Substance-Related DisordersNCT00694226
Brief Intervention in Substance Use in Adolescent Psychiatric Patients
A study testing brief motivational intervention and treatment as usual in people with Substance-Related Disorders, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The objective of the study was to assess the efficacy in decreasing the likelihood of substance use of a brief motivational enhancement intervention in adolescents referred to psychiatric treatment. 237 adolescents consecutively admitted to a psychiatry department completed an evaluation of their substance use. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- brief motivational intervention 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
- 143 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2004to Sep 2005
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects aged 12-17
- consecutively referred for psychiatric or psychological assessment and treatment to a Child and Adolescent Psychiatry and Psychology Department
Who cannot join
- Not willing to take part.
- Mentally retarded
- Non completion of a substantial part of the assessment protocol.
- Presenting severe acute psychopathological disturbances that interfere with the assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Intervention in Substance Use Among Adolescent Psychiatric Patients: A Randomized Controlled Trial
The objective of the study was to assess the efficacy in decreasing the likelihood of substance use of a brief motivational enhancement intervention in adolescents referred to psychiatric treatment.
237 adolescents consecutively admitted to a psychiatry department completed an evaluation of their substance use. Subjects identified as users were randomly allocated to one of two groups: an experimental group that received a brief intervention aimed at increasing their awareness of the risks of substance use, or a control group. All subjects received standard treatment according to the primary diagnosis. Structured questionnaires assessing knowledge, attitudes, perception of risks and intention of use of psychoactive substances were administered upon admission and 1 month later.
- Conditions
- Substance-Related Disorders
- Being tested
- brief motivational intervention, treatment as usual
- Keywords
- Adolescent, Substance use, Brief intervention, Child psychiatry
- 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.
brief motivational interventionBehavioural
Brief intervention, consisting in an intervention with the adolescent and a session with parents or mentors. The session with the adolescent lasted 60 minutes. Materials related to the interview were developed according to previous reports on the subject. After building a good rapport the interviewer involved the patient in an initial discussion about the results of the evaluation. This led to a review of the drugs used by the subject and an elicitation of positives and negatives of drug use. The relationship between drug use and current and long-term goals was explored. Discrepancies and problems in the future related to substance use were examined, and information and counseling was offered. The basic components of the motivational interview approach were contemplated, and several skills were used by the interviewers. The individual session with parents or mentors consisted in the presentation of educational materials and a brief counseling intervention on parenting skills.
treatment as usualBehavioural
Treatment as usual (TTU): After completion of the intervention, individuals and their families went on to receive standard care at the Child and Adolescent Psychiatry and Psychology Department according to the primary diagnosis.Individuals assigned to this group and their parents or tutors received standard care and no further intervention other than completion of the assessment protocol.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brief intervention, consisting in an intervention with the adolescent and a session with parents or mentors. The session with the adolescent lasted 60 minutes. Materials related to the interview were developed according to previous reports on the subject. After building a good rapport the interviewer involved the patient in an initial discussion about the results of the evaluation. This led to a review of the drugs used by the subject and an elicitation of positives and negatives of drug use. The relationship between drug use and current and long-term goals was explored. Discrepancies and problems in the future related to substance use were examined, and information and counseling was offered. The basic components of the motivational interview approach were contemplated, and several skills were used by the interviewers. The individual session with parents or mentors consisted in the presentation of educational materials and a brief counseling intervention on parenting skills. Receives: Behavioral: brief motivational intervention |
| 2 | Active comparator | Treatment as usual (TTU): Individuals assigned to this group and their parents or tutors received standard care and no further intervention other than completion of the assessment protocol. After completing the assessment individuals and their families went on to receive standard care at the Child and Adolescent Psychiatry and Psychology Department according to the primary diagnosis Receives: Behavioral: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes towards psychoactive substances (Knowledge, Risk perception, Problems and Intention of use) measured with questionnaires obtained from the Evaluation Instruments Bank (EIB), European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startMar 2004
- Primary completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694226
- Sponsor's protocol ID
- 1719/2003
- Status last verified
- Jun 2008
- First submitted
- 23 May 2008
- Last updated
- 10 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention in Substance Use Among Adolescent Psychiatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00694226
- Acronym / sponsor ID
- 1719/2003
- Conditions
- Substance-Related Disorders
- Keywords
- Adolescent, Substance use, Brief intervention, Child psychiatry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Ministry of Health, Spain
- Study start
- Mar 2004
- Primary completion
- Sep 2005 (actual)
- First posted
- 10 Jun 2008 (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 objective of the study was to assess the efficacy in decreasing the likelihood of substance use of a brief motivational enhancement intervention in adolescents referred to psychiatric treatment.
237 adolescents consecutively admitted to a psychiatry department completed an evaluation of their substance use. Subjects identified as users were randomly allocated to one of two groups: an experimental group that received a brief intervention aimed at increasing their awareness of the risks of substance use, or a control group. All subjects received standard treatment according to the primary diagnosis. Structured questionnaires assessing knowledge, attitudes, perception of risks and intention of use of psychoactive substances were administered upon admission and 1 month later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: brief motivational interventionBrief intervention, consisting in an intervention with the adolescent and a session with parents or mentors. The session with the adolescent lasted 60 minutes. Materials related to the interview were developed according to previous reports on the subject. After building a good rapport the interviewer involved the patient in an initial discussion about the results of the evaluation. This led to a review of the drugs used by the subject and an elicitation of positives and negatives of drug use. The relationship between drug use and current and long-term goals was explored. Discrepancies and problems in the future related to substance use were examined, and information and counseling was offered. The basic components of the motivational interview approach were contemplated, and several skills were used by the interviewers. The individual session with parents or mentors consisted in the presentation of educational materials and a brief counseling intervention on parenting skills. |
| 2 | Active comparator | Behavioral: treatment as usualTreatment as usual (TTU): Individuals assigned to this group and their parents or tutors received standard care and no further intervention other than completion of the assessment protocol. After completing the assessment individuals and their families went on to receive standard care at the Child and Adolescent Psychiatry and Psychology Department according to the primary diagnosis |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subjects aged 12-17
- consecutively referred for psychiatric or psychological assessment and treatment to a Child and Adolescent Psychiatry and Psychology Department
Key exclusion criteria (4 listed)
- Not willing to take part.
- Mentally retarded
- Non completion of a substantial part of the assessment protocol.
- Presenting severe acute psychopathological disturbances that interfere with the assessment.
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 |
|---|---|---|
| brief motivational interventionBrief intervention, consisting in an intervention with the adolescent and a session with parents or mentors. The session with the adolescent lasted 60 minutes. Materials related to the interview were developed according to previous reports on the subject. After building a good rapport the interviewer involved the patient in an initial discussion about the results of the evaluation. This led to a review of the drugs used by the subject and an elicitation of positives and negatives of drug use. The relationship between drug use and current and long-term goals was explored. Discrepancies and problems in the future related to substance use were examined, and information and counseling was offered. The basic components of the motivational interview approach were contemplated, and several skills were used by the interviewers. The individual session with parents or mentors consisted in the presentation of educational materials and a brief counseling intervention on parenting skills. | Behavioural | 1 |
| treatment as usualTreatment as usual (TTU): After completion of the intervention, individuals and their families went on to receive standard care at the Child and Adolescent Psychiatry and Psychology Department according to the primary diagnosis.Individuals assigned to this group and their parents or tutors received standard care and no further intervention other than completion of the assessment protocol. | Behavioural | 2 |
Primary outcome
Attitudes towards psychoactive substances (Knowledge, Risk perception, Problems and Intention of use) measured with questionnaires obtained from the Evaluation Instruments Bank (EIB), European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).
Time frame: 1 month
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 10 Jun 2008.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief motivational intervention and treatment as usual in people with Substance-Related Disorders, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 inclusion and 4 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 10 Jun 2008. 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 Spain. 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?
Attitudes towards psychoactive substances (Knowledge, Risk perception, Problems and Intention of use) measured with questionnaires obtained from the Evaluation Instruments Bank (EIB), European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). (time frame: 1 month). 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 10 Jun 2008.