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Trial record 45 of 205 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth

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ClinicalTrials.gov Identifier: NCT02540746
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : October 21, 2016
Sponsor:
Collaborator:
Hamilton Academic Health Sciences Organization
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton

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).


Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: ERG Skills Training Behavioral: Motivational Enhancement Behavioral: Family Skills Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth: A Pilot Randomized Trial
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ERG Skills Training
ERG Skills Training for 12 weeks
Behavioral: ERG Skills Training
Group-based Dialectical Behavior Therapy Skills Training for 12 weeks
Experimental: ERG Skills Training + ME
ERG Skills Training for 12 weeks preceded by Motivational Enhancement for 4 weeks
Behavioral: ERG Skills Training
Group-based Dialectical Behavior Therapy Skills Training for 12 weeks
Behavioral: Motivational Enhancement
Three week Motivational Enhancement group
Experimental: ERG Skills Training + FAM
ERG Skills Training with concurrent 12-week Family Skills Training
Behavioral: ERG Skills Training
Group-based Dialectical Behavior Therapy Skills Training for 12 weeks
Behavioral: Family Skills Training
12-week group-based family skills training using Family Connections model
Other Name: Family Connections
Experimental: ERG Skills Training + ME + FAM
ERG Skills Training with concurrent 12-week Family Skills Training preceded by Motivational Enhancement for 4 weeks
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
Other Name: Family Connections



Primary Outcome Measures :
  1. Change from Baseline in Emotion Regulation throughout 12-week ERG group, at post ERG group and 16-week follow-up to group. [ 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 ]
    The Difficulties in Emotion Regulation Scales is a 36-item self-report measure of emotion dysregulation with adequate psychometric properties.


Secondary Outcome Measures :
  1. GAIN-Q3-MI-ONT [ Time Frame: Baseline (2 weeks pre-ERG ST) and post-treatment (week 12 of ERG-ST) ]
    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.

  2. Sheehan Disability Scale [ 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 ]
    Functioning will be measured using the Sheehan Disability Scale, a self-report measure of functioning in: home, work/school, and the social realm.

  3. Kessler Psychological Distress Scale (K-10) [ 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 ]
    Psychological distress will be measured using the K-10, a brief and well-validated instrument.

  4. Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL) [ 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 ]
    The DBT-WCCL which has adequate validity and reliability, will be used as a measure of coping skills.

  5. The Depression Anxiety and Stress Scales 21 (DASS-21) [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST ]
    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.

  6. Burden Assessment Scale [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST ]
    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.

  7. Modified M.I.N.I. Screener (MMS) [ Time Frame: Baseline (2 weeks pre-ERG ST) ]
    The MMS is designed to identify people who need a mental health assessment, covering mood disorders, anxiety and psychotic disorders.

  8. Lifetime Suicide Attempt Self Injury (L-SASI) [ Time Frame: Baseline (2 weeks pre-ERG ST) ]
    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.

  9. The International Personality Disorder Examination (IPDE) [ Time Frame: Baseline (2 weeks pre-ERG ST) ]
    This measure will be used to determine a probable or negative diagnosis of BPD in order to support the diagnosis of BPD exclusion criteria.

  10. Patient Health Questionnaire (PHQ) [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST ]
    A diagnostic tool that will be used as a screener for depression, anxiety, eating disorders and alcohol use.

  11. Readiness for Change [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 1 of ERG ST ]
    Participants will indicate their readiness to engage in treatment using the Readiness for Change questionnaire which was derived directly from the GAIN-Q3.

  12. Validating and Invalidating Response Scale (VIRS-kids) [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 1 and 12 of ERG ST and 12 weeks after the end of ERG ST ]
    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.

  13. The M.I.N.I. International Neuropsychiatric Interview [ Time Frame: Baseline (2 weeks pre-ERG ST) and Week 12 of ERG ST ]
    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.

  14. Borderline Symptom List 23 (BSL-23) [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST ]
    The BSL-23 will be used to screen for Borderline Personality Disorder (BPD) symptoms and self-harm behaviours.

  15. Brief Treatment History Interview (B-THI) [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST ]
    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.

  16. Family Assessment Device (FAD) [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST ]
    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).

  17. Texas Grief Inventory [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST ]
    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.

  18. Adult Behaviour Checklist (ABCL) [ Time Frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST ]
    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.



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Ages Eligible for Study:   17 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540746


Contacts
Contact: Juliana I Tobon, PhD 905-522-1155 ext 39167 jtobon@stjoes.ca
Contact: Robert B Zipursky, MD 905-522-1155 ext 36250 bzipursk@stjoes.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton - Youth Wellness Centre Recruiting
Hamilton, Ontario, Canada, L8P4W6
Contact: Juliana I Tobon, PhD    905-522-1155 ext 39167    jtobon@stjoes.ca   
Contact: Robert B Zipursky, MD    905-522-1155 ext 36250    bzipursk@stjoes.ca   
Principal Investigator: Robert B Zipursky, MD         
Principal Investigator: Juliana I Tobon, PhD         
Sub-Investigator: Natasja Menezes, MD         
Sub-Investigator: Peter Bieling, PhD         
Sub-Investigator: Lisa Jeffs, MEd         
Sub-Investigator: David Streiner, PhD         
Sub-Investigator: Lisa Burckell, PhD         
Sub-Investigator: Allison J Ouimet, PhD         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Hamilton Academic Health Sciences Organization
Investigators
Principal Investigator: Robert B Zipursky, MD St. Joseph's Healthcare Hamilton

Publications:
Responsible Party: St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02540746     History of Changes
Other Study ID Numbers: 15-312
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Joseph's Healthcare Hamilton:
Emotional Dysregulation
Early Intervention
Youth Mental Health
Staging
Motivational Enhancement
Family Connections
Family Skills Training

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders