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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00694226
Other study ID # 1719/2003
Secondary ID
Status Completed
Phase N/A
First received May 23, 2008
Last updated June 9, 2008
Start date March 2004

Study information

Verified date June 2008
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics CommitteeSpain: Ministry of Health
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- Subjects aged 12-17

- consecutively referred for psychiatric or psychological assessment and treatment to a Child and Adolescent Psychiatry and Psychology Department

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
brief motivational intervention
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 usual
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.

Locations

Country Name City State
Spain Hospital Clinic Barcelona Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1 month No
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