Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05117216 |
| Other study ID # |
PVC_PIU_TAU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
November 1, 2018 |
Study information
| Verified date |
November 2021 |
| Source |
Tel Aviv University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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 (ยต2 = .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.
