Youth DrinkingNCT01213108
Effects of the Örebro Prevention Program on Youth Drinking
A study testing Örebro prevention program and Business as usual in people with Youth Drinking, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of 13-16 year old youths in regular parental meetings. The program aims to encourage parents to maintain a restrictive attitude towards youth drinking throughout their children's teenage years, and thereby postpone and reduce… Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Youth Drinking
- What is being tested?
- Örebro prevention program and Business as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,752 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to May 2010
- Phase
- Interventional
- 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 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
STAD, Centre for Psychiatry Research Stockholm, Karolinska Institutet/Stockholm County Council Health Care Provision
Stockholm, 10231
About this study
The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of 13-16 year old youths in regular parental meetings. The program aims to encourage parents to maintain a restrictive attitude towards youth drinking throughout their children's teenage years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by the program developers showed a sustained alcohol-specific restrictivity among parents exposed to the program, and also a reduction on drinking measures among the youths of the exposed parents (Koutakis, Stattin \& Kerr, 2008). This study aims to investigate whether these effects are sustained also when the program has gone into wide dissemination in Sweden.
- Conditions
- Youth Drinking
- Being tested
- Örebro prevention program, Business as usual
- Keywords
- Örebro prevention program, Youth drinking
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Örebro prevention programBehavioural
6 presentations on alcohol-specific parenting practices to parents of 13-16 year olds youth
Business as usualBehavioural
Regular alcohol prevention activities and curricula in Swedish schools
| Study group | Role | What they receive |
|---|---|---|
| Örebro prevention program | Experimental | Not described Receives: Behavioral: Örebro prevention program |
| Control | Active comparator | Business as usual Receives: Behavioral: Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported drunkenness
Self-reported drunkenness among youth
Measured: 12 months
Self-reported drunkenness
Self-reported drunkenness among youth
Measured: 30 months
Secondary outcomes (2)
Self-reported alcohol consumption
Self-reported alcohol consumption among youth
Measured: 12 months
Self-reported alcohol consumption
Self-reported alcohol consumption among youth
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startMar 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Youth DrinkingStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish National Institute of Public Health, Alcohol Research Council of the Swedish Alcohol Retailing Monopoly
- Investigators
- Maria C Bodin, PhD, Principal investigator, Centre for Psychiatry Research Stockholm, Karolinska Institutet/Stockholm County Council Health Care Provision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213108
- Sponsor's protocol ID
- HFÅ 2007/44
- Status last verified
- Sep 2010
- First submitted
- 30 Sep 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bodin MC, Strandberg AK. The Orebro prevention programme revisited: a cluster-randomized effectiveness trial of programme effects on youth drinking. Addiction. 2011 Dec;106(12):2134-43. doi: 10.1111/j.1360-0443.2011.03540.x. Epub 2011 Sep 21.
PubMed 21676046
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Örebro Prevention Program on Youth Drinking
- ClinicalTrials.gov ID
- NCT01213108
- Acronym / sponsor ID
- HFÅ 2007/44
- Conditions
- Youth Drinking
- Keywords
- Örebro prevention program, Youth drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,752 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish National Institute of Public Health, Alcohol Research Council of the Swedish Alcohol Retailing Monopoly
- Study start
- Mar 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Oct 2010 (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.
The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of 13-16 year old youths in regular parental meetings. The program aims to encourage parents to maintain a restrictive attitude towards youth drinking throughout their children's teenage years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by the program developers showed a sustained alcohol-specific restrictivity among parents exposed to the program, and also a reduction on drinking measures among the youths of the exposed parents (Koutakis, Stattin \& Kerr, 2008). This study aims to investigate whether these effects are sustained also when the program has gone into wide dissemination in Sweden.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Örebro prevention program | Experimental | Behavioral: Örebro prevention program |
| Control | Active comparator | Behavioral: Business as usualBusiness as usual |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Örebro prevention program6 presentations on alcohol-specific parenting practices to parents of 13-16 year olds youth | Behavioural | Örebro prevention program |
| Business as usualRegular alcohol prevention activities and curricula in Swedish schools | Behavioural | Control |
Primary outcome
Self-reported drunkenness
Time frame: 12 months
Self-reported drunkenness among youth
Self-reported drunkenness
Time frame: 30 months
Self-reported drunkenness among youth
2 secondary outcomes
Self-reported alcohol consumption
Time frame: 12 months
Self-reported alcohol consumption
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2010.
- Derived from this study: PubMed 21676046Bodin MC, Strandberg AK. The Orebro prevention programme revisited: a cluster-randomized effectiveness trial of programme effects on youth drinking. Addiction. 2011 Dec;106(12):2134-43. doi: 10.1111/j.1360-0443.2011.03540.x. Epub 2011 Sep 21.
Related trials for Youth Drinking
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Recruiting
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Alcohol Use, Adolescent
Not yet recruiting
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
Adolescent Alcohol Use
Recruiting
ChangeGradients: Promoting Adolescent Health Behavior Change
Alcohol Drinking, Self Efficacy
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.
Maria C Bodin, PhD principal investigator
Centre for Psychiatry Research Stockholm, Karolinska Institutet/Stockholm County Council Health Care Provision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Örebro prevention program and Business as usual in people with Youth Drinking, run by Karolinska Institutet at 1 site in Sweden.
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 0 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: finished, as of the sponsor's last update on 1 Oct 2010. 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 Sweden. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported drunkenness (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01213108, which also lists 1 linked publication.
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 1 Oct 2010.