- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262958
Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent (REAL-SMART)
February 8, 2024 updated by: Kuopio University Hospital
REAL-SMART: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence, REAL/Systemic Metabolic Alterations Related to Different Psychiatric Disease Categories in Adolescent
ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
All 14-20-year-old patients admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during 2017-2028 are requested to participate.
At admission (baseline), the patients are interviewed by the research nurse and asked to fill out questionnaires.
The interview includes a semi-structured diagnostic interview (SCID).
The participants are interviewed again in six months (follow-up), and the interview is identical to the one conducted in the admission phase.
Study Type
Interventional
Enrollment (Estimated)
800
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 Contact
- Name: Tommi T Tolmunen, Docent
- Phone Number: +358447172994
- Email: tommi.tolmunen@kuh.fi
Study Locations
-
-
-
Kuopio, Finland, 70110
- Recruiting
- Kuopio University Hospital
-
Contact:
- Sanna Voutilainen, Res. nurse
- Phone Number: +358447175351
- Email: sanna.voutilainen@kuh.fi
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria: Admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during the years 2016-2019
Exclusion Criteria: Unable to understand the questionnaires
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as usual
Clients are receiving normal adolescent psychiatric care, mostly psychotherapy, medications, or both.
|
Psychotherapy and/or psychotropic drug treatment
|
Experimental: e-form of ASSIST alcohol and substance use mini-intervention
Clients are receiving normal adolescent psychiatric care, mostly psychotherapy, medications, or both.
In addition to that, they will receive a mini-intervention for substance and alcohol use.
|
Psychotherapy and/or psychotropic drug treatment
Adolescent psychiatric outpatient will be offered an e-form of ASSIST alcohol and substance use mini-intervention.
Results will be compared to those who received TAU.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decreased consumption of alcohol, tobacco or substances
Time Frame: 6 months
|
Decreased scores in ASSIST questionnaire
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BDI scores
Time Frame: 6 months
|
Decreased scores in BDI questionnaire
|
6 months
|
GAD scores
Time Frame: 6 months
|
Decreased scores in GAD questionnaire
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tommi T Tolmunen, Docent, Professor
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 (Actual)
August 7, 2017
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Study Registration Dates
First Submitted
February 8, 2024
First Submitted That Met QC Criteria
February 8, 2024
First Posted (Actual)
February 16, 2024
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH5703459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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