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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00776685
Other study ID # Adventure
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received October 17, 2008
Last updated June 24, 2011
Start date May 2007
Est. completion date May 2010

Study information

Verified date December 2010
Source King's College London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3190
Est. completion date May 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 16 Years
Eligibility Inclusion Criteria:

- Secondary school student

Exclusion Criteria:

Study Design

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


Intervention

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

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)

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. — View 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. — View Citation

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. — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years No
Primary Drinking frequency Past six months frequency of drinking 2 years No
Primary drinking quantity Average number of alcoholic beverages consumed on a typical drinking occasion in the past six months 2 years No
Primary Drinking problems number of drinking problems reported on an abbreviated version of the Rutger's Alcohol Problem Index. 2 years No
Primary illicit drug use events Time to onset of illicit drug use 2 years No
Secondary 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. 2 years No
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