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Alcohol AbusePhase 2/3PreventureNCT00344474

Personality-targeted Interventions for Adolescent Alcohol Misuse

A Phase 2/3 study testing PRE-Venture: Personality Risk Education in people with Alcohol Abuse and Drug Abuse, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 13 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Abuse, Drug Abuse, Depression
What is being tested?
PRE-Venture: Personality Risk Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
710 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2003to Jul 2008
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Institute of Psychiatry, King's College London

    London, SE5 8AF

Other trials in United Kingdom

About this study

Official title: A New School-based Drug Prevention Programme for Teenagers: Interventions That Target Personality Risk for Substance Abuse and Mental Illness

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.

Read the 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.

Being tested
PRE-Venture: Personality Risk Education
Keywords
Prevention, Addiction, Personality, Adolescents, Binge Drinking, Alcohol Abuse, Comorbidity, Depression, Anxiety, Antisocial Behaviour
Medical subject headings
Alcoholism, Substance-Related Disorders, Depression, Panic Disorder, Conduct Disorder, Behavior, Addictive, Binge Drinking, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRE-Venture: Personality Risk EducationBehavioural

    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.

Study groups in NCT00344474
Study groupRoleWhat they receive
learning to cope with your impulsivityExperimentalcognitive behavioural intervention teaching high impulsive youth how to manage their impulsive thinking and behaviours
Receives: Behavioral: PRE-Venture: Personality Risk Education
learning to cope with your sensation seekingExperimentalcognitive-behavioural intervention teaching high sensation seeking youth how to manage their need for stimulation and excitement
Receives: Behavioral: PRE-Venture: Personality Risk Education
learning to cope with your anxiety sensitivityExperimentalcognitive behavioural intervention targeting catastrophic thinking in high anxiety sensitive youth
Receives: Behavioral: PRE-Venture: Personality Risk Education
learning to manage your negative thinkingExperimentalcognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth
Receives: Behavioral: PRE-Venture: Personality Risk Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to onset and severity of drug use

    time to illicit drug use events, assessed using the Reckless Behaviour Questionnaire

    Measured: 2 years

  2. Frequency and Quantity of Drinking

    Measured: 2 years

  3. Problem drinking symptoms

    Assessed using an abbreviated version of the Rutger's Alcohol Problem Index

    Measured: 2 years

Secondary outcomes (1)

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2006 (estimated)
  2. Study startNov 2003
  3. Primary completionMay 2006
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00344474
Sponsor's protocol ID
PAJTXVA
Other IDs
229/03
Acronym
Preventure
Status last verified
Feb 2006
First submitted
22 Jun 2006
Last updated
27 Jun 2011
Results posted
No

Publications

  • 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.

    PubMed 15714051

  • 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.

    PubMed 10998950

  • 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.

    PubMed 10998949

  • 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.

    PubMed 11768546

  • 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.

    PubMed 30865304

  • 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.

    PubMed 20869813

  • 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.

    PubMed 20732631

  • 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.

    PubMed 20048226

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PRE-Venture: Personality Risk Education in people with Alcohol Abuse and Drug Abuse, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to onset and severity of drug use (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00344474, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011; AzTrials last refreshed its copy on 31 Oct 2026.

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