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Addiction PsychologicalPVC_PIU_TAUNCT05117216

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

A study testing Parental Vigilant Care (Parental training) and Technological Parental Monitoring in people with Addiction Psychological, run by Tel Aviv University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Addiction Psychological
What is being tested?
Parental Vigilant Care (Parental training) and Technological Parental Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
297 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 1 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Examining the Efficacy of "Technological Parental Monitoring" Approach Versus "Parental Vigilant Care" Approach for Reducing Problematic Internet Usage Among Adolescents

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.

Being tested
Parental Vigilant Care (Parental training), Technological Parental Monitoring
Keywords
Problematic Internet Use, Parental Vigilant Care, Parental Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parental Vigilant Care (Parental training)Behavioural

  • Technological Parental MonitoringBehavioural

Study groups in NCT05117216
Study groupRoleWhat they receive
Parental Vigilant CareExperimental3 sessions of group parental training
Receives: Behavioral: Parental Vigilant Care (Parental training)
Technological Parental MonitoringActive comparatorThe installation of filtering devices on adolescents' mobile phones and setting them for reducing time use and prohibiting inappropriate content
Receives: Behavioral: Technological Parental Monitoring
PVC + TPMActive comparatorcombining both group parental training and installation of filtering devices
Receives: Behavioral: Parental Vigilant Care (Parental training); Behavioral: Technological Parental Monitoring
ControlNo interventionControl group that did not receive any intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Internet use (hours/day) by Adolescence

    Time online using mobile

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

Secondary outcomes (3)
  1. Parental Helplessness for Internet Supervision

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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2021
  2. Study start1 Jan 2016
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Participant
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05117216
Sponsor's protocol ID
PVC_PIU_TAU
Acronym
PVC_PIU_TAU
Status last verified
Nov 2021
First submitted
19 Oct 2021
Last updated
12 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Parental Vigilant Care (Parental training) and Technological Parental Monitoring in people with Addiction Psychological, run by Tel Aviv University.

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 3 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: finished, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Internet use (hours/day) by Adolescence (time frame: Reducing time online, through study completion, an average of 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Nov 2021.

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