NCT02386280

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

December 8, 2014

Last Update Submit

March 5, 2015

Conditions

Keywords

Primary PreventionSubstance-Related DisordersFamily

Outcome Measures

Primary Outcomes (1)

  • Measure the reduction risk factors for the use of drugs

    The outcome will be measured by the Parenting Styles Inventory

    6 months

Study Arms (2)

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 StylesBehavioral: Psicoeducation

Psicoeducation

SHAM COMPARATOR

General information about drugs and ways of prevention

Behavioral: Psicoeducation

Interventions

Motivational Interviewing for Change of Parenting Styles
PsicoeducationBEHAVIORAL
Motivational Interviewing for Change of Parenting StylesPsicoeducation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FUHSPortoAlegre

Porto Alegre, Rio Grande do Sul, 91050000, Brazil

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Helena T Barros, Dra

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DRA

Study Record Dates

First Submitted

December 8, 2014

First Posted

March 11, 2015

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations