Substance UseNCT01138982
Effectiveness Study of a Swedish Youth Mentoring Program
A study testing Youth Mentoring program in people with Substance Use, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and exclusion of study participants are elaborated in collaboration with the providing NGO, and the program is given as customary. Read more about this study
- Who is it for?
- Ages 14 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Youth Mentoring program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2007to Jun 2009
- 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 14 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- a self-reported need of the youth for additional adult contacts
Who cannot join
- current or past regular use of illicit drugs
- repeated delinquent behaviour or single acts of violence against persons
- ongoing contacts with psychiatric care or social services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Effectiveness Trial of a One-to-one, Adult-to-youth Mentoring Program in Sweden
This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and exclusion of study participants are elaborated in collaboration with the providing NGO, and the program is given as customary.
- Conditions
- Substance Use
- Being tested
- Youth Mentoring program
- Keywords
- Youth mentoring, Effectiveness, Sweden, low-risk youth
- 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.
Youth Mentoring programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mentoring program | Experimental | Mentor and mentee meet at least every second week, for 2-4 h on every occasion, during 1 year (i.e., for a minimum of two school semesters). Meetings take place outside school and work hours, and the pairs choose activities of their own preferences. No monetary incentives exist, and the mentors are laymen volunteers. The program objective is to establish a safe and supportive relationship, by which the youth is assumed to benefit in social, emotional, and academic development, and as a consequence, be less prone to use alcohol and drugs. Receives: Behavioral: Youth Mentoring program |
| Control group | No intervention | No intervention provided, only brief phone calls to control for attention bias |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported substance use
Self-reported substance use among youth
Measured: One year
Secondary outcomes (1)
Youth delinquency
Self-reported delinquency among youth
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startOct 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden, Region Stockholm
- Responsible party
- Principal investigator, Maria Bodin, Karolinska Institutet
- 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
- NCT01138982
- Sponsor's protocol ID
- Dnr 238/2006:34
- Status last verified
- Mar 2016
- First submitted
- 7 Jun 2010
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Effectiveness Trial of a One-to-one, Adult-to-youth Mentoring Program in Sweden
- ClinicalTrials.gov ID
- NCT01138982
- Acronym / sponsor ID
- Dnr 238/2006:34
- Conditions
- Substance Use
- Keywords
- Youth mentoring, Effectiveness, Sweden, low-risk youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden, Region Stockholm
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Jun 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.
This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and exclusion of study participants are elaborated in collaboration with the providing NGO, and the program is given as customary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentoring program | Experimental | Behavioral: Youth Mentoring programMentor and mentee meet at least every second week, for 2-4 h on every occasion, during 1 year (i.e., for a minimum of two school semesters). Meetings take place outside school and work hours, and the pairs choose activities of their own preferences. No monetary incentives exist, and the mentors are laymen volunteers. The program objective is to establish a safe and supportive relationship, by which the youth is assumed to benefit in social, emotional, and academic development, and as a consequence, be less prone to use alcohol and drugs. |
| Control group | No intervention | –No intervention provided, only brief phone calls to control for attention bias |
Who may qualify
- Ages
- 14 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- a self-reported need of the youth for additional adult contacts
Key exclusion criteria (3 listed)
- current or past regular use of illicit drugs
- repeated delinquent behaviour or single acts of violence against persons
- ongoing contacts with psychiatric care or social services
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 |
|---|---|---|
| Youth Mentoring program | Behavioural | Mentoring program |
Primary outcome
Self-reported substance use
Time frame: One year
Self-reported substance use among youth
1 secondary outcome
Youth delinquency
Time frame: One year
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 8 Mar 2016.
- Individual participant dataSharing planned: No
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Healthy Volunteers
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 Youth Mentoring program in people with Substance Use, 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 1 inclusion and 3 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 8 Mar 2016. 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 substance use (time frame: One year). 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 8 Mar 2016.