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Brief Intervention in Substance Use in Adolescent Psychiatric Patients

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ClinicalTrials.gov Identifier: NCT00694226
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : June 10, 2008
Sponsor:
Collaborator:
Ministry of Health, Spain
Information provided by:
Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE May 23, 2008
First Posted Date  ICMJE June 10, 2008
Last Update Posted Date June 10, 2008
Study Start Date  ICMJE March 2004
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Intervention in Substance Use in Adolescent Psychiatric Patients
Official Title  ICMJE Brief Intervention in Substance Use Among Adolescent Psychiatric Patients: A Randomized Controlled Trial
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Substance-Related Disorders
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: 1
    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.
    Intervention: Behavioral: brief motivational intervention
  • Active Comparator: 2
    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
    Intervention: Behavioral: treatment as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2008)
143
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694226
Other Study ID Numbers  ICMJE 1719/2003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Josefina Castro-Fornieles / Chief of the Child and Adolescent Psychiatry and Psychology departement, Hospital Clinic Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Ministry of Health, Spain
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP