NCT02540746

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

August 27, 2015

Last Update Submit

April 18, 2020

Conditions

Mental Disorders

Keywords

Emotional DysregulationEarly InterventionYouth Mental HealthStagingMotivational EnhancementFamily ConnectionsFamily Skills Training

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Emotion Regulation throughout 12-week ERG group, at post ERG group and 16-week follow-up to group.

    The Difficulties in Emotion Regulation Scales is a 36-item self-report measure of emotion dysregulation with adequate psychometric properties.

    Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST

Secondary Outcomes (18)

  • GAIN-Q3-MI-ONT

    Baseline (2 weeks pre-ERG ST) and post-treatment (week 12 of ERG-ST)

  • Sheehan Disability Scale

    Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST

  • Kessler Psychological Distress Scale (K-10)

    Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST

  • Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)

    Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST

  • The Depression Anxiety and Stress Scales 21 (DASS-21)

    Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST

  • +13 more secondary outcomes

Study Arms (4)

ERG Skills Training

EXPERIMENTAL

ERG Skills Training for 12 weeks

Behavioral: ERG Skills Training

ERG Skills Training + ME

EXPERIMENTAL

ERG Skills Training for 12 weeks preceded by Motivational Enhancement for 4 weeks

Behavioral: ERG Skills TrainingBehavioral: Motivational Enhancement

ERG Skills Training + FAM

EXPERIMENTAL

ERG Skills Training with concurrent 12-week Family Skills Training

Behavioral: ERG Skills TrainingBehavioral: Family Skills Training

ERG Skills Training + ME + FAM

EXPERIMENTAL

ERG Skills Training with concurrent 12-week Family Skills Training preceded by Motivational Enhancement for 4 weeks

Behavioral: ERG Skills TrainingBehavioral: Motivational EnhancementBehavioral: Family Skills Training

Interventions

ERG Skills TrainingBEHAVIORAL

Group-based Dialectical Behavior Therapy Skills Training for 12 weeks

ERG Skills TrainingERG Skills Training + FAMERG Skills Training + MEERG Skills Training + ME + FAM
Motivational EnhancementBEHAVIORAL

Three week Motivational Enhancement group

ERG Skills Training + MEERG Skills Training + ME + FAM
Family Skills TrainingBEHAVIORAL

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

Also known as: Family Connections
ERG Skills Training + FAMERG Skills Training + ME + FAM

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Help-seeking youth (ages 17-25 years)
  • Literacy in English
  • Early stage mental health concerns of mild to moderate severity
  • Emotional dysregulation

You may not qualify if:

  • Diagnosis of Borderline Personality Disorder
  • Diagnosis of Anorexia Nervosa or Bulimia Nervosa
  • Diagnosis of Posttraumatic Stress Disorder (current)
  • Moderate to Severe Depression (current)
  • Bipolar Disorder and related disorders
  • Diagnosis of Schizophrenia and other psychotic disorders
  • Diagnosis of Antisocial Personality Disorder (ASPD)
  • DSM-5 Substance Use disorder of Moderate or Severe severity (current)
  • Moderate to Severe Self-Harm behaviour within past year
  • Hospital admission for mental health concerns within past 6 months
  • Multiple (2+) Psychiatric Emergency Service visits within past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton - Youth Wellness Centre

Hamilton, Ontario, L8P4W6, Canada

Location

Related Publications (2)

  • McGorry PD, Purcell R, Hickie IB, Yung AR, Pantelis C, Jackson HJ. Clinical staging: a heuristic model for psychiatry and youth mental health. Med J Aust. 2007 Oct 1;187(S7):S40-2. doi: 10.5694/j.1326-5377.2007.tb01335.x.

    PMID: 17908024BACKGROUND

  • Soler J, Pascual JC, Tiana T, Cebria A, Barrachina J, Campins MJ, Gich I, Alvarez E, Perez V. Dialectical behaviour therapy skills training compared to standard group therapy in borderline personality disorder: a 3-month randomised controlled clinical trial. Behav Res Ther. 2009 May;47(5):353-8. doi: 10.1016/j.brat.2009.01.013. Epub 2009 Jan 29.

    PMID: 19246029BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Robert B Zipursky, MD

    St. Joseph's Healthcare Hamilton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 4, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)