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Efficacy of Internet Use Disorder Prevention (PROTECT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907658
First Posted: September 20, 2016
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dietmar Hopp Stiftung
Information provided by (Responsible Party):
Pädagogische Hochschule Heidelberg
  Purpose

Background. The reduction of prevalence rates of Internet Use Disorder (IUD) and its effective treatment are at high priority in both public health and educational policies. School-based preventive interventions facilitate a low-threshold approach for individuals with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated approaches which target adolescents at high-risk show larger effects than universal prevention approaches. Simultaneously, they reduce unnecessary burden for the majority of high-school students that is not at-risk. The PROTECT intervention for indicated prevention of IUD in school settings was developed based on these preventive strategies.

Methods. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in Germany, screened for high-risk of IUD onset, will be randomly assigned to a) PROTECT intervention group or b) assessment only control group. The tested intervention consists of a cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12 months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary outcomes are the reduction of IUD and comorbid symptoms and the promotion of problem solving, cognitive restructuring and emotion regulation skills.

Discussion. The indicated preventive intervention PROTECT follows the APA-guidelines for psychological prevention. It is theory- and evidence-based (guideline 1) and addresses both risk-reduction and strength-promotion (guideline 3), it considers current research and epidemiology (guideline 4) and ethical standards (guideline 5) such as professional secrecy and is designed as a systemic intervention (guideline 8) at the school-level. It is expected that the intervention decreases risk of IUD onset (incidence rate).


Condition Intervention
Mental Disorders Behavioral: PROTECT intervention group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Efficacy Trial of a Cognitive-Behavioral Intervention to Prevent Internet Use Disorder Onset in Adolescents: the PROTECT Study

Further study details as provided by Pädagogische Hochschule Heidelberg:

Primary Outcome Measures:
  • Internet Use Disorder 12-months incidence rate (Clinical Interview for DSM-5 Diagnosis) [ Time Frame: 12 months ]
    We use a clinical interview (blinded rater) based on the criteria of Internet Gaming Disorder according to the DSM-5 at the 12-month follow-up. We adapted the criteria to assess IUD (including gaming and non-gaming subtypes).

  • Internet Use Disorder 12-months incidence rate (Self-Report) [ Time Frame: 12 months ]
    We use the German "Computerspielabhängigkeitsskala" (CSAS; Rehbein, Baier, Kleimann & Mößle, 2015), a self-report questionnaire which assesses DSM-5 criteria for Internet Gaming Disorder proposed in DSM-5 section 3 (American Psychiatric Association, 2013): (1) preoccupation, (2) withdrawal, (3) tolerance, (4) unsuccessful attempts to control, (5) loss of interest in other activities, (6) continued excessive use despite problems, (7) deception (8) maladaptive coping, (9) loss of relationship, job, or educational or career opportunities. We adapted the criteria to assess IUD (including gaming and non-gaming subtypes).

  • Changes in Internet Use Disorder prevalence [ Time Frame: baseline, 1 month, 4-months, 12-months ]
    To measure the IUD prevalence rate over time (at baseline, 1 month, 4-months, 12-months), we use the adapted version of the CSAS questionnaire.


Secondary Outcome Measures:
  • Emotion Regulation [ Time Frame: baseline, 1 month, 4-months, 12-months ]
    For the measurement of emotion regulation the German Questionnaire for Assessment of Emotion Regulation in Children and Adolescents (Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen, FEEL-KJ; Grob & Smolenski, 2011) is used. The questionnaire includes a measure of functional and dysfunctional emotion regulation strategies for the negative emotions fear, sadness and anger.

  • Depressive Symptoms [ Time Frame: baseline, 1 month, 4-months, 12-months ]
    Depressive symptoms are assessed using the German Depression Inventory for Children and Adolescents (DIKJ; Stiensmeier-Pelster, Braune-Krickau, Schürmann & Duda, 2014; Stiensmeier-Pelster, Schürmann & Duda, 1989). The instrument allows for the detection and estimation of severity of depressive disorders according to the DSM-5 criteria (American Psychiatric Association, 2013).

  • Comorbid emotional, oppositional, antisocial and attention deficit/ hyperactivity disorders [ Time Frame: baseline, 1 month, 4-months, 12-months ]

    Comorbid Psychopathology is assessed using the Strength and Difficulties Questionnaire (SDQ; Goodman, Meltzer & Bailey, 2003).

    It includes the 5 scales (1) emotional problems, (2) behaviour problems, (3) hyperactivity/ attention deficits, (4) interpersonal problems with peers and (5) prosocial behaviour and can be used for epidemiological research and as an indicator for emotional, oppositional, antisocial and attention deficit/ hyperactivity disorder.


  • Anxiety Disorders: Social Anxiety [ Time Frame: baseline, 1 month, 4-months, 12-months ]

    We assess social anxiety using the German version of the Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998; Stangier, Heidenreich, Berardi, Golbs & Hoyer, 1999) is used. This questionnaire assesses anxiety in social interactions and al-lows for detection and the estimation of severity of social anxiety disorders.

    2) Performance and school anxiety are assessed with the 7th scale of the German adaption of the Fear Survey Schedule for Children - Revised (Phobiefragebogen für Kinder und Jugendliche, PHOKI Döpfner, Schnabel, Goletz & Ollendick, 2006; Muris & Ollendick, 2002).


  • Anxiety Disorders: Performance and School Anxiety [ Time Frame: baseline, 1 month, 4-months, 12-months ]
    We assess performance and school anxiety with the 7th scale of the German adaption of the Fear Survey Schedule for Children - Revised (Phobiefragebogen für Kinder und Jugendliche, PHOKI Döpfner, Schnabel, Goletz & Ollendick, 2006; Muris & Ollendick, 2002).

  • Procrastination [ Time Frame: baseline, 1 month, 4-months, 12-months ]
    Procrastination is assessed with the German Questionnaire for Procrastination (APROF; Höcker, Engberding & Rist, 2013).

  • Social Behavior and Learning Behavior [ Time Frame: baseline, 1 month, 4-months, 12-months ]
    For ratings of social competent behaviour and academic motivation, we use the German Student Assessment List for Social and Learning Behaviour (SSL; Petermann & Petermann, 2014; Petermann, Petermann & Lohbeck, 2014).

  • Self-Efficacy [ Time Frame: baseline, 1 month, 4-months, 12-months ]
    Self- efficacy is rated on the German Self-Efficacy Scale (Allgemeine Selbstwirksamkeitserwartung, SWE; Schwarzer & Jerusalem, 1999).


Enrollment: 480
Study Start Date: September 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROTECT intervention group
The PROTECT intervention group receives the preventive intervention PROTECT (4 modules in 4 subsequent weeks à 90 min). Participants are assessed at T1 (baseline), T2 (post treatment, 1-month follow-up), T3 (4-months follow-up), and T4 (12-months follow-up).
Behavioral: PROTECT intervention group
The indicated preventive intervention PROTECT consists of a cognitive-behavioral 4-session brief-protocol (90 minutes). It targets empirically identified risk factors of Internet Use Disorder (IUD), i.e. (1) boredom and motivational problems, (2) procrastination and performance anxiety, (3) social behavior and (4) emotion regulation. It addresses both risk-reduction and strength-promotion by cognitive behavioral (CB) interventions such as (1) psychoeducation, (2) cognitive restructuring (identification and modification of dysfunctional cognition), (3) behavior modification (improving problem solving skills, training of functional behavior and reinforcement) as well as (4) improving emotion regulation (training of sensory, imaginative and mindfulness based techniques).
No Intervention: Assessment-only control group
The assessment-only control group is an observational condition without intervention. Participants are assessed at T1 (baseline), T2 (1-month follow-up), T3 (4-months follow-up), and T4 (12-months follow-up).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents aged 12 to 18 years
  • Written informed consent
  • High-risk for IUD (Screening: CIUS >= 20)

Exclusion Criteria:

  • Current IUD diagnosis or treatment
  • Comorbid depression
  • Comorbid anxiety disorder (social phobia or performance anxiety)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907658


Sponsors and Collaborators
Pädagogische Hochschule Heidelberg
Dietmar Hopp Stiftung
Investigators
Principal Investigator: Katajun Lindenberg, PhD University of Education Heidelberg
  More Information

Responsible Party: Pädagogische Hochschule Heidelberg
ClinicalTrials.gov Identifier: NCT02907658     History of Changes
Other Study ID Numbers: PHHD-PROTECT-101030906
First Submitted: September 9, 2016
First Posted: September 20, 2016
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pädagogische Hochschule Heidelberg:
Internet Use Disorder
Internet Gaming Disorder
Cognitive-Behavioral Intervention
Indicated Prevention
Adolescents
Internet Addiction

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders