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

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

Tracking Information

• First Submitted Date: May 3, 2012
• First Posted Date: May 10, 2012
• Last Update Posted Date: July 19, 2012
• Study Start Date: February 2012
• Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Alcohol Abuse
• Drug Abuse
• Mood Disorder
• Anxiety Disorder
• Conduct Disorder

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 8, 2012): 60
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Motive for psychiatric consultation
• Able to provide consent from parent/guardian for participation in the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01595568
• Other Study ID Numbers: CER CHU Ste-Justine 3435
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Eveline Perrier-Ménard, St. Justine's Hospital
• Study Sponsor: St. Justine's Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: St. Justine's Hospital
• Verification Date: July 2012