Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth

Summary

The aim of this pilot study is to examine a brief manualized treatment, Emotional Regulation Group Skills Training (ERG ST), which has shown promise with high-risk youth presenting with a range of mental health concerns. The investigators will examine the effectiveness of a ERG ST group, as well as two additional components to which clients will be randomized: a motivational enhancement (ME) pre-treatment, and family skills treatment (FAM). This project will be the first to combine and test these modules as a transdiagnostic early intervention for youth in the early stages on mental illness. This pilot trial will answer the following questions: 1) What is the response rate to ERG ST compared to ERG ST plus FAM, and who benefits? 2) What is the response rate to a ME pre-treatment, and who benefits? 3) What is the acceptability of this treatment?

The ME pre-treatment will consist of four weekly one and a half hour sessions. The 12-week ERG ST will consist of 12 weekly two-hour sessions with 4-12 youths per group. The 12-week FAM will consist of 12 weekly two-hour sessions, with 16-20 caregivers per group. This study will use a two-stage randomization design to allow for balanced groups if there is differential attrition after pre-treatment. The following are the four treatment combinations: ERG ST; ERG ST+FAM; ME+ERG ST; ME+ERG ST+FAM. Four subjects will be enrolled in the study and randomized. The primary outcome is to improve emotion dysregulation in participants. Emotion dysregulation will be measured using the Difficulties in Emotion Regulation Scales (DERS).

Conditions

• Mental Disorders

Interventions

BEHAVIORAL

ERG Skills Training

Group-based Dialectical Behavior Therapy Skills Training for 12 weeks

BEHAVIORAL

Motivational Enhancement

Three week Motivational Enhancement group

BEHAVIORAL

Family Skills Training

12-week group-based family skills training using Family Connections model

Sponsors & Collaborators

• Hamilton Academic Health Sciences Organization

  collaborator OTHER

• St. Joseph's Healthcare Hamilton

  lead OTHER

Principal Investigators

• Robert B Zipursky, MD · St. Joseph's Healthcare Hamilton

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

17 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Canada

Study Locations