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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01595568
Other study ID # CER CHU Ste-Justine 3435
Secondary ID
Status Recruiting
Phase N/A
First received May 3, 2012
Last updated July 18, 2012
Start date February 2012

Study information

Verified date July 2012
Source St. Justine's Hospital
Contact Eveline Perrier-Ménard, MD
Phone 514-345-4931
Email eveline.perrier-menard@umontreal.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria:

- Motive for psychiatric consultation

- Able to provide consent from parent/guardian for participation in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


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
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
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
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

Locations

Country Name City State
Canada CHU Ste-Justine Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Binge drinking frequency Baseline - 4months No
Primary Change in Drinking frequency Baseline - 4 months No
Primary Change in Drinking quantity Baseline - 4 months No
Primary Change in Drinking problems Baseline - 4 months No
Secondary Change in Emotional and behavioural problems 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. Baseline - 4 months No
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