Substance-Related DisordersPhase 1/2NCT02386280
Prevention of Drug Use in Adolescence: Intervening in Parenting Styles
A Phase 1/2 study testing Motivational Interviewing for Change of Parenting Styles and Psicoeducation in people with Substance-Related Disorders, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Motivational Interviewing for Change of Parenting Styles and Psicoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Be excluded individuals that are experiencing difficulty in answering the questions and those who refuse to participate in the study elucidated by IC
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
FUHSPortoAlegre
Porto Alegre, Rio Grande do Sul, 91050000
Helena T Barros, Dra, 5198575662, helenbar@ufcspa.edu.br
About this study
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.
- Conditions
- Substance-Related Disorders
- Being tested
- Motivational Interviewing for Change of Parenting Styles, Psicoeducation
- Keywords
- Primary Prevention, Substance-Related Disorders, Family
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing for Change of Parenting StylesBehavioural
PsicoeducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Behavioral: Motivational Interviewing for Change of Parenting Styles; Behavioral: Psicoeducation |
| Psicoeducation | Sham comparator | General information about drugs and ways of prevention Receives: Behavioral: Psicoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the reduction risk factors for the use of drugs
The outcome will be measured by the Parenting Styles Inventory
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Maria Tannhauser Barros, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386280
- Sponsor's protocol ID
- AMTEPA
- Status last verified
- Mar 2015
- First submitted
- 8 Dec 2014
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Drug Use in Adolescence: Intervening in Parenting Styles
- ClinicalTrials.gov ID
- NCT02386280
- Acronym / sponsor ID
- AMTEPA
- Conditions
- Substance-Related Disorders
- Keywords
- Primary Prevention, Substance-Related Disorders, Family
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing for Change of Parenting Styles | Experimental | Behavioral: Motivational Interviewing for Change of Parenting Styles, Behavioral: PsicoeducationAfter 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 . |
| Psicoeducation | Sham comparator | Behavioral: PsicoeducationGeneral information about drugs and ways of prevention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Be excluded individuals that are experiencing difficulty in answering the questions and those who refuse to participate in the study elucidated by IC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing for Change of Parenting Styles | Behavioural | Motivational Interviewing for Change of Parenting Styles |
| Psicoeducation | Behavioural | Motivational Interviewing for Change of Parenting Styles, Psicoeducation |
Primary outcome
Measure the reduction risk factors for the use of drugs
Time frame: 6 months
The outcome will be measured by the Parenting Styles Inventory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Motivational Interviewing for Change of Parenting Styles and Psicoeducation in people with Substance-Related Disorders, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena T Barros, Dra (555133038764, helenbar@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the reduction risk factors for the use of drugs (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.