Screen Free Time With Friends Feasibility Trial

Sponsor
University of Southern Denmark (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05480085
Collaborator
Novo Nordisk A/S (Industry)
150
1
28

Study Details

Study Description

Brief Summary

The Screen Free Time with Friends Feasibility Trial is a study designed to inform development of a definitive trial. The feasibility trial aims to 1) examine the feasibility of an intervention aimed to limit recreational screen media use and promote more time with peers after school and during weekends among 10-11 year old children, 2) examine participant recruitment and retention rates, 3) examine the feasibility of the data collection plan and completeness of the compliance and outcome assessment, and 4) obtain baseline and follow-up data on the planned full trial primary outcome. The Screen Free Time with Friends Feasibility Trial will be conducted as a non-randomized single group feasibility trial including children, their parents and school and afterschool personal from 3rd grade school classes from different schools in the Region of Southern Denmark. The goal is to include a representative sample of children and parents in the participating 3rd grades, and thus there will be no individual level inclusion and exclusion criteria. A process evaluation and outcome measurements will be conducted to evaluate the feasibility and acceptability of the intervention, the data collection plan, and compliance. A baseline- and follow-up assessment will be carried out for some measurements, while others will be collected continuously during the intervention period.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Screen Free Time With Friends Feasibility Trial
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: School-based extracurricular intervention focusing on screen media use and time spent with friends

Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends
The intervention includes the following components: Within each class parents will engage in two meetings combining education and parent-to-parent communication about 1) the children's leisure time activities, and 2) family and class screen time culture. Children will engage in school hour workshops focusing on the class culture related to screen media use and leisure time activities. Afterschool club personal will engage in a meeting focusing on e.g. activity development and implementation (and how to engage the children in this process) and effective strategies to engage parents. This workshop aims to increase participation rate in the afterschool club. Local stakeholders, e.g., parents, school- and afterschool club personal and others relevant to children's leisure time (e.g., sports clubs) will engage in workshops to adjust the predetermined intervention components (1-3 above) to fit their local context and to develop a local action plan.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of the intervention [Baseline]

    The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires and interviews with parents and school and afterschool club personal focusing on the intervention and measurements will be used to assess acceptability.

  2. Feasibility of the intervention [4-month follow-up]

    The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires and interviews with parents and school and afterschool club personal focusing on the intervention and measurements will be used to assess acceptability.

  3. Feasibility of the intervention [6-month follow-up]

    The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires and interviews with parents and school and afterschool club personal focusing on the intervention and measurements will be used to assess acceptability.

Secondary Outcome Measures

  1. Participant recruitment and retention rate [Baseline and 6-month follow-up]

    Proportion of invited participants included in the study and proportion of participants completing the study.

  2. Compliance to objective physical activity measurement [Baseline and 6-month follow-up]

    Proportion of children wearing the accelerometer (Axivity AX3) for at least four out of seven measurements days at baseline and follow-up (at least one day must be a weekend day).

  3. Compliance to objective screen media use measurement [Baseline and 6-month follow-up]

    Proportion of children and parents with data on objective measured smartphone use.

  4. Compliance to subjective screen media use measurement [Baseline and 6-month follow-up]

    Proportion of parents answering the daily screen-media questionnaire.

  5. Compliance to leisure time activities measurement [6-months (intervention period)]

    Proportion of parents answering a weekly questionnaire focusing on the child's afterschool club participation and time spent with friends during leisure time.

  6. Compliance to wellbeing measurement [Baseline and 6-month follow-up]

    Proportion of answers to a wellbeing questionnaire.

  7. Compliance to screen media addiction measurement [Baseline and 6-month follow-up]

    Proportion of answers to a questionnaire focusing on the children's addiction to screen media.

  8. Compliance to social relations measurement [Baseline and 6-month follow-up]

    Proportion of answers to a questionnaire focusing on children's social relations.

  9. Compliance to SCREENS-Q [Baseline and 6-month follow-up]

    Proportion of parents answering the SCREENS-Q.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • the distance between the school and the related afterschool club is in walking and cycling distance

  • the afterschool club must have potential for improvement (assessed by the municipality)

  • the afterschool club personal must have a wish to develop the afterschool club

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Southern Denmark
  • Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anders Groentved, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT05480085
Other Study ID Numbers:
  • NNF20SH0062965
First Posted:
Jul 29, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 29, 2022