapted for Swedish conditions. Psychometric validation will include translation/back-translation, expert review, pilot testing, factor analysis, and reliability testing (Cronbach's alpha). Data will be collected digitally and via paper forms through local Child Health Care centers across three regions in Sweden.
The qualitative component includes two semi-structured interview studies with parents (N=10-15 per sub-study) and focus group discussions with child health nurses (N=15-24 total). These will explore attitudes toward screen use, perceptions of parental roles, and experiences with digital health services. Interviews and discussions will be recorded and transcribed for analysis.
Data Management and Quality Assurance:
All survey data will be stored in REDCap at Karolinska Institutet, locked by passwords. Paper surveys will be stored in locked cabinets. Data validation procedures include automated range and consistency checks. Manual review will be performed for flagged entries. A data dictionary will be developed for all variables, including coding schemes and definitions.
Source data verification will be conducted by comparing survey responses with recruitment logs and consent forms. No external medical records will be used.
Within the project there will be step-by-step procedures to guide how participants are recruited, how informed consent is collected, and how data is gathered, entered, and analyzed. These procedures will also include instructions for handling any unexpected changes in the study or any other issues that may arise.
Sample Size and Statistical Analysis:
A sample size of 300 was determined based on a medium effect size (Cohen's d = 0.5), α = 0.05, and power = 80% (3), sufficient for psychometric validation and subgroup analyses.
Quantitative data will be analyzed using SPSS. Analyses include descriptive statistics, t-tests, ANOVA, chi-square tests, and regression analyses to examine relationships between screen use and background variables. Psychometric validation will include exploratory factor analysis and reliability testing.
Qualitative data will be analyzed using Thematic/content analyses to identify themes and patterns related to screen use and digital health service experiences.
Missing Data Plan:
Missing data will be handled using multiple imputation techniques for quantitative analysis. For qualitative data, incomplete transcripts will be excluded from thematic coding. All procedures will follow ethical guidelines and data protection regulations.
Study Design and Methodology:
A mixed-methods design is employed. The quantitative component consists of a cross-sectional survey (N=300) using a modified version of the SCREEN-Q instrument (2), adapted for Swedish conditions. Psychometric validation will include translation/back-translation, expert review, pilot testing, factor analysis, and reliability testing (Cronbach's alpha). Data will be collected digitally and via paper forms through local Child Health Care centers across three regions in Sweden.
The qualitative component includes two semi-structured interview studies with parents (N=10-15 per sub-study) and focus group discussions with child health nurses (N=15-24 total). These will explore attitudes toward screen use, perceptions of parental roles, and experiences with digital health services. Interviews and discussions will be recorded and transcribed for analysis.
Data Management and Quality Assurance:
All survey data will be stored in REDCap at Karolinska Institutet, locked by passwords. Paper surveys will be stored in locked cabinets. Data validation procedures include automated range and consistency checks. Manual review will be performed for flagged entries. A data dictionary will be developed for all variables, including coding schemes and definitions.
Source data verification will be conducted by comparing survey responses with recruitment logs and consent forms. No external medical records will be used.
Within the project there will be step-by-step procedures to guide how participants are recruited, how informed consent is collected, and how data is gathered, entered, and analyzed. These procedures will also include instructions for handling any unexpected changes in the study or any other issues that may arise.
Sample Size and Statistical Analysis:
A sample size of 300 was determined based on a medium effect size (Cohen's d = 0.5), α = 0.05, and power = 80% (3), sufficient for psychometric validation and subgroup analyses.
Quantitative data will be analyzed using SPSS. Analyses include descriptive statistics, t-tests, ANOVA, chi-square tests, and regression analyses to examine relationships between screen use and background variables. Psychometric validation will include exploratory factor analysis and reliability testing.
Qualitative data will be analyzed using Thematic/content analyses to identify themes and patterns related to screen use and digital health service experiences.
Missing Data Plan:
Missing data will be handled using multiple imputation techniques for quantitative analysis. For qualitative data, incomplete transcripts will be excluded from thematic coding. All procedures will follow ethical guidelines and data protection regulations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: