Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-31 @ 6:43 PM
Study NCT ID:
NCT02907658
Status:
UNKNOWN
Last Update Posted:
2017-09-21
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Internet Use Disorder Prevention
Sponsor:
Pädagogische Hochschule Heidelberg
Organization:
Study Overview
Official Title:
A Randomized Efficacy Trial of a Cognitive-Behavioral Intervention to Prevent Internet Use Disorder Onset in Adolescents: the PROTECT Study
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: