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Adventure: Teacher Delivered Personality-targeted Interventions for Substance Misuse (Adventure)

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ClinicalTrials.gov Identifier: NCT00776685
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Action on Addiction
Information provided by:
King's College London

Tracking Information
First Submitted Date  ICMJE October 17, 2008
First Posted Date  ICMJE October 21, 2008
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE May 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
  • Binge drinking frequency [ Time Frame: 2 years ]
    Frequency in the past 6 months that subject reported drinking 5 or more alcoholic beverages (4 or more for girls) on one drinking occasion.
  • Drinking frequency [ Time Frame: 2 years ]
    Past six months frequency of drinking
  • drinking quantity [ Time Frame: 2 years ]
    Average number of alcoholic beverages consumed on a typical drinking occasion in the past six months
  • Drinking problems [ Time Frame: 2 years ]
    number of drinking problems reported on an abbreviated version of the Rutger's Alcohol Problem Index.
  • illicit drug use events [ Time Frame: 2 years ]
    Time to onset of illicit drug use
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Time to onset and severity of alcohol and drug use and misuse [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
Emotional and behavioural problems, targeted and school-wide effects [ Time Frame: 2 years ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Psychiatric symptoms (depression, panic anxiety, antisocial behaviours), coping skills, motives for drinking [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adventure: Teacher Delivered Personality-targeted Interventions for Substance Misuse
Official Title  ICMJE Cognitive Behavioral Interventions That Target Personality Risk for Substance Abuse and Mental Illness: Delivery by Educational Professionals
Brief 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. 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Alcohol Abuse
  • Drug Abuse
  • Depression
  • Panic Disorder
  • Conduct Disorder
Intervention  ICMJE Behavioral: Personality-targeted interventions
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
Other Name: Preventure, but now delivered by teachers
Study Arms  ICMJE
  • Experimental: learning to cope with your impulsivity
    Cognitive-behavioural intervention targeting impulsive personality
    Intervention: Behavioral: Personality-targeted interventions
  • Experimental: learning to cope with your sensation seeking
    cognitive behavioural intervention designed to help sensation seeking youth manage their need for stimulation and excitement.
    Intervention: Behavioral: Personality-targeted interventions
  • Experimental: learning to cope with your anxiety sensitivity
    cognitive behavioural intervention teaching anxiety sensitive youth to manager their sensitivity to threat and anxiety.
    Intervention: Behavioral: Personality-targeted interventions
  • Experimental: learning to manage your negative thinking
    cognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth
    Intervention: Behavioral: Personality-targeted interventions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2008)
3190
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Secondary school student

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776685
Other Study ID Numbers  ICMJE Adventure
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Patricia Conrod, Institute of Psychiatry, King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE Action on Addiction
Investigators  ICMJE
Study Chair: Patricia J Conrod, PhD King's College London
PRS Account King's College London
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP