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Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population

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ClinicalTrials.gov Identifier: NCT01595568
Recruitment Status : Unknown
Verified July 2012 by Eveline Perrier-Ménard, St. Justine's Hospital.
Recruitment status was:  Recruiting
First Posted : May 10, 2012
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):
Eveline Perrier-Ménard, St. Justine's Hospital

Tracking Information
First Submitted Date  ICMJE May 3, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date July 19, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Change in Binge drinking frequency [ Time Frame: Baseline - 4months ]
  • Change in Drinking frequency [ Time Frame: Baseline - 4 months ]
  • Change in Drinking quantity [ Time Frame: Baseline - 4 months ]
  • Change in Drinking problems [ Time Frame: Baseline - 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Change in Emotional and behavioural problems [ Time Frame: Baseline - 4 months ]
Psychiatric symptoms (depression, panic anxiety, antisocial behaviours), coping skills, motives for drinking, assessed using the Strengths and Difficulties Questionnaire, the Drinking Motives Questionnaire and the Brief Symptom Inventory.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population
Official Title  ICMJE Not Provided
Brief Summary

In adolescents, mental health problems are frequently associated with substance misuse, even considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to complicate the patient's treatment and prognosis by increasing, among others, substance use problems, reckless behaviours, relationships and school problems and suicidal thoughts. It is therefore critical to invest time and effort into developing an efficient approach to prevent and reduce substance use problems and offer these children a more global and optimal treatment.

A brief personality-targeted intervention was developed with students of Canadian and English high schools based on four personality factors known to be implicated in the vulnerability to adolescent alcohol misuse (Impulsivity, Anxiety Sensitivity, Negative Thinking and Sensation Seeking) (Conrod et al., 2006,2008, O'Leary-Barrett 2010).

By helping the adolescents to develop better adaptive behaviours, this cognitive-behavioural intervention proved to reduce binge drinking, quantity and frequency of use and substance use problems (Conrod et al., 2006,2011).

The purpose of this study is to assess the impact of this intervention if combined to a regular treatment in a youth psychiatric population.

60 patients aged 14-17 years of a Child and Adolescent psychiatric department will be screened for personality risk with self-report assessments including the Substance Use Risk Profile Scale. Participants will be randomly assigned to a personality matched cognitive-behavioural intervention or a no-intervention control.

The main outcome measures of this study are alcohol and illicit drug outcomes. Secondary measures include mental health symptoms.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Alcohol Abuse
  • Drug Abuse
  • Mood Disorder
  • Anxiety Disorder
  • Conduct Disorder
Intervention  ICMJE Behavioral: Personality-targeted interventions
Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
Other Names:
  • Preventure
  • Adventure
Study Arms  ICMJE
  • Experimental: Learning to cope with your impulsivity
    Cognitive-behavioural intervention targeting impulsive personality
    Intervention: Behavioral: Personality-targeted interventions
  • Experimental: Learning to cope with your sensation seeking
    Cognitive behavioural intervention designed to help sensation seeking youth manage their need for stimulation and excitement.
    Intervention: Behavioral: Personality-targeted interventions
  • Experimental: Learning to cope with your anxiety sensitivity
    Cognitive behavioural intervention teaching anxiety sensitive youth to manager their sensitivity to threat and anxiety.
    Intervention: Behavioral: Personality-targeted interventions
  • Experimental: Learning to manage your negative thinking
    Cognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth
    Intervention: Behavioral: Personality-targeted interventions
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Motive for psychiatric consultation
  • Able to provide consent from parent/guardian for participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595568
Other Study ID Numbers  ICMJE CER CHU Ste-Justine 3435
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eveline Perrier-Ménard, St. Justine's Hospital
Study Sponsor  ICMJE St. Justine's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Justine's Hospital
Verification Date July 2012

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