AlcoholismREAL-SMARTNCT06262958
Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent
A study testing ASSIST and Treatment as usual in people with Alcoholism and Substance Abuse, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Substance Abuse, Alcohol Dependence
- What is being tested?
- ASSIST and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFinland
- Study dates
- 7 Aug 2017to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, 70110
Sanna Voutilainen, Res. nurse, +358447175351, sanna.voutilainen@kuh.fi
About this study
Official title: 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
Read the 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.
- Conditions
- Alcoholism, Substance Abuse, Alcohol Dependence, Alcohol-Related Disorders, Substance Use Disorders, Adolescent Behavior
- Being tested
- ASSIST, Treatment as usual
- Keywords
- alcohol, substance, abuse, mini-intervention, adolescent
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Alcohol-Related Disorders, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSISTBehavioural
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.
Treatment as usualOther
Psychotherapy and/or psychotropic drug treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Clients are receiving normal adolescent psychiatric care, mostly psychotherapy, medications, or both. Receives: Other: Treatment as usual |
| e-form of ASSIST alcohol and substance use mini-intervention | Experimental | 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. Receives: Behavioral: ASSIST; Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased consumption of alcohol, tobacco or substances
Decreased scores in ASSIST questionnaire
Measured: 6 months
Secondary outcomes (2)
BDI scores
Decreased scores in BDI questionnaire
Measured: 6 months
GAD scores
Decreased scores in GAD questionnaire
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 posted16 Feb 2024
- Study start7 Aug 2017
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tommi T Tolmunen, Docent, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262958
- Sponsor's protocol ID
- KUH5703459
- Acronym
- REAL-SMART
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06262958
- Acronym / sponsor ID
- REAL-SMART / KUH5703459
- Conditions
- Alcoholism, Substance Abuse, Alcohol Dependence, Alcohol-Related Disorders, Substance Use Disorders, Adolescent Behavior
- Keywords
- alcohol, substance, abuse, mini-intervention, adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 16 Feb 2024 (actual)
- 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.
ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Other: Treatment as usualClients are receiving normal adolescent psychiatric care, mostly psychotherapy, medications, or both. |
| e-form of ASSIST alcohol and substance use mini-intervention | Experimental | Behavioral: ASSIST, Other: Treatment as usualClients 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| ASSISTAdolescent 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. | Behavioural | e-form of ASSIST alcohol and substance use mini-intervention |
| Treatment as usualPsychotherapy and/or psychotropic drug treatment | Other | Treatment as usual, e-form of ASSIST alcohol and substance use mini-intervention |
Primary outcome
Decreased consumption of alcohol, tobacco or substances
Time frame: 6 months
Decreased scores in ASSIST questionnaire
2 secondary outcomes
BDI scores
Time frame: 6 months
GAD scores
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Tommi T Tolmunen, Docent principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSIST and Treatment as usual in people with Alcoholism and Substance Abuse, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 16 Feb 2024. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommi T Tolmunen, Docent (+358447172994, tommi.tolmunen@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased consumption of alcohol, tobacco or substances (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 16 Feb 2024.