Prevention of Drug Use in Adolescence: Intervening in Par... | NCT02386280

Studies
Prevention of Drug Use in Adolescence: Intervening in Parenting Styles

NCT02386280

Sponsor

Federal University of Health Science of Porto Alegre

Status

Unknown status

Last Update Posted

Mar 11, 2015Estimated

Enrollment

200Estimated

Phase

Phase 1Phase 2

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing for Change of Parenting Styles
Psicoeducation

Countries

Brazil

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Mar 2015Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Dec 8, 2014

First Submission Date that Met QC Criteria

Mar 5, 2015

First Posted Date

Mar 11, 2015Estimated

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

Mar 5, 2015

Last Update Posted Date

Mar 11, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helena Maria Tannhauser Barros, DRA, Federal University of Health Science of Porto AlegrePrincipal Investigator

Lead Sponsor

Federal University of Health Science of Porto AlegreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To investigate whether brief motivational intervention is associated with the change of parenting style in parents of teenagers seeking to prevent drug use among their children.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Motivational Interviewing for Change of Parenting Styles	Experimental	After measured parental style across the scale, the motivational interviewing will be applied in order to modify the parenting styles of risk for involvement with drug use and maintenance of protective factors. This approach will occur in 5 segments .	Behavioral: Motivational Interviewing for Change of Parenting Styles Behavioral: Psicoeducation
Psicoeducation	Sham Comparator	General information about drugs and ways of prevention	Behavioral: Psicoeducation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational Interviewing for Change of Parenting Styles	Behavioral		Motivational Interviewing for Change of Parenting Styles

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure the reduction risk factors for the use of drugs	The outcome will be measured by the Parenting Styles Inventory	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents of adolescents aged 10-15 years who call for the service call 132 looking for a program to prevent drug use and accept to participate in the study after reading the Statement of Consent

Exclusion Criteria:

Be excluded individuals that are experiencing difficulty in answering the questions and those who refuse to participate in the study elucidated by IC

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Helena T Barros, Dra	Contact	555133038764		helenbar@ufcspa.edu.br

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FUHSPortoAlegre	Recruiting	Porto Alegre	Rio Grande do Sul	91050000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062405	Motivational Interviewing

Ancestor Terms

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided