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Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth

Primary Purpose

Mental Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ERG Skills Training
Motivational Enhancement
Family Skills Training
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Emotional Dysregulation, Early Intervention, Youth Mental Health, Staging, Motivational Enhancement, Family Connections, Family Skills Training

Eligibility Criteria

17 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton - Youth Wellness Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

ERG Skills Training

ERG Skills Training + ME

ERG Skills Training + FAM

ERG Skills Training + ME + FAM

Arm Description

ERG Skills Training for 12 weeks

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

ERG Skills Training with concurrent 12-week Family Skills Training

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

GAIN-Q3-MI-ONT
The GAIN-Q3-MI-ONT includes the following scales: School Problems, Work Problems, Health Problems, Sources of Stress, Risk Behaviours, Internalizing Disorders, Externalizing Disorders, Substance Disorders, Crime & Violence and Total Disorder. For most individual screeners, internal consistency is good to excellent (alpha > .7) for adolescents and adults.
Sheehan Disability Scale
Functioning will be measured using the Sheehan Disability Scale, a self-report measure of functioning in: home, work/school, and the social realm.
Kessler Psychological Distress Scale (K-10)
Psychological distress will be measured using the K-10, a brief and well-validated instrument.
Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)
The DBT-WCCL which has adequate validity and reliability, will be used as a measure of coping skills.
The Depression Anxiety and Stress Scales 21 (DASS-21)
The Depression Anxiety and Stress Scales 21 (DASS-21) is a 21-item short-form measure of depression, anxiety and stress. Reliability, measured using Cronbach's alpha, has been shown to be adequate: alpha = .93 for the total scale. The DASS-21 has shown good convergent and discriminant validity when compared with other measures of depression and anxiety.
Burden Assessment Scale
The Burden Assessment Scale, which assesses levels of objective and subjective burden, and the Perceived Burden Scale, which assesses interpersonal burden and role strain, will be used as a measure of caregiver burden.
Modified M.I.N.I. Screener (MMS)
The MMS is designed to identify people who need a mental health assessment, covering mood disorders, anxiety and psychotic disorders.
Lifetime Suicide Attempt Self Injury (L-SASI)
The L-SASI is an interview to collect lifetime history details of non-suicidal self-injury and suicidal behaviour. The interview will be used to exclude individuals who have had moderate to severe self-harm within the past year.
The International Personality Disorder Examination (IPDE)
This measure will be used to determine a probable or negative diagnosis of BPD in order to support the diagnosis of BPD exclusion criteria.
Patient Health Questionnaire (PHQ)
A diagnostic tool that will be used as a screener for depression, anxiety, eating disorders and alcohol use.
Readiness for Change
Participants will indicate their readiness to engage in treatment using the Readiness for Change questionnaire which was derived directly from the GAIN-Q3.
Validating and Invalidating Response Scale (VIRS-kids)
VIRS-kids is a measure of how much a caregiver's validation and invalidation impacts a youth's emotional regulation, behavior and care giver-youth relationship satisfaction.
The M.I.N.I. International Neuropsychiatric Interview
This is a brief structured interview for the major psychiatric disorders in the DSM. It assesses for: major depressive episode, suicidality, manic episode, bipolar disorders, panic disorder, agoraphobia, social phobia, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, substance use and dependence, psychotic disorders, anorexia nervosa, bulimia nervosa, generalized anxiety disorder. The M.I.N.I. will be used to ensure that exclusion criteria are not being met.
Borderline Symptom List 23 (BSL-23)
The BSL-23 will be used to screen for Borderline Personality Disorder (BPD) symptoms and self-harm behaviours.
Brief Treatment History Interview (B-THI)
A selection of questions from the B-THI that contains face-valid questions will be used to assess for hospitalization and psychiatric emergency use, psychotropic medication and receipt of ancillary psychotherapy.
Family Assessment Device (FAD)
FAD is a 53 item self-report measure designed to measure family function (31). The FAD is made up of seven scales which measure Problem Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behaviour Control and General Functioning. The reliability, measured using Cronbach's alpha, ranged from 0.72 (Roles and Behaviour Control) to 0.92 (General Functioning).
Texas Grief Inventory
The Texas Grief Inventory, which has three subscales: grief (15 items), mastery (15 items) and empowerment (19 items), will be used to measure caregivers' sense of empowerment.
Adult Behaviour Checklist (ABCL)
The Adult Behaviour Checklist for ages 18-59 (ABCL) is a checklist used to obtain information on a range of mental health and substance use concerns. The family/friends will report on the youth's difficulties. Authors report internal consistency alphas ranging from 0.78 to 0.85 and test-retest reliability ranging from r = 0.73-0.92.

Full Information

First Posted
August 27, 2015
Last Updated
April 18, 2020
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Hamilton Academic Health Sciences Organization
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1. Study Identification

Unique Protocol Identification Number
NCT02540746
Brief Title
Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth
Official Title
Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
Hamilton Academic Health Sciences Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
The goal of this pilot study was to carry out a randomized controlled trial to investigate whether motivational enhancement therapy (MET) improved the treatment effects of a 12-week psychological intervention, Dialectical Behaviour Therapy Skills Training (DBT-ST), for EA presenting in the early stages of mental health difficulties. Participants were recruited from the Youth Wellness Centre at St. Joseph's Healthcare Hamilton and McMaster University's Student Wellness Centre in Hamilton, Canada. Methods: Seventy-five participants were randomized to receive MET followed by DBT-ST or to DBT-ST alone. We assessed psychological distress, emotion dysregulation, and depression and anxiety symptoms as outcomes. Results: We found that both treatment groups had significant reductions in emotional dysregulation, psychological distress, depression, and anxiety at post- treatment and at the 3-month follow-up. Participants assigned to MET pre-treatment experienced greater improvement in psychological distress at the end of treatment. Conclusion: This pilot study provides preliminary evidence of the potential augmentation of DBT-ST using MET in a real-world setting. Future studies should examine whether MET uniquely augments DBT-ST through the use of a comparable pre-treatment control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Emotional Dysregulation, Early Intervention, Youth Mental Health, Staging, Motivational Enhancement, Family Connections, Family Skills Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERG Skills Training
Arm Type
Experimental
Arm Description
ERG Skills Training for 12 weeks
Arm Title
ERG Skills Training + ME
Arm Type
Experimental
Arm Description
ERG Skills Training for 12 weeks preceded by Motivational Enhancement for 4 weeks
Arm Title
ERG Skills Training + FAM
Arm Type
Experimental
Arm Description
ERG Skills Training with concurrent 12-week Family Skills Training
Arm Title
ERG Skills Training + ME + FAM
Arm Type
Experimental
Arm Description
ERG Skills Training with concurrent 12-week Family Skills Training preceded by Motivational Enhancement for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
ERG Skills Training
Intervention Description
Group-based Dialectical Behavior Therapy Skills Training for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement
Intervention Description
Three week Motivational Enhancement group
Intervention Type
Behavioral
Intervention Name(s)
Family Skills Training
Other Intervention Name(s)
Family Connections
Intervention Description
12-week group-based family skills training using Family Connections model
Primary Outcome Measure Information:
Title
Change from Baseline in Emotion Regulation throughout 12-week ERG group, at post ERG group and 16-week follow-up to group.
Description
The Difficulties in Emotion Regulation Scales is a 36-item self-report measure of emotion dysregulation with adequate psychometric properties.
Time Frame
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 Outcome Measure Information:
Title
GAIN-Q3-MI-ONT
Description
The GAIN-Q3-MI-ONT includes the following scales: School Problems, Work Problems, Health Problems, Sources of Stress, Risk Behaviours, Internalizing Disorders, Externalizing Disorders, Substance Disorders, Crime & Violence and Total Disorder. For most individual screeners, internal consistency is good to excellent (alpha > .7) for adolescents and adults.
Time Frame
Baseline (2 weeks pre-ERG ST) and post-treatment (week 12 of ERG-ST)
Title
Sheehan Disability Scale
Description
Functioning will be measured using the Sheehan Disability Scale, a self-report measure of functioning in: home, work/school, and the social realm.
Time Frame
Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Kessler Psychological Distress Scale (K-10)
Description
Psychological distress will be measured using the K-10, a brief and well-validated instrument.
Time Frame
Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)
Description
The DBT-WCCL which has adequate validity and reliability, will be used as a measure of coping skills.
Time Frame
Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
Title
The Depression Anxiety and Stress Scales 21 (DASS-21)
Description
The Depression Anxiety and Stress Scales 21 (DASS-21) is a 21-item short-form measure of depression, anxiety and stress. Reliability, measured using Cronbach's alpha, has been shown to be adequate: alpha = .93 for the total scale. The DASS-21 has shown good convergent and discriminant validity when compared with other measures of depression and anxiety.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Burden Assessment Scale
Description
The Burden Assessment Scale, which assesses levels of objective and subjective burden, and the Perceived Burden Scale, which assesses interpersonal burden and role strain, will be used as a measure of caregiver burden.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Modified M.I.N.I. Screener (MMS)
Description
The MMS is designed to identify people who need a mental health assessment, covering mood disorders, anxiety and psychotic disorders.
Time Frame
Baseline (2 weeks pre-ERG ST)
Title
Lifetime Suicide Attempt Self Injury (L-SASI)
Description
The L-SASI is an interview to collect lifetime history details of non-suicidal self-injury and suicidal behaviour. The interview will be used to exclude individuals who have had moderate to severe self-harm within the past year.
Time Frame
Baseline (2 weeks pre-ERG ST)
Title
The International Personality Disorder Examination (IPDE)
Description
This measure will be used to determine a probable or negative diagnosis of BPD in order to support the diagnosis of BPD exclusion criteria.
Time Frame
Baseline (2 weeks pre-ERG ST)
Title
Patient Health Questionnaire (PHQ)
Description
A diagnostic tool that will be used as a screener for depression, anxiety, eating disorders and alcohol use.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Readiness for Change
Description
Participants will indicate their readiness to engage in treatment using the Readiness for Change questionnaire which was derived directly from the GAIN-Q3.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 1 of ERG ST
Title
Validating and Invalidating Response Scale (VIRS-kids)
Description
VIRS-kids is a measure of how much a caregiver's validation and invalidation impacts a youth's emotional regulation, behavior and care giver-youth relationship satisfaction.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 1 and 12 of ERG ST and 12 weeks after the end of ERG ST
Title
The M.I.N.I. International Neuropsychiatric Interview
Description
This is a brief structured interview for the major psychiatric disorders in the DSM. It assesses for: major depressive episode, suicidality, manic episode, bipolar disorders, panic disorder, agoraphobia, social phobia, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, substance use and dependence, psychotic disorders, anorexia nervosa, bulimia nervosa, generalized anxiety disorder. The M.I.N.I. will be used to ensure that exclusion criteria are not being met.
Time Frame
Baseline (2 weeks pre-ERG ST) and Week 12 of ERG ST
Title
Borderline Symptom List 23 (BSL-23)
Description
The BSL-23 will be used to screen for Borderline Personality Disorder (BPD) symptoms and self-harm behaviours.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Brief Treatment History Interview (B-THI)
Description
A selection of questions from the B-THI that contains face-valid questions will be used to assess for hospitalization and psychiatric emergency use, psychotropic medication and receipt of ancillary psychotherapy.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Family Assessment Device (FAD)
Description
FAD is a 53 item self-report measure designed to measure family function (31). The FAD is made up of seven scales which measure Problem Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behaviour Control and General Functioning. The reliability, measured using Cronbach's alpha, ranged from 0.72 (Roles and Behaviour Control) to 0.92 (General Functioning).
Time Frame
Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Texas Grief Inventory
Description
The Texas Grief Inventory, which has three subscales: grief (15 items), mastery (15 items) and empowerment (19 items), will be used to measure caregivers' sense of empowerment.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Title
Adult Behaviour Checklist (ABCL)
Description
The Adult Behaviour Checklist for ages 18-59 (ABCL) is a checklist used to obtain information on a range of mental health and substance use concerns. The family/friends will report on the youth's difficulties. Authors report internal consistency alphas ranging from 0.78 to 0.85 and test-retest reliability ranging from r = 0.73-0.92.
Time Frame
Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Help-seeking youth (ages 17-25 years) Literacy in English Early stage mental health concerns of mild to moderate severity Emotional dysregulation Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Zipursky, MD
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton - Youth Wellness Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P4W6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17908024
Citation
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.
Results Reference
background
PubMed Identifier
19246029
Citation
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.
Results Reference
background

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Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth

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