NCT01595568

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

May 3, 2012

Last Update Submit

July 18, 2012

Conditions

Keywords

AdolescentsDual DiagnosisMental DisordersSubstance Use ProblemsPrevention

Outcome Measures

Primary Outcomes (4)

  • Change in Binge drinking frequency

    Baseline - 4months

  • Change in Drinking frequency

    Baseline - 4 months

  • Change in Drinking quantity

    Baseline - 4 months

  • Change in Drinking problems

    Baseline - 4 months

Secondary Outcomes (1)

  • Change in Emotional and behavioural problems

    Baseline - 4 months

Study Arms (4)

Learning to cope with your impulsivity

EXPERIMENTAL

Cognitive-behavioural intervention targeting impulsive personality

Behavioral: Personality-targeted interventions

Learning to cope with your sensation seeking

EXPERIMENTAL

Cognitive behavioural intervention designed to help sensation seeking youth manage their need for stimulation and excitement.

Behavioral: Personality-targeted interventions

Learning to cope with your anxiety sensitivity

EXPERIMENTAL

Cognitive behavioural intervention teaching anxiety sensitive youth to manager their sensitivity to threat and anxiety.

Behavioral: Personality-targeted interventions

Learning to manage your negative thinking

EXPERIMENTAL

Cognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth

Behavioral: Personality-targeted interventions

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

Also known as: Preventure, Adventure
Learning to cope with your impulsivity

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Ste-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

MeSH Terms

Conditions

AlcoholismSubstance-Related DisordersMood DisordersAnxiety DisordersConduct DisorderMental Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Central Study Contacts

Eveline Perrier-Ménard, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Master student

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 10, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Last Updated

July 19, 2012

Record last verified: 2012-07

Locations