Risk and Protective Factors of Children and Adolescents W... | NCT01692054

Studies
Risk and Protective Factors of Children and Adolescents Who Were Hospitalized Due to Alcohol Intoxication

NCT01692054

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

May 21, 2014Estimated

Enrollment

394Actual

Phase

Not provided

Conditions

Alcohol Use Disorders

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

May 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Aug 21, 2012

First Submission Date that Met QC Criteria

Sep 21, 2012

First Posted Date

Sep 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2014

Last Update Posted Date

May 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to improve the prognosis of the development of alcohol consumption by considering a variety of biological, psychological and social risk and protective factors. Therefore, young people who have been hospitalized due to acute alcohol intoxication within the past 5 to 12 years will be interviewed in order to assess aspects of healthy or impaired psychosocial development. The study will also include a control group of young adults who were in hospital due to other medical conditions. The identification of relevant cases will be based on medical records of several children's hospitals. These records will be analysed with regard to potential predictors of developmental hazards and protective factors.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

394Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alcohol intoxicated adolescents		Adolescents who were hospitalized due to acute alcohol intoxication
Control group		adolescents who were hospitalized due to other medical conditions but not alcohol intoxication

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alcohol Use Disorders	Alcohol Use Disorders as measured by the The Alcohol Use Disorders Identification Test	5 to 13 years

Secondary Outcomes

Measure	Description	Time Frame
Self-efficacy		5 to 13 years
Life Satisfaction		5 to 13 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

experimental group:

Inclusion Criteria:

male and female volunteers who were hospitalized due to acute alcohol intoxication from January 1, 2000 to December 31, 2006
written informed consent by the subject
minimum age of 20 years

Exclusion Criteria:

incapability to conduct interview

control group:

Inclusion Criteria:

male and female volunteers who were hospitalized due to other medical conditions but not acute alcohol intoxication from January 1, 2000 to December 31, 2006
written informed consent by the subject
minimum age of 20 years

Exclusion Criteria:

incapability to conduct interview

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

young adults living in Germany who were hospitalized due to alcohol intoxication (experimental group) or other medical conditions (control group) 5 to 12 years ago

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrich Zimmermann, Dr	Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden		Dresden	Saxony	01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided