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Alcohol AbusePhase 2/3AdventureNCT00776685

Adventure: Teacher Delivered Personality-targeted Interventions for Substance Misuse

A Phase 2/3 study testing Personality-targeted interventions 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

Several personality factors have been shown to be associated with risk for alcohol and substance misuse, and differentiate substance abusers based on clinical profile, treatment response and susceptibility to other forms of mental illness. 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?
Personality-targeted interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,190 participants
Where
1 siteUnited Kingdom
Study dates
May 2007to May 2010
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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Institute of Psychiatry, King's College London

    London

Other trials in United Kingdom

About this study

Official title: Cognitive Behavioral Interventions That Target Personality Risk for Substance Abuse and Mental Illness: Delivery by Educational Professionals

Several personality factors have been shown to be associated with risk for alcohol and substance misuse, and differentiate substance abusers based on clinical profile, treatment response and susceptibility to other forms of mental illness. Personality-targeted interventions have been found to have significant preventative effects on onset and growth of drinking, binge-drinking and drinking problems in adolescents attending mainstream schools (Conrod, Castellanos \& Mackie, 2008). The interventions concurrently reduced personality-specific emotional and behavioural problems (Castellanos \& Conrod, 2006), and prevented the onset and escalation of drug-use over a two-year period (Conrod, Castellanos-Ryan \& Strang, 2010). This cluster randomised controlled trial aims to examine whether these results can be replicated when interventions are delivered by trained educational professionals. In addition, the trial will evaluate the broader impact of the programme on cigarette smoking, school attendance, academic achievement and school-wide behaviours.

Read the detailed description

The Adventure study aims to examine whether educational professionals such as teachers, mentors or individuals in a pastoral role, who are trained in carrying out personality-targeted interventions will be effective in reducing problem behaviours in a group of adolescents.

20 schools in London, U.K. were recruited for the trial, and over 2000 adolescents (mean age 13.7 years) consented to participate in the survey and intervention phases of the trial. Schools were randomly assigned to control or intervention condition, and students in intervention schools who met the criteria for any of the 4 personality risk subscales of the Substance Use Risk Profile Scale (Negative Thinking, Anxiety Sensitivity, Sensation Seeking and Impulsivity) were invited to participate in a personality-targeted intervention by trained members of staff from their schools. All participants were invited to complete follow-up surveys at 6-month intervals for 2 years. The remaining 55% of low risk students in the grad were also followed to examine population-level effects of the intervention as well.

The main outcome measures of this RCT are alcohol and illicit drug outcomes. Secondary measures include mental health symptoms, risky behaviour, school attainment and attendance, and school-wide behaviours.

It is hypothesised that teacher-delivered personality-targeted interventions will have similar preventative effects on alcohol and drug use as reported by Conrod et al (2008, 2010), in addition to the personality-specific intervention effects reported by Castellanos \& Conrod (2006). In addition, broader effects of the intervention on academic achievement and school-wide behaviour will be examined in this trial, both at the individual level and at the population-level.

Being tested
Personality-targeted interventions
Medical subject headings
Alcoholism, Substance-Related Disorders, Depression, Panic Disorder, Conduct Disorder

What participants receive

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

  • Personality-targeted interventionsBehavioural

    Also called Preventure, but now delivered by teachers

    Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained teacher and co-facilitator

Study groups in NCT00776685
Study groupRoleWhat they receive
learning to cope with your impulsivityExperimentalCognitive-behavioural intervention targeting impulsive personality
Receives: Behavioral: Personality-targeted interventions
learning to cope with your sensation seekingExperimentalcognitive behavioural intervention designed to help sensation seeking youth manage their need for stimulation and excitement.
Receives: Behavioral: Personality-targeted interventions
learning to cope with your anxiety sensitivityExperimentalcognitive behavioural intervention teaching anxiety sensitive youth to manager their sensitivity to threat and anxiety.
Receives: Behavioral: Personality-targeted interventions
learning to manage your negative thinkingExperimentalcognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth
Receives: Behavioral: Personality-targeted interventions

What is being measured

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

  1. Binge drinking frequency

    Frequency in the past 6 months that subject reported drinking 5 or more alcoholic beverages (4 or more for girls) on one drinking occasion.

    Measured: 2 years

  2. Drinking frequency

    Past six months frequency of drinking

    Measured: 2 years

  3. drinking quantity

    Average number of alcoholic beverages consumed on a typical drinking occasion in the past six months

    Measured: 2 years

  4. Drinking problems

    number of drinking problems reported on an abbreviated version of the Rutger's Alcohol Problem Index.

    Measured: 2 years

  5. illicit drug use events

    Time to onset of illicit drug use

    Measured: 2 years

Secondary outcomes (1)

  1. Emotional and behavioural problems, targeted and school-wide effects

    Psychiatric symptoms (depression, panic anxiety, antisocial behaviours), coping skills, motives for drinking, school attendance and attainment, in-class behaviours assessed using the Strengths and Difficulties Questionnaire and the Brief Symptom Inventory.

    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 posted21 Oct 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionMar 2010
  4. Study completionMay 2010

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
3,190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00776685
Sponsor's protocol ID
Adventure
Acronym
Adventure
Status last verified
Dec 2010
First submitted
17 Oct 2008
Last updated
27 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • Conrod PJ, Castellanos N, Mackie C. Personality-targeted interventions delay the growth of adolescent drinking and binge drinking. J Child Psychol Psychiatry. 2008 Feb;49(2):181-90. doi: 10.1111/j.1469-7610.2007.01826.x.

    PubMed 18211277

  • Conrod PJ, Stewart SH, Comeau N, Maclean AM. Efficacy of cognitive-behavioral interventions targeting personality risk factors for youth alcohol misuse. J Clin Child Adolesc Psychol. 2006 Dec;35(4):550-63. doi: 10.1207/s15374424jccp3504_6.

    PubMed 17007600

  • 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

  • O'Leary-Barrett M, Castellanos-Ryan N, Pihl RO, Conrod PJ. Mechanisms of personality-targeted intervention effects on adolescent alcohol misuse, internalizing and externalizing symptoms. J Consult Clin Psychol. 2016 May;84(5):438-52. doi: 10.1037/ccp0000082. Epub 2016 Feb 15.

    PubMed 26881449

  • Mahu IT, Doucet C, O'Leary-Barrett M, Conrod PJ. Can cannabis use be prevented by targeting personality risk in schools? Twenty-four-month outcome of the adventure trial on cannabis use: a cluster-randomized controlled trial. Addiction. 2015 Oct;110(10):1625-33. doi: 10.1111/add.12991. Epub 2015 Jul 14.

    PubMed 26011508

  • Conrod PJ, O'Leary-Barrett M, Newton N, Topper L, Castellanos-Ryan N, Mackie C, Girard A. Effectiveness of a selective, personality-targeted prevention program for adolescent alcohol use and misuse: a cluster randomized controlled trial. JAMA Psychiatry. 2013 Mar;70(3):334-42. doi: 10.1001/jamapsychiatry.2013.651.

    PubMed 23344135

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Personality-targeted interventions 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 1 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?

Binge drinking frequency (time frame: 2 years). The study lists 5 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 NCT00776685, which also lists 7 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.

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