Alcohol AbuseNCT01595568
Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population
A study testing Personality-targeted interventions in people with Alcohol Abuse and Drug Abuse, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
In adolescents, mental health problems are frequently associated with substance misuse, even considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to complicate the patient's treatment and prognosis by increasing, among others, substance use problems, reckless behaviours, relationships… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Alcohol Abuse, Drug Abuse, Mood Disorder
- What is being tested?
- Personality-targeted interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Jul 2012
- Phase
- Interventional
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Motive for psychiatric consultation
- Able to provide consent from parent/guardian for participation in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Ste-Justine
Montreal, Quebec, H3T 1C5
eveline.perrier-menard@umontreal.ca
About this study
In adolescents, mental health problems are frequently associated with substance misuse, even considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to complicate the patient's treatment and prognosis by increasing, among others, substance use problems, reckless behaviours, relationships and school problems and suicidal thoughts. It is therefore critical to invest time and effort into developing an efficient approach to prevent and reduce substance use problems and offer these children a more global and optimal treatment.
A brief personality-targeted intervention was developed with students of Canadian and English high schools based on four personality factors known to be implicated in the vulnerability to adolescent alcohol misuse (Impulsivity, Anxiety Sensitivity, Negative Thinking and Sensation Seeking) (Conrod et al., 2006,2008, O'Leary-Barrett 2010).
Read more
By helping the adolescents to develop better adaptive behaviours, this cognitive-behavioural intervention proved to reduce binge drinking, quantity and frequency of use and substance use problems (Conrod et al., 2006,2011).
The purpose of this study is to assess the impact of this intervention if combined to a regular treatment in a youth psychiatric population.
60 patients aged 14-17 years of a Child and Adolescent psychiatric department will be screened for personality risk with self-report assessments including the Substance Use Risk Profile Scale. Participants will be randomly assigned to a personality matched cognitive-behavioural intervention or a no-intervention control.
The main outcome measures of this study are alcohol and illicit drug outcomes. Secondary measures include mental health symptoms.
- Conditions
- Alcohol Abuse, Drug Abuse, Mood Disorder, Anxiety Disorder, Conduct Disorder
- Being tested
- Personality-targeted interventions
- Keywords
- Adolescents, Dual Diagnosis, Mental Disorders, Substance Use Problems, Prevention
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Mood Disorders, Anxiety Disorders, Conduct Disorder, Mental Disorders
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, Adventure
Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
Personality-targeted interventionsBehavioural
Also called Preventure, Adventure
Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
Personality-targeted interventionsBehavioural
Also called Preventure, Adventure
Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
Personality-targeted interventionsBehavioural
Also called Preventure, Adventure
Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
| Study group | Role | What they receive |
|---|---|---|
| Learning to cope with your impulsivity | Experimental | Cognitive-behavioural intervention targeting impulsive personality Receives: Behavioral: Personality-targeted interventions |
| Learning to cope with your sensation seeking | Experimental | Cognitive 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 sensitivity | Experimental | Cognitive behavioural intervention teaching anxiety sensitive youth to manager their sensitivity to threat and anxiety. Receives: Behavioral: Personality-targeted interventions |
| Learning to manage your negative thinking | Experimental | Cognitive 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.
Change in Binge drinking frequency
Measured: Baseline - 4months
Change in Drinking frequency
Measured: Baseline - 4 months
Change in Drinking quantity
Measured: Baseline - 4 months
Change in Drinking problems
Measured: Baseline - 4 months
Secondary outcomes (1)
Change in Emotional and behavioural problems
Psychiatric symptoms (depression, panic anxiety, antisocial behaviours), coping skills, motives for drinking, assessed using the Strengths and Difficulties Questionnaire, the Drinking Motives Questionnaire and the Brief Symptom Inventory.
Measured: Baseline - 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eveline Perrier-Ménard, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595568
- Sponsor's protocol ID
- CER CHU Ste-Justine 3435
- Status last verified
- Jul 2012
- First submitted
- 3 May 2012
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Reduction of Alcohol and Drug Problems in a Clinical Psychiatric Youth Population
- ClinicalTrials.gov ID
- NCT01595568
- Acronym / sponsor ID
- CER CHU Ste-Justine 3435
- Conditions
- Alcohol Abuse, Drug Abuse, Mood Disorder, Anxiety Disorder, Conduct Disorder
- Keywords
- Adolescents, Dual Diagnosis, Mental Disorders, Substance Use Problems, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (estimated)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In adolescents, mental health problems are frequently associated with substance misuse, even considered a risk factor for alcohol abuse and dependence. This dual diagnosis tends to complicate the patient's treatment and prognosis by increasing, among others, substance use problems, reckless behaviours, relationships and school problems and suicidal thoughts. It is therefore critical to invest time and effort into developing an efficient approach to prevent and reduce substance use problems and offer these children a more global and optimal treatment.
A brief personality-targeted intervention was developed with students of Canadian and English high schools based on four personality factors known to be implicated in the vulnerability to adolescent alcohol misuse (Impulsivity, Anxiety Sensitivity, Negative Thinking and Sensation Seeking) (Conrod et al., 2006,2008, O'Leary-Barrett 2010).
By helping the adolescents to develop better adaptive behaviours, this cognitive-behavioural intervention proved to reduce binge drinking, quantity and frequency of use and substance use problems (Conrod et al., 2006,2011).
The purpose of this study is to assess the impact of this intervention if combined to a regular treatment in a youth psychiatric population.
60 patients aged 14-17 years of a Child and Adolescent psychiatric department will be screened for personality risk with self-report assessments including the Substance Use Risk Profile Scale. Participants will be randomly assigned to a personality matched cognitive-behavioural intervention or a no-intervention control.
The main outcome measures of this study are alcohol and illicit drug outcomes. Secondary measures include mental health symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Learning to cope with your impulsivity | Experimental | Behavioral: Personality-targeted interventionsCognitive-behavioural intervention targeting impulsive personality |
| Learning to cope with your sensation seeking | Experimental | Behavioral: Personality-targeted interventionsCognitive behavioural intervention designed to help sensation seeking youth manage their need for stimulation and excitement. |
| Learning to cope with your anxiety sensitivity | Experimental | Behavioral: Personality-targeted interventionsCognitive behavioural intervention teaching anxiety sensitive youth to manager their sensitivity to threat and anxiety. |
| Learning to manage your negative thinking | Experimental | Behavioral: Personality-targeted interventionsCognitive behavioural intervention targeting pessimistic and negative thinking in hopeless youth |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Motive for psychiatric consultation
- Able to provide consent from parent/guardian for participation in the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personality-targeted interventionsAlso: Preventure, AdventureMotivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator | Behavioural | Learning to cope with your impulsivity |
| Personality-targeted interventionsAlso: Preventure, AdventureMotivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator | Behavioural | Learning to cope with your sensation seeking |
| Personality-targeted interventionsAlso: Preventure, AdventureMotivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator | Behavioural | Learning to cope with your anxiety sensitivity |
| Personality-targeted interventionsAlso: Preventure, AdventureMotivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator | Behavioural | Learning to manage your negative thinking |
Primary outcome
Change in Binge drinking frequency
Time frame: Baseline - 4months
Change in Drinking frequency
Time frame: Baseline - 4 months
Change in Drinking quantity
Time frame: Baseline - 4 months
Change in Drinking problems
Time frame: Baseline - 4 months
1 secondary outcome
Change in Emotional and behavioural problems
Time frame: Baseline - 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
Related trials for Alcohol Abuse
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Not yet recruiting
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Alcohol, Cannabis
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personality-targeted interventions in people with Alcohol Abuse and Drug Abuse, run by St. Justine's Hospital at 1 site in Canada.
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Jul 2012. 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 Canada. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eveline Perrier-Ménard, MD (514-345-4931 ext. 4050, eveline.perrier-menard@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Binge drinking frequency (time frame: Baseline - 4months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2012.