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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00344474
Other study ID # PAJTXVA
Secondary ID 229/03
Status Completed
Phase Phase 2/Phase 3
First received June 22, 2006
Last updated June 24, 2011
Start date November 2003
Est. completion date July 2008

Study information

Verified date February 2006
Source King's College London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

Personality targeted cognitive behavioural interventions have been shown to be effective in reducing alcohol and drug misuse in adult substance abusers (Conrod et al., 2000) and adolescent drinkers (Conrod et al, in press). As these interventions target personality traits linked to risk for addictive and non-addictive mental disorders, the aim of this study is to examine the extent to which this approach can prevent and/or reduce alcohol and drug misuse as well as have an impact on the onset or severity of emotional and behavioural problems in young people.


Description:

Personality targeted cognitive behavioural interventions have been shown to be effective in reducing alcohol and drug misuse in adult substance abusers (Conrod et al., 2000) and adolescent drinkers (Conrod et al, in press). As these interventions target personality traits linked to risk for addictive and non-addictive psychopathology, the aim of this study is to examine the extent to which this approach is effective in preventing and/or reduce alcohol and drug misuse and concurrent psychiatric symptoms in young people.

Method: 875 Participants aged 13-16 years will be screened for personality risk in school-wide self-report assessments. Participants will be randomly assigned to a personality matched cognitive-behavioural intervention or a no-intervention control. The personality matched interventions will target four personality risk factors: negative thinking (NT), anxiety sensitivity (AS), impulsivity (IMP) and sensation seeking (SS). Outcome evaluation will occur 6, 12, 18 and 24 months post intervention. Primary outcomes will be time to onset and severity of alcohol and illicit substance use and misuse. Secondary outcome variables will include depressive symptoms, panic attack rates, reckless and antisocial behaviour. Secondary analyses involving genetic, cognitive and coping skills measures will examine moderators of treatment effects.

Hypotheses: It is expected that personality-targeted interventions will have personality-specific effects on aspects of addictive and non-addictive psychopathology to which each personality risk group is most susceptible.


Recruitment information / eligibility

Status Completed
Enrollment 710
Est. completion date July 2008
Est. primary completion date May 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 16 Years
Eligibility Inclusion Criteria:

- secondary school student

- scoring one standard deviation above the school mean on one of 4 personality dimensions.

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

Exclusion Criteria:

Study Design

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


Intervention

Behavioral:
PRE-Venture: Personality Risk Education
Motivational and Cognitive-Behavioural interventions targeting four personality risk factors for substance misuse. Two, 90-minute group sessions conducted at school with personality-matched peers and trained psychologists/councellors and co-facilitators.

Locations

Country Name City State
United Kingdom Institute of Psychiatry, King's College London London

Sponsors (2)

Lead Sponsor Collaborator
King's College London Action on Addiction

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Comeau N, Stewart SH, Loba P. The relations of trait anxiety, anxiety sensitivity, and sensation seeking to adolescents' motivations for alcohol, cigarette, and marijuana use. Addict Behav. 2001 Nov-Dec;26(6):803-25. — View Citation

Conrod PJ, Pihl RO, Stewart SH, Dongier M. Validation of a system of classifying female substance abusers on the basis of personality and motivational risk factors for substance abuse. Psychol Addict Behav. 2000 Sep;14(3):243-56. — View Citation

Conrod PJ, Stewart SH, Pihl RO, Côté S, Fontaine V, Dongier M. Efficacy of brief coping skills interventions that match different personality profiles of female substance abusers. Psychol Addict Behav. 2000 Sep;14(3):231-42. — View Citation

Stewart SH, Conrod PJ, Marlatt GA, Comeau MN, Thush C, Krank M. New developments in prevention and early intervention for alcohol abuse in youths. Alcohol Clin Exp Res. 2005 Feb;29(2):278-86. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to onset and severity of drug use time to illicit drug use events, assessed using the Reckless Behaviour Questionnaire 2 years No
Primary Frequency and Quantity of Drinking 2 years No
Primary Problem drinking symptoms Assessed using an abbreviated version of the Rutger's Alcohol Problem Index 2 years No
Secondary Psychiatric symptoms (depression, panic anxiety, antisocial behaviours), coping skills, motives for drinking Assessed using the Brief Symptom Inventory, the Reckless Behaviour Questionnaire, and the Drinking Motives Questionnaire. 2 years No
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