- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01656473
Evaluating the Effectiveness of Motivational Interviewing and a Dialectical Therapy Skills- Based Intervention for Youth
CIHR Team in Innovations in Child and Youth Concurrent Disorders: Service Delivery and Treatment Subproject
The purpose of this study is to evaluate the preliminary effectiveness and feasibility of an integrated treatment approach for youth with concurrent disorders. The combined intervention will include individual sessions of Motivational Interviewing, followed by inclusion in a Dialectical Behaviour Therapy skills-based group.
The following main hypotheses will be examined:
- Youth with CD who receive an MI intervention will show increased motivation and readiness to change from pre to post MI intervention.
- Youth with CD who participate in a DBT intervention (orientation session followed by 12-week DBT skills training group)will show reductions in substance use and improvements in mental health, coping and affect regulation between pre to post treatment. The investigators expect that these treatment gains will be maintained at three-month follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For this study, the investigators want to treat adolescents with concurrent disorders. Eligible subjects will be invited to participate in the combined intervention described in detail below.
In order to determine eligibility, designated research staff will conduct a phone screen interview with interested youth (ages 14 - 18). Candidates will be asked questions about their current mental health and substance use status. Based on the information obtained in this interview, those youth who report co-occurring mental health and substance use problems will be asked to complete three internet-based self-report questionnaires using a designated link and unique identification numbers. Once the information from this assessment is collected and scored by research personnel, those candidates who meet the criteria for this study will be asked to participate in the remaining portion of the study. These subjects will be required to meet with the research assistant in person to complete a computer-based self-administered structured diagnostic interview and self-report questionnaires.
If eligible and interested, subjects will be asked to meet with a therapist for one individual session of MI. These sessions will assess subjects' readiness to engage in treatment, and help identify treatment goals and any barriers that may make treatment difficult.
After these sessions, subjects will be invited to attend a DBT-focused orientation prior to joining the 12-week skills group. The investigators expect to have approximately 8 youth in each group and each session will run for 2 hours, weekly. The purpose of these group sessions is to learn skills that will help subjects cope in healthier ways. The following skills will be taught: (1) interpersonal effectiveness; (2) emotion regulation; (3) distress tolerance: and (4) mindfulness. The use of skills will be geared to addressing substance use problems and other mental health issues (e.g. anxiety, depression, self-harm, etc.).
Participants will be asked to complete questionnaires at the following time-points: screening, baseline, post-MI (2 weeks), mid-DBT (8 weeks), post-DBT (14 weeks), and at 14 weeks follow-up. Participants will be offered financial compensation upon completion of each assessment package.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- age 14 to 18 years (inclusive);
- literacy in English;
- significant substance abuse problems indicated by a score in the problematic range on either the AUDIT (4 or above) or the DAST-A (6 or above);
- significant mental health problems as indicated by a score in the clinical range on at least one subscale of the YSR (T-score 65 or over);
- informed consent to participate in study;
- participation in regular case management or counselling (at least twice per month)1.
Exclusion criteria:
- history of schizophrenia or other psychotic disorder,
- evidence of an organic brain syndrome or severe intellectual disability;
- family members who are participating in the family intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MI and DBT
Individual Motivational Interview session followed by 12-week Dialectical Behaviour Therapy skills group
|
One individual session of Motivational Interview followed by 12 weeks of Dialectical Behaviour Therapy group skills training
Other Names:
Individual Motivational Interview session plus 12-week Dialectical Behaviour Therapy skills group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(1) Substance Use: Teen Addiction Severity Index and; (2) Mental Health Symptoms: Youth Self-Report
Time Frame: Change from Baseline in Teen Addiction Severity Index and Youth Self-report at 2weeks, 8 weeks, 14 weeks, and 28 weeks
|
Outcome measures to assess changes in mental health and substance use status.
|
Change from Baseline in Teen Addiction Severity Index and Youth Self-report at 2weeks, 8 weeks, 14 weeks, and 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
University of Rhode Island Change Assessment; Rutger's Alcohol Problem Index; Social Adjustment Scale-Adolescent Report; Difficulties in Emotion Regulation; Centre for Epidemiologic Studies in Depression
Time Frame: Change from Baseline in University of Rhode Island Change Assessment, Rutger's Alcohol Problem Index, Difficulties in Emotion Regulation, Social Adjustment Scale-Adolescent Report, Centre for Epidemiologic Studies in Depression at 2, 8, 14, and 28weeks
|
In addition to outcome measurements for youth participants, adult caregivers will also be asked to complete two outcome measures: Stress Index of Parents of Adolescents; Child Behavior Checklist
|
Change from Baseline in University of Rhode Island Change Assessment, Rutger's Alcohol Problem Index, Difficulties in Emotion Regulation, Social Adjustment Scale-Adolescent Report, Centre for Epidemiologic Studies in Depression at 2, 8, 14, and 28weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shelley McMain, PhD., Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 069-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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