A Randomized Efficacy Trial of a Cognitive-Behavioral Intervention to Prevent Internet Use Disorder Onset in Adolescents: the PROTECT Study
试验速览
- 阶段
- 不适用
- 入组人数
- 480
- 主要终点
- Internet Use Disorder 12-months incidence rate (Self-Report)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years(Child, Adult)
- 接受健康志愿者
- 是
入选标准
- •Adolescents aged 12 to 18 years
- •Written informed consent
- •High-risk for IUD (Screening: CIUS >= 20)
排除标准
- •Current IUD diagnosis or treatment
- •Comorbid depression
- •Comorbid anxiety disorder (social phobia or performance anxiety)
研究组 & 干预措施
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).
干预措施: PROTECT intervention group (Behavioral)
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).
结局指标
主要结局
Internet Use Disorder 12-months incidence rate (Self-Report)
时间窗: 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
时间窗: 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.
Internet Use Disorder 12-months incidence rate (Clinical Interview for DSM-5 Diagnosis)
时间窗: 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).
次要结局
- Depressive Symptoms(baseline, 1 month, 4-months, 12-months)
- Comorbid emotional, oppositional, antisocial and attention deficit/ hyperactivity disorders(baseline, 1 month, 4-months, 12-months)
- Anxiety Disorders: Social Anxiety(baseline, 1 month, 4-months, 12-months)
- Emotion Regulation(baseline, 1 month, 4-months, 12-months)
- Anxiety Disorders: Performance and School Anxiety(baseline, 1 month, 4-months, 12-months)
- Procrastination(baseline, 1 month, 4-months, 12-months)
- Social Behavior and Learning Behavior(baseline, 1 month, 4-months, 12-months)
- Self-Efficacy(baseline, 1 month, 4-months, 12-months)
