Efficacy of Internet Use Disorder Prevention

Mental Disorders Clinical Trial

— PROTECT  

Official title:

A Randomized Efficacy Trial of a Cognitive-Behavioral Intervention to Prevent Internet Use Disorder Onset in Adolescents: the PROTECT Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02907658
• Other study ID #: PHHD-PROTECT-101030906
• Status: Active, not recruiting
• Phase: N/A
• First received: September 9, 2016
• Last updated: September 19, 2017
• Start date: September 2015
• Est. completion date: May 2018

Study information

• Verified date: September 2017
• Source: Pädagogische Hochschule Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychotic Disorders

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pädagogische Hochschule Heidelberg	Dietmar Hopp Stiftung

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months
Primary	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).	12 months
Primary	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.	baseline, 1 month, 4-months, 12-months
Secondary	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.	baseline, 1 month, 4-months, 12-months
Secondary	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).	baseline, 1 month, 4-months, 12-months
Secondary	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.	baseline, 1 month, 4-months, 12-months
Secondary	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).	baseline, 1 month, 4-months, 12-months
Secondary	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).	baseline, 1 month, 4-months, 12-months
Secondary	Procrastination	Procrastination is assessed with the German Questionnaire for Procrastination (APROF; Höcker, Engberding & Rist, 2013).	baseline, 1 month, 4-months, 12-months
Secondary	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).	baseline, 1 month, 4-months, 12-months
Secondary	Self-Efficacy	Self- efficacy is rated on the German Self-Efficacy Scale (Allgemeine Selbstwirksamkeitserwartung, SWE; Schwarzer & Jerusalem, 1999).	baseline, 1 month, 4-months, 12-months