Viewing Study NCT01656473



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Last Modification Date: 2024-10-26 @ 10:54 AM
Study NCT ID: NCT01656473
Status: COMPLETED
Last Update Posted: 2015-07-23
First Post: 2012-01-11

Brief Title: Evaluating the Effectiveness of Motivational Interviewing and a Dialectical Therapy Skills- Based Intervention for Youth
Sponsor: Centre for Addiction and Mental Health
Organization: Centre for Addiction and Mental Health

Study Overview

Official Title: CIHR Team in Innovations in Child and Youth Concurrent Disorders Service Delivery and Treatment Subproject
Status: COMPLETED
Status Verified Date: 2015-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 groupwill 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
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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None