- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01595568
Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3T 1C5
- Recruiting
- CHU Ste-Justine
-
Contact:
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Motive for psychiatric consultation
- Able to provide consent from parent/guardian for participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Learning to cope with your impulsivity
Cognitive-behavioural intervention targeting impulsive personality
|
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:
|
|
Experimental: Learning to cope with your sensation seeking
Cognitive behavioural intervention designed to help sensation seeking youth manage their need for stimulation and excitement.
|
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:
|
|
Experimental: Learning to cope with your anxiety sensitivity
Cognitive behavioural intervention teaching anxiety sensitive youth to manager their sensitivity to threat and anxiety.
|
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:
|
|
Experimental: Learning to manage your negative thinking
Cognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Binge drinking frequency
Time Frame: Baseline - 4months
|
Baseline - 4months
|
|
Change in Drinking frequency
Time Frame: Baseline - 4 months
|
Baseline - 4 months
|
|
Change in Drinking quantity
Time Frame: Baseline - 4 months
|
Baseline - 4 months
|
|
Change in Drinking problems
Time Frame: Baseline - 4 months
|
Baseline - 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline - 4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CER CHU Ste-Justine 3435
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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