Primary Health Care ProvidersNCT07168057
Young Children and Screens: Parents' Perspectives and Child Health Nurses' Approaches in a Digital Age
An observational study of Primary Health Care Providers and Early Childhood Behavior, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Health Care Providers, Early Childhood Behavior, Child Health Services
- How many people
- 320 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population for the cross-sectional (qualitative part of the project) consists of: -Parents or primary caregivers of children aged 0-5 years who are enrolled in Child Health Services in Sweden. Participants will be recruited from child health service units located in at least three different regions, including both urban and rural areas, to ensure diversity in geographic and socioeconomic backgrounds. Later part of the project includes parents for the same population for qulitative studies. Nurses working in these regions will also be included in the qualitative part of the study to provide professional perspectives on screen use and digital health services.
Who may be able to join
- Parents whose child/children is/are registered in the Swedish Child Health Care center(s) that participate in the study and that have at least one child at age 0-5 yrs.
- Child health nurses working in the Swedish Child Health Care center(s) that participate in the study
Who cannot join
- Parent not having children registered in the participating health care centers at age 0-5 yrs.
- Child health nurses not working at the participating child health centers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Young Children and Screens: A Study Protocol of Parents' Perspectives and Child Health Nurses' Approaches in a Digital Age
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:
Read more
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)
Read the 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.
- Conditions
- Primary Health Care Providers, Early Childhood Behavior, Child Health Services, Parenting Practices, Caregivers, Nursing Practice
- Keywords
- digital advisory services, child healthcare, nurses, parents, screen use
- Medical subject headings
- Child Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' screen use
Parents are asked about following in SCREEN-Q (modified):
Primary place of work or study, Time spent on screen-based work tasks at home on weekdays and weekends, Time spent on screen-based leisure activities on weekdays and weekends, Types of screen-based leisure activities,
Measured: Day 1
Child's screen use
Parents are asked about following in SCREEN-Q (modified):
Child's Access to Screens, Child's Use of Screen Devices, Child's Ownership of Screen Devices, Time Spent on Screen-Based Activities, Screen Media Habits at Home, Rules for Screen Use, Screen Use During the Day, Multitasking and Social Context of Screen Use, Parental Perceptions of Child's Screen Use, Age When Child Received Own Devices
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Feb 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Health Care ProvidersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsi Tiitinen Mekhail, Karolinska Institutet
- Investigators
- Lise-Lott Rydström, RN., PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168057
- Sponsor's protocol ID
- Karolinska Inst 2025-03424-01
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared for this study/project. The data include sensitive information about young children and their families, and despite anonymization, there remains a risk of re-identification, particularly in small or region-specific samples. Furthermore, the informed consent obtained from participants does not include provisions for broad data sharing, and ethical approval for such sharing has not been granted.
Publications
3. Cohen J. Statistical Power Analysis. Current Directions in Psychological Science. 1992;1(3):98-101.
Klakk H, Wester CT, Olesen LG, Rasmussen MG, Kristensen PL, Pedersen J, Grontved A. The development of a questionnaire to assess leisure time screen-based media use and its proximal correlates in children (SCREENS-Q). BMC Public Health. 2020 May 12;20(1):664. doi: 10.1186/s12889-020-08810-6.
PubMed 323979841. World Health Organization. (2025). World report on social determinants of health equity. WHO. https://www.who.int/teams/social-determinants-of-health/equity-and-health/world-report-on-social-determinants-of-health-equity
Mekhail KT, Blom L, Rydstrom LL. Young children's screen habits and first-time parents' reflections on screen use in socioeconomically disadvantaged Swedish settings: a mixed methods study. BMC Public Health. 2024 Jul 29;24(1):2027. doi: 10.1186/s12889-024-19557-9.
PubMed 39075392
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Children and Screens: A Study Protocol of Parents' Perspectives and Child Health Nurses' Approaches in a Digital Age
- ClinicalTrials.gov ID
- NCT07168057
- Acronym / sponsor ID
- Karolinska Inst 2025-03424-01
- Conditions
- Primary Health Care Providers, Early Childhood Behavior, Child Health Services, Parenting Practices, Caregivers, Nursing Practice
- Keywords
- digital advisory services, child healthcare, nurses, parents, screen use
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for the cross-sectional (qualitative part of the project) consists of: -Parents or primary caregivers of children aged 0-5 years who are enrolled in Child Health Services in Sweden. Participants will be recruited from child health service units located in at least three different regions, including both urban and rural areas, to ensure diversity in geographic and socioeconomic backgrounds. Later part of the project includes parents for the same population for qulitative studies. Nurses working in these regions will also be included in the qualitative part of the study to provide professional perspectives on screen use and digital health services.
Key inclusion criteria (2 listed)
- Parents whose child/children is/are registered in the Swedish Child Health Care center(s) that participate in the study and that have at least one child at age 0-5 yrs.
- Child health nurses working in the Swedish Child Health Care center(s) that participate in the study
Key exclusion criteria (2 listed)
- Parent not having children registered in the participating health care centers at age 0-5 yrs.
- Child health nurses not working at the participating child health centers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parents' screen use
Time frame: Day 1
Parents are asked about following in SCREEN-Q (modified): Primary place of work or study, Time spent on screen-based work tasks at home on weekdays and weekends, Time spent on screen-based leisure activities on weekdays and weekends, Types of screen-based leisure activities,
Child's screen use
Time frame: Day 1
Parents are asked about following in SCREEN-Q (modified): Child's Access to Screens, Child's Use of Screen Devices, Child's Ownership of Screen Devices, Time Spent on Screen-Based Activities, Screen Media Habits at Home, Rules for Screen Use, Screen Use During the Day, Multitasking and Social Context of Screen Use, Parental Perceptions of Child's Screen Use, Age When Child Received Own Devices
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background3. Cohen J. Statistical Power Analysis. Current Directions in Psychological Science. 1992;1(3):98-101.
- Background: PubMed 32397984Klakk H, Wester CT, Olesen LG, Rasmussen MG, Kristensen PL, Pedersen J, Grontved A. The development of a questionnaire to assess leisure time screen-based media use and its proximal correlates in children (SCREENS-Q). BMC Public Health. 2020 May 12;20(1):664. doi: 10.1186/s12889-020-08810-6.
- Background1. World Health Organization. (2025). World report on social determinants of health equity. WHO. https://www.who.int/teams/social-determinants-of-health/equity-and-health/world-report-on-social-determinants-of-health-equity
- Background: PubMed 39075392Mekhail KT, Blom L, Rydstrom LL. Young children's screen habits and first-time parents' reflections on screen use in socioeconomically disadvantaged Swedish settings: a mixed methods study. BMC Public Health. 2024 Jul 29;24(1):2027. doi: 10.1186/s12889-024-19557-9.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared for this study/project. The data include sensitive information about young children and their families, and despite anonymization, there remains a risk of re-identification, particularly in small or region-specific samples. Furthermore, the informed consent obtained from participants does not include provisions for broad data sharing, and ethical approval for such sharing has not been granted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lise-Lott Rydström, RN., PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Health Care Providers and Early Childhood Behavior, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' screen use (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07168057, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.