NCT05117216

Brief Summary

Problematic Internet Use (PIU) and Unsafe Internet Use (UIU) are the two main potential negative consequences of children's online activities. Parents have a vital role in reducing these consequences and shaping a safe digital environment. Parental Vigilant Care (PVC) is a systematic approach that integrates active and restrictive mediation practices, in which parents regulate their involvement according to the alarm signs the parents detect. This study is a randomized controlled trial designed to assess the efficacy of the PVC parent training. Families were randomly assigned to either (1) PVC group (2) Technological Parental Monitoring group (3) combining both group parental training and installation of filtering devices (PVC + TPM) or (4) Control group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

2.8 years

First QC Date

October 19, 2021

Last Update Submit

November 11, 2021

Conditions

Keywords

Problematic Internet UseParental Vigilant CareParental Training

Outcome Measures

Primary Outcomes (1)

  • Internet use (hours/day) by Adolescence

    Time online using mobile

    Reducing time online, through study completion, an average of 12 weeks

Secondary Outcomes (3)

  • Parental Helplessness for Internet Supervision

    Improving parental helplessness, through study completion, an average of 12 weeks

  • Adolescent's Functioning Impairment

    Improving adolescent's functioning, through study completion, an average of 12 weeks

  • Family Environment

    Improving family environment, through study completion, an average of 12 weeks

Study Arms (4)

Parental Vigilant Care

EXPERIMENTAL

3 sessions of group parental training

Behavioral: Parental Vigilant Care (Parental training)

Technological Parental Monitoring

ACTIVE COMPARATOR

The installation of filtering devices on adolescents' mobile phones and setting them for reducing time use and prohibiting inappropriate content

Behavioral: Technological Parental Monitoring

PVC + TPM

ACTIVE COMPARATOR

combining both group parental training and installation of filtering devices

Behavioral: Parental Vigilant Care (Parental training)Behavioral: Technological Parental Monitoring

Control

NO INTERVENTION

Control group that did not receive any intervention

Interventions

PVC + TPMParental Vigilant Care
PVC + TPMTechnological Parental Monitoring

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Functioning deterioration of the child (age 12-16) due to online activity in the past 6 months in at least one of the following domains: school, social relationships, participation in family activities, sleeping patterns, and mood (according to parents' self-report).
  • The child owns a mobile phone.

You may not qualify if:

  • A psychiatric diagnosis of the child
  • A significant personal crisis in the previous 12 months (e.g., divorce, loss of a significant person)
  • A parental control application is installed on their children's mobile phones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Meir Lahav, Prof.

    Tel Aviv University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Principal Investigator

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 11, 2021

Study Start

January 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share