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Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program (PROTECT+)

Primary Purpose

Mental Disorder

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

About this trial

This is an interventional treatment trial for Mental Disorder

Eligibility Criteria

9 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adolescents aged 9 to 19 years Self-selection

Exclusion Criteria:

Severe comorbid mental health disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PROTECT+

    Arm Description

    The PROTECT+ intervention group is a self-selected sample, which receives the PROTECT+ group therapy (4 modules in 4 subsequent weeks à 100 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).

    Outcomes

    Primary Outcome Measures

    Changes in IUD symptom severity (self-report)
    IUD symptom severity is assessed by the Compulsive Internet Use Scale (CIUS; Meerkerk, Van Den Eijnden, Vermulst & Garretsen, 2009). The CIUS is a broadly used and validated questionnaire including 14 Items assessing IUD.
    Changes in (I)GD/IUD symptom severity (self-report and parental report)
    (I)GD/IUD symptom severity is assessed via self-reports and via parental reports by the Video Game Dependency Scale (Computerspielabhängigkeitsskala; CSAS; Rehbein, Baier, Kleimann & Mößle, 2015). The CSAS questionnaire has been adapted by including non-gaming IU.
    Changes in (I)GD/IUD symptom severity (Clinical Interview based on DSM-5)
    At 12-months follow-up, we conduct a clinical interview based on the criteria of IGD according to the DSM-5. We adapted the criteria by non-gaming subtypes to assess IUD.

    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 (Depressionsinventar für Kinder und Jugendliche; 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) behavior problems, (3) hyperactivity/ attention deficits, (4) interpersonal problems with peers and (5) prosocial behavior and can be used for epidemiological research and as an indicator for emotional, oppositional, antisocial and attention deficit/ hyperactivity disorder. The Total Difficulties Score of the SDQ indicates the risk for developing a mental health 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). This questionnaire assesses anxiety in social interactions and allows for detection and the estimation of severity of social anxiety disorders.
    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 (Allgemeiner Prokrastinationsfragebogen; APROF; Höcker, Engberding & Rist, 2013).
    Social Behavior and Learning Behavior
    For ratings of social competent behavior and academic motivation, we use the German Student Assessment List for Social and Learning Behavior (Schülereinschätzliste für Sozial- und Lernverhalten; SSL; Petermann & Petermann, 2014; Petermann, Petermann & Lohbeck, 2014).
    Self-Efficacy
    Self- efficacy is rated on the German Self-Efficacy Scale (Skala zu Allgemeinen Selbstwirksamkeitserwartung; SWE; Schwarzer & Jerusalem, 1999).

    Full Information

    First Posted
    June 4, 2018
    Last Updated
    June 27, 2018
    Sponsor
    Pädagogische Hochschule Heidelberg
    Collaborators
    Heidelberg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03582839
    Brief Title
    Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program
    Acronym
    PROTECT+
    Official Title
    Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 14, 2016 (Actual)
    Primary Completion Date
    December 23, 2018 (Anticipated)
    Study Completion Date
    April 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pädagogische Hochschule Heidelberg
    Collaborators
    Heidelberg University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background. In the last two decades Internet usage has grown vastly. Pathological Internet usage (IUD; Internet Use Disorder) is associated with severe mental health problems affecting social, academic and daily life functioning. Internet Gaming Disorder (IGD) has been already included in the DSM-V. Recently, the WHO declared to include Gaming Disorder (GD) in the upcoming ICD-11. Despite the increasing rates of adolescents with IUD and (I)GD, affected people are treated unsystematically and there is a lack of evidence based treatment programs. PROTECT+ is a low-threshold, cognitive behavioral short-term group intervention. Methods. 54 patients, aged 9-19 years, received PROTECT+ intervention in Heidelberg, Germany. The PROTECT+ intervention group underwent a cognitive-behavioral 4-session group therapy. Follow-up data were collected at 1, 4, and 12 months after admission. Primary outcome was the change in (I)GD and IUD related symptoms at the 12-months follow-up. Secondary outcomes were changes in comorbid symptoms as well as in problem solving, cognitive restructuring and emotion regulation skills Discussion. Treatment of IUD and IGD is still in its early stages. Recent reviews report increasing research on treatment but also a lack of well-designed studies and evidence based treatment programs. The PROTECT+ intervention is a theory driven and evidence based therapy program which is based on the PROTECT preventive intervention in school settings. In the intervention group a reduction of (I)GD and IUD symptom severity is expected over 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PROTECT+
    Arm Type
    Experimental
    Arm Description
    The PROTECT+ intervention group is a self-selected sample, which receives the PROTECT+ group therapy (4 modules in 4 subsequent weeks à 100 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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    PROTECT+
    Intervention Description
    The early intervention PROTECT+ consists of a cognitive-behavioral 4-session brief-protocol (100 minutes) and targets empirically identified risk factors of (I)GD/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
    Changes in IUD symptom severity (self-report)
    Description
    IUD symptom severity is assessed by the Compulsive Internet Use Scale (CIUS; Meerkerk, Van Den Eijnden, Vermulst & Garretsen, 2009). The CIUS is a broadly used and validated questionnaire including 14 Items assessing IUD.
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Changes in (I)GD/IUD symptom severity (self-report and parental report)
    Description
    (I)GD/IUD symptom severity is assessed via self-reports and via parental reports by the Video Game Dependency Scale (Computerspielabhängigkeitsskala; CSAS; Rehbein, Baier, Kleimann & Mößle, 2015). The CSAS questionnaire has been adapted by including non-gaming IU.
    Time Frame
    baseline, 1 month, 4-months, 12-months
    Title
    Changes in (I)GD/IUD symptom severity (Clinical Interview based on DSM-5)
    Description
    At 12-months follow-up, we conduct a clinical interview based on the criteria of IGD according to the DSM-5. We adapted the criteria by non-gaming subtypes to assess IUD.
    Time Frame
    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 (Depressionsinventar für Kinder und Jugendliche; 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) behavior problems, (3) hyperactivity/ attention deficits, (4) interpersonal problems with peers and (5) prosocial behavior and can be used for epidemiological research and as an indicator for emotional, oppositional, antisocial and attention deficit/ hyperactivity disorder. The Total Difficulties Score of the SDQ indicates the risk for developing a mental health 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). This questionnaire assesses anxiety in social interactions and allows for detection and the estimation of severity of social anxiety disorders.
    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 (Allgemeiner Prokrastinationsfragebogen; 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 behavior and academic motivation, we use the German Student Assessment List for Social and Learning Behavior (Schülereinschätzliste für Sozial- und Lernverhalten; 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 (Skala zu Allgemeinen Selbstwirksamkeitserwartung; SWE; Schwarzer & Jerusalem, 1999).
    Time Frame
    baseline, 1 month, 4-months, 12-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adolescents aged 9 to 19 years Self-selection Exclusion Criteria: Severe comorbid mental health disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katajun Lindenberg, PhD
    Organizational Affiliation
    Institut für Psychologie der Pädagogischen Hochschule Heidelberg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    33216013
    Citation
    Szasz-Janocha C, Vonderlin E, Lindenberg K. Treatment outcomes of a CBT-based group intervention for adolescents with Internet use disorders. J Behav Addict. 2020 Nov 16;9(4):978-989. doi: 10.1556/2006.2020.00089.
    Results Reference
    derived

    Learn more about this trial

    Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program

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