CClinicalTrials.gg
CompletedNCT05117216PVC_PIU_TAUUpdated Nov 12, 2021

Examining the Efficacy of "Parental Vigilant Care" for Reducing Problematic Internet Usage

An interventional study of Parental Vigilant Care (Parental training) and Technological Parental Monitoring in Addiction Psychological, sponsored by Tel Aviv University. Completed. Per ClinicalTrials.gov, last updated 2021-11-12.

Sponsored by Tel Aviv University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 9 months after the study started (first participant enrolled Jan 2016, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
297
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

BACKGROUND: One of the most disturbing phenomena regarding the digital age is Problematic Internet Use (PIU) among adolescents (12-16). PIU is defined as a functioning impairment due to: (1) internet excessive use that may lead to the neglect of developmental tasks, or (2) unsafe use which includes viewing inappropriate content, abusive encounters, or commercial exploitation. Clinical and research experience shows that parental involvement plays a critical role in reducing risk behaviors among adolescents in various domains. Despite the ample literature regarding parental involvement, few studies have evaluated the efficacy of parental involvement on adolescents' PIU in reducing functional impairment and designing a safe digital environment. One of the most investigated theoretical approaches in this field is Parental Monitoring (PM). PM is defined as a set of parental practices that aim to monitor and supervise adolescent activities. Despite evidence that PM is effective in reducing risk behaviors among adolescents, PM also has some drawbacks. Studies have demonstrated that it may be perceived as rigid parental control, thereby damaging internalization of parental presence, and potentially sabotaging adolescents' growing independence and autonomy. In the digital world, rigid PM can be defined as using filtering and surveillance applications that enable parents to closely monitor and enforce strict rules regarding their child's internet use. This approach is defined as in the current study as "Technological Parental Monitoring" (TPM). On the other hand, "Parental Vigilant Care" (PVC), is theoretically conceptualized as an alternative parental involvement approach that addresses the weaknesses of PM. By implementing PVC principles, parents develop a positive and non-judgmental dialogue with their children regarding domains the participants are concerned about. Additionally, parents determine their level of active involvement in a flexible manner, specific to the risks presented by their children. By executing decisive and consistent parental involvement, parents strengthen their presence in their children's digital world, therefore, reducing PIU by internalization of safe digital behavior.

OBJECTIVES: The current study aims to examine the efficacy of using digital parental control, according to TPM approach, in comparison with flexible integration of positive parental presence with setting boundaries, according to PVC approach. These approaches will be compared in light of the following outcomes: (1) increasing effective parental involvement in PIU of their adolescent children, (2) reducing PIU and improving adolescent's functioning, and (3) internalizing parental values regarding safe digital activities by children, in order to maintain a parental presence over time.

METHOD: To examine these objectives, a randomized controlled trial was conducted.

Sample size calculation: To assess sample size, the investigators used G-Power software, assuming type 1 error of 5%, power 80%, and analysis of variance, repeated measures with three measurement points, a moderate effect size of time X group interaction (µ2 = .15). The minimum sample size required to meet these assumptions was 134 participants. The final sample consisted of 157 adolescents, in addition to their parents (one parent for each adolescent), yielding a total sample size of 314 participants.

Two-hundred and 297 parents and their children (12-16 y/o) were randomly assigned to four groups: (1) Group parental training according to PVC approach; (2) installation of filtering devices on adolescents' mobile phones and setting them for reducing time use and prohibiting inappropriate content (TPM); (3) combining both group parental training and installation of filtering devices (PVC + TPM) and (4) control group that did not receive any intervention.

Three types of measures were used: (A) Self-reported questionnaires completed by parents: Parental Helplessness for Internet Supervision, Internet Parental Styles, Norms for Unsafe Internet Behaviour, Parental Knowledge of the child's online activities, Family Environment and Adolescent's Functioning (B) Self-reported questionnaires completed by adolescent: Problematic Internet Use and unsafe internet behavior (C) Cellular internet usage retrieved directly from adolescents' mobile devices including total time online, as well as time by specific contents (video games, pornography, gambling, YouTube and social networking sites). The self-report questionnaires were gathered at three time points - before intervention (T1), immediately after termination of intervention (T2) and after 8 weeks follow-up (T3). The online activities data were gathered continuously for 12 weeks (a baseline week, 3 weeks of intervention and 8 weeks of follow-up).

Data Analysis:

Data were analyzed using SPSS version 25. First, descriptive statistics were produced using means and standard deviations for all variables. Group comparisons on demographic variables were conducted using chi-square tests for categorical variables and t- tests for continuous variables. Intervention effects were examined using intent-to-treat analyses. The groups were compared with self-reported measures using repeated measures Analysis of Covariance, examining interaction effect between time (within-subject) and group (between-subject). In these analyses, the expectation to benefit from treatment was controlled. Post-hoc corrections were used for to further examine the significant two-way interactions, and depicted the effect sizes using Cohen's d's both between baseline (T0) and post-intervention (T1), and also between post-intervention (T1) and follow-up (T2). Time of online activity was analyzed using Multi-Level Modeling (MLM) since average daily time online per-week (12 weeks) was nested in the child's group (PVC vs. Control). In addition, to examine the persistence of improvement achieved during intervention, change in average time online between intervention period (3 weeks) and the follow-up period (8 weeks) was tested.

02

Conditions studied

  • Addiction Psychological

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Keywords

  • Problematic Internet Use
  • Parental Vigilant Care
  • Parental Training
03

In context

Behavior, Addictive

540 studies on the registry are indexed under Behavior, Addictive; 134 are open to participants now.

This study's enrollment of 297 is above the median of 72 across 391 interventional studies indexed under Behavior, Addictive.

Browse Behavior, Addictive studies →

Lead sponsor

Tel Aviv University is the lead sponsor of 100 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
297 participants (actual)

Study arms

  • Experimental
    Parental Vigilant Care

    3 sessions of group parental training

    Behavioral: Parental Vigilant Care (Parental training)

  • Active comparator
    Technological Parental Monitoring

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

    Behavioral: Technological Parental Monitoring

  • Active comparator
    PVC + TPM

    combining both group parental training and installation of filtering devices

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

  • No intervention
    Control

    Control group that did not receive any intervention

Interventions

  • BehavioralParental Vigilant Care (Parental training)
  • BehavioralTechnological Parental Monitoring
06

What researchers measure

Primary outcomes

  1. Internet use (hours/day) by Adolescence

    Time online using mobile

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

Secondary outcomes

  1. Parental Helplessness for Internet Supervision

    Self-reported scale: 1-Lowest Parental Helplessness, to 7-Most severe Parental Helplessness

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

  2. Adolescent's Functioning Impairment

    Self-reported scale: 1-Mild Functioning Impairment , to 7-Most severe Functioning Impairment

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

  3. Family Environment

    Self-reported scale: 1- Poor Family Environment , to 7-Extremely Positive Family Environment

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05117216
Lead sponsor
Tel Aviv University
Responsible party
Yaron Sela (PhD, Principal Investigator, Tel Aviv University) — Principal investigator
First posted
Nov 11, 2021
Start date
Jan 1, 2016
Primary completion
Nov 1, 2018
Completion
Nov 1, 2018
Last update
Nov 12, 2021

Study contacts

Meir Lahav, Prof.
study chair · Tel Aviv University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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