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Efficacy of Internet Use Disorder Prevention (PROTECT)

Primary Purpose

Mental Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PROTECT intervention group
Sponsored by
Pädagogische Hochschule Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Disorders focused on measuring Internet Use Disorder, Internet Gaming Disorder, Cognitive-Behavioral Intervention, Indicated Prevention, Adolescents, Internet Addiction

Eligibility Criteria

12 Years - 18 Years (Child, Adult)Accepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PROTECT intervention group

    Assessment-only control group

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Internet Use Disorder 12-months incidence rate (Clinical Interview for DSM-5 Diagnosis)
    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)
    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
    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
    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
    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
    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
    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
    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
    Procrastination is assessed with the German Questionnaire for Procrastination (APROF; Höcker, Engberding & Rist, 2013).
    Social Behavior and Learning Behavior
    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
    Self- efficacy is rated on the German Self-Efficacy Scale (Allgemeine Selbstwirksamkeitserwartung, SWE; Schwarzer & Jerusalem, 1999).

    Full Information

    First Posted
    September 9, 2016
    Last Updated
    September 19, 2017
    Sponsor
    Pädagogische Hochschule Heidelberg
    Collaborators
    Dietmar Hopp Stiftung
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02907658
    Brief Title
    Efficacy of Internet Use Disorder Prevention
    Acronym
    PROTECT
    Official Title
    A Randomized Efficacy Trial of a Cognitive-Behavioral Intervention to Prevent Internet Use Disorder Onset in Adolescents: the PROTECT Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    April 2018 (Anticipated)
    Study Completion Date
    May 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pädagogische Hochschule Heidelberg
    Collaborators
    Dietmar Hopp Stiftung

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorders
    Keywords
    Internet Use Disorder, Internet Gaming Disorder, Cognitive-Behavioral Intervention, Indicated Prevention, Adolescents, Internet Addiction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    480 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PROTECT intervention group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Assessment-only control group
    Arm Type
    No Intervention
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    PROTECT intervention group
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Internet Use Disorder 12-months incidence rate (Clinical Interview for DSM-5 Diagnosis)
    Description
    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).
    Time Frame
    12 months
    Title
    Internet Use Disorder 12-months incidence rate (Self-Report)
    Description
    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).
    Time Frame
    12 months
    Title
    Changes in Internet Use Disorder prevalence
    Description
    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.
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Secondary Outcome Measure Information:
    Title
    Emotion Regulation
    Description
    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.
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Depressive Symptoms
    Description
    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).
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Comorbid emotional, oppositional, antisocial and attention deficit/ hyperactivity disorders
    Description
    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.
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Anxiety Disorders: Social Anxiety
    Description
    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).
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Anxiety Disorders: Performance and School Anxiety
    Description
    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).
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Procrastination
    Description
    Procrastination is assessed with the German Questionnaire for Procrastination (APROF; Höcker, Engberding & Rist, 2013).
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Social Behavior and Learning Behavior
    Description
    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).
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Self-Efficacy
    Description
    Self- efficacy is rated on the German Self-Efficacy Scale (Allgemeine Selbstwirksamkeitserwartung, SWE; Schwarzer & Jerusalem, 1999).
    Time Frame
    baseline, 1 month, 4-months, 12-months

    10. Eligibility

    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katajun Lindenberg, PhD
    Organizational Affiliation
    University of Education Heidelberg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35179587
    Citation
    Lindenberg K, Kindt S, Szasz-Janocha C. Effectiveness of Cognitive Behavioral Therapy-Based Intervention in Preventing Gaming Disorder and Unspecified Internet Use Disorder in Adolescents: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2148995. doi: 10.1001/jamanetworkopen.2021.48995.
    Results Reference
    derived
    PubMed Identifier
    31936677
    Citation
    Wartberg L, Lindenberg K. Predictors of Spontaneous Remission of Problematic Internet Use in Adolescence: A One-Year Follow-Up Study. Int J Environ Res Public Health. 2020 Jan 9;17(2):448. doi: 10.3390/ijerph17020448.
    Results Reference
    derived
    PubMed Identifier
    29649137
    Citation
    Lindenberg K, Halasy K, Szasz-Janocha C, Wartberg L. A Phenotype Classification of Internet Use Disorder in a Large-Scale High-School Study. Int J Environ Res Public Health. 2018 Apr 12;15(4):733. doi: 10.3390/ijerph15040733.
    Results Reference
    derived
    PubMed Identifier
    29740637
    Citation
    Lindenberg K, Halasy K, Schoenmaekers S. A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol. Contemp Clin Trials Commun. 2017 Mar 29;6:64-71. doi: 10.1016/j.conctc.2017.02.011. eCollection 2017 Jun.
    Results Reference
    derived

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    Efficacy of Internet Use Disorder Prevention

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