- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01138982
Effectiveness Study of a Swedish Youth Mentoring Program
March 5, 2016 updated by: Maria Bodin, Karolinska Institutet
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden, 11435
- Mentor Sweden
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a self-reported need of the youth for additional adult contacts
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mentoring program
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.
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No Intervention: Control group
No intervention provided, only brief phone calls to control for attention bias
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported substance use
Time Frame: One year
|
Self-reported substance use among youth
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Youth delinquency
Time Frame: One year
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Self-reported delinquency among youth
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One year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria C Bodin, PhD, Centre for Psychiatry Research Stockholm, Karolinska Institutet/Stockholm County Council Health Care Provision
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
June 7, 2010
First Submitted That Met QC Criteria
June 7, 2010
First Posted (Estimate)
June 8, 2010
Study Record Updates
Last Update Posted (Estimate)
March 8, 2016
Last Update Submitted That Met QC Criteria
March 5, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 238/2006:34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.