Tokyo, Sept. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058999) titled 'Development of a family-based prevention program for problematic internet use among children and adolescents' on Sept. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - University of Tsukuba
Condition:
Condition - Problematic Internet Use (PIU)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To develop a family-based preventive intervention as a primary prevention program for elementary and junior high school students and to evaluate its effectiveness through a randomized controlled trial.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A 60-minute group session will be conducted every week for 4 weeks
Interventions/Control_2 - Provide a pamphlet on the prevention of PIU
Eligibility:
Age-lower limit - 10
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Children in grades 5 through 9 (elementary grade 5 to junior high grade 3) and their parents
2) Children who use the internet regularly for recreational purposes
3) Those who have provided written informed consent
Key exclusion criteria - 1) Individuals who have difficulty reading, writing, or speaking in Japanese
2) Individuals who are unable to attend at least two of the four sessions
3) Individuals whom the investigators judge to be unsuitable for the safe conduct of this trial
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 28 Day
Date of IRB - 2025 Year 07 Month 28 Day
Anticipated trial start date - 2025 Year 09 Month 08 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067475
Disclaimer: Curated by HT Syndication.
