Evaluating the Effectiveness of Motivational Interviewing and a Dialectical Therapy Skills- Based Intervention for Youth

This study is currently recruiting participants.
Verified November 2013 by Centre for Addiction and Mental Health
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Children's Hospital of Eastern Ontario
Children's Centre, Thunder Bay
Information provided by (Responsible Party):
Shelley McMain, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01656473
First received: January 11, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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:

  1. Youth with CD who receive an MI intervention will show increased motivation and readiness to change from pre to post MI intervention.
  2. 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.

Condition Intervention
Concurrent Disorders
Other: Motivational Interviewing and Dialectical Behaviour Therapy
Other: Motivational Interview plus Dialectical Behavior Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CIHR Team in Innovations in Child and Youth Concurrent Disorders: Service Delivery and Treatment Subproject

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • (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 ] [ Designated as safety issue: No ]
    Outcome measures to assess changes in mental health and substance use status.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-arm integrated intervention
Individual Motivational Interview session followed by 12-week DBT skills group
Other: Motivational Interviewing and Dialectical Behaviour Therapy
One individual session of MI followed by 12 weeks of DBT group skills training
Other Name: Integrated individual and group treatment
Other: Motivational Interview plus Dialectical Behavior Therapy
Individual Motivational Interview session plus 12-week DBT skills group

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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656473

Contacts
Contact: Nalayine Balarajan, B.A. 416-535-8501 ext 34919 nalayine.balarajan@camh.ca
Contact: Eliza Burroughs, M.A. 416-535-8501 ext 34919 eliza.burroughs@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5S 2S1
Contact: Nalayine Balarajan, B.A.    416-535-8501 ext 34919    nalayine.balarajan@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Children's Hospital of Eastern Ontario
Children's Centre, Thunder Bay
Investigators
Principal Investigator: Shelley McMain, PhD. Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Shelley McMain, Head, Personality Disorders Treatment, Research and Capacity Building, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01656473     History of Changes
Other Study ID Numbers: 069-2011
Study First Received: January 11, 2012
Last Updated: November 5, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Centre for Addiction and Mental Health:
Concurrent Disorders
Adolescents
Motivational Interviewing
Dialectical Behaviour Therapy
Caregiver Burden

ClinicalTrials.gov processed this record on April 22, 2014