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Personality-targeted Interventions for Adolescent Alcohol Misuse (Preventure)

Primary Purpose

Alcohol Abuse, Drug Abuse, Depression

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
PRE-Venture: Personality Risk Education
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse focused on measuring Prevention, Addiction, Personality, Adolescents, Binge Drinking, Alcohol Abuse, Comorbidity, Depression, Anxiety, Antisocial Behaviour

Eligibility Criteria

13 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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: None

Sites / Locations

  • Institute of Psychiatry, King's College London

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

learning to cope with your impulsivity

learning to cope with your sensation seeking

learning to cope with your anxiety sensitivity

learning to manage your negative thinking

Arm Description

cognitive behavioural intervention teaching high impulsive youth how to manage their impulsive thinking and behaviours

cognitive-behavioural intervention teaching high sensation seeking youth how to manage their need for stimulation and excitement

cognitive behavioural intervention targeting catastrophic thinking in high anxiety sensitive youth

cognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth

Outcomes

Primary Outcome Measures

Time to onset and severity of drug use
time to illicit drug use events, assessed using the Reckless Behaviour Questionnaire
Frequency and Quantity of Drinking
Problem drinking symptoms
Assessed using an abbreviated version of the Rutger's Alcohol Problem Index

Secondary Outcome Measures

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.

Full Information

First Posted
June 22, 2006
Last Updated
June 24, 2011
Sponsor
King's College London
Collaborators
Action on Addiction
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1. Study Identification

Unique Protocol Identification Number
NCT00344474
Brief Title
Personality-targeted Interventions for Adolescent Alcohol Misuse
Acronym
Preventure
Official Title
A New School-based Drug Prevention Programme for Teenagers: Interventions That Target Personality Risk for Substance Abuse and Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
King's College London
Collaborators
Action on Addiction

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Drug Abuse, Depression, Panic Disorder, Conduct Disorder
Keywords
Prevention, Addiction, Personality, Adolescents, Binge Drinking, Alcohol Abuse, Comorbidity, Depression, Anxiety, Antisocial Behaviour

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
710 (Actual)

8. Arms, Groups, and Interventions

Arm Title
learning to cope with your impulsivity
Arm Type
Experimental
Arm Description
cognitive behavioural intervention teaching high impulsive youth how to manage their impulsive thinking and behaviours
Arm Title
learning to cope with your sensation seeking
Arm Type
Experimental
Arm Description
cognitive-behavioural intervention teaching high sensation seeking youth how to manage their need for stimulation and excitement
Arm Title
learning to cope with your anxiety sensitivity
Arm Type
Experimental
Arm Description
cognitive behavioural intervention targeting catastrophic thinking in high anxiety sensitive youth
Arm Title
learning to manage your negative thinking
Arm Type
Experimental
Arm Description
cognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth
Intervention Type
Behavioral
Intervention Name(s)
PRE-Venture: Personality Risk Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to onset and severity of drug use
Description
time to illicit drug use events, assessed using the Reckless Behaviour Questionnaire
Time Frame
2 years
Title
Frequency and Quantity of Drinking
Time Frame
2 years
Title
Problem drinking symptoms
Description
Assessed using an abbreviated version of the Rutger's Alcohol Problem Index
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Psychiatric symptoms (depression, panic anxiety, antisocial behaviours), coping skills, motives for drinking
Description
Assessed using the Brief Symptom Inventory, the Reckless Behaviour Questionnaire, and the Drinking Motives Questionnaire.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia J. Conrod, Ph.D.
Organizational Affiliation
Institute of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry, King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15714051
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. doi: 10.1097/01.alc.0000153547.34399.e8.
Results Reference
background
PubMed Identifier
10998950
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. doi: 10.1037//0893-164x.14.3.243.
Results Reference
background
PubMed Identifier
10998949
Citation
Conrod PJ, Stewart SH, Pihl RO, Cote 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. doi: 10.1037//0893-164x.14.3.231.
Results Reference
background
PubMed Identifier
11768546
Citation
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. doi: 10.1016/s0306-4603(01)00238-6.
Results Reference
background
PubMed Identifier
30865304
Citation
Edalati H, Afzali MH, Castellanos-Ryan N, Conrod PJ. The Effect of Contextual Risk Factors on the Effectiveness of Brief Personality-Targeted Interventions for Adolescent Alcohol Use and Misuse: A Cluster-Randomized Trial. Alcohol Clin Exp Res. 2019 May;43(5):997-1006. doi: 10.1111/acer.14016. Epub 2019 Apr 8.
Results Reference
derived
PubMed Identifier
20869813
Citation
Topper LR, Castellanos-Ryan N, Mackie C, Conrod PJ. Adolescent bullying victimisation and alcohol-related problem behaviour mediated by coping drinking motives over a 12 month period. Addict Behav. 2011 Jan-Feb;36(1-2):6-13. doi: 10.1016/j.addbeh.2010.08.016. Epub 2010 Sep 24.
Results Reference
derived
PubMed Identifier
20732631
Citation
O'Leary-Barrett M, Mackie CJ, Castellanos-Ryan N, Al-Khudhairy N, Conrod PJ. Personality-targeted interventions delay uptake of drinking and decrease risk of alcohol-related problems when delivered by teachers. J Am Acad Child Adolesc Psychiatry. 2010 Sep;49(9):954-963.e1. doi: 10.1016/j.jaac.2010.04.011. Epub 2010 Jul 31.
Results Reference
derived
PubMed Identifier
20048226
Citation
Conrod PJ, Castellanos-Ryan N, Strang J. Brief, personality-targeted coping skills interventions and survival as a non-drug user over a 2-year period during adolescence. Arch Gen Psychiatry. 2010 Jan;67(1):85-93. doi: 10.1001/archgenpsychiatry.2009.173.
Results Reference
derived

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Personality-targeted Interventions for Adolescent Alcohol Misuse

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