- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001246
Two Anger Management Programs for Teens.
November 14, 2016 updated by: Yoshio Nakamura, University of Utah
An Exploratory Study of Two Intervention Programs for Anger Management for Teens.
The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body bridging (MBB) for anger management compared with the Real Deal anger management program, in helping adolescents control or reduce their anger.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
In this pilot randomized-controlled study, we evaluate the effects of MBB as compared with an established anger management program (Real Deal), in helping youth prone to anger develop tools to effectively reduce and control their anger, and potentially reduce other negative emotions and feelings that might be associated with their anger.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84108
- Pain Research Center, Anesthesiology, University of Utah
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Salt Lake City, Utah, United States, 84115
- Salt Lake County Youth Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English-speaking
- self-, or allo-referred (parents, peers, court-ordered, school, etc.), based on their propensity for displaying various disruptive, externalizing behaviors, including, anger, hostility, oppositional behavior, and temper outbursts, and as such identified by Youth Services (YS) as a suitable candidate to attend a YS anger management program.
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Real Deal program for Anger Management
The Real Deal Anger Management Program is a structured, video-based intervention, which is an easy-to-implement, "plug and play" program that engages students in: (a) cognitive exercises for learning to recognize and correct thinking errors that lead to anger, (b) active practice of social-behavioral skills through role-playing, and (c) participation in progressive muscle relaxation exercises.
The program features three training videos that focus on specific skills for controlling conflict.
|
Real Deal is an eight week program with sessions one day per week.
Each session is approximately 2 hr long.
|
|
Experimental: Mind-body Bridging program
The Mind-Body Bridging program for anger management, includes experiential awareness activities, in which individuals learn to become aware of their thoughts, feelings, emotions, and bodily sensations, to help them identify and deal with ruminative and negative thoughts that might be associated with their anger.
MBB helps participants use their senses to listen to sounds, and experience visual or tactile input, to calm their minds and relax their bodies.
Written 'mapping' exercises enable them to recognize and defuse requirements, which are expectations of how they or the world should be.
For the MBB anger management program, participants will be provided with a variety of mapping exercises to identify the source of their anger, and how they can effectively control it.
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MBB is an eight week program with sessions one day per week.
Each session is approximately 2 hr long.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline at Post-assessment in the measure of the Youth Outcomes Questionnaire 30-item (YOQ30)
Time Frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
|
The Youth Outcome Questionnaire Self-Report 30 (YOQ-30) is a relatively brief (30-item) psychotherapy outcome measure, which considers general symptoms relevant to many youth mental health disorders and social issues.
YOQ-30 is appropriate for tracking youth outcomes over time.
It can be completed by adolescents between the ages of 12 and 18 and takes about five minutes to complete.
It comprises six subscales (Somatic, Social Isolation, Aggression, Conduct Problems, Hyperactivity/Distractibility, and Depression/ Anxiety).
A total score can be computed with 0 indicating no symptomatology and 120 indicating severe symptomatology.
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Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
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Change from baseline at Post-assessment in the measure of the Brief Aggression Questionnaire (BAQ)
Time Frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
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The BAQ is a 12-item self-report scale identifying four facets of aggression: Physical Aggression, Verbal Aggression, Anger, and Hostility.
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Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline at Post-assessment in the measure of Mindfulness
Time Frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
|
Five-facet Mindfulness Questionnaire (FFMQ) The FFMQ Short Form (FFMQ-SF) is a 15-item scale assessing five distinct, interpretable facets of mindfulness, including (1) observing, (2) describing, (3) acting with awareness, (4) non-judgement of inner experience, and (5) non-reactivity to inner experience.
|
Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
|
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Change from baseline at Post-assessment in the measure of Self-compassion
Time Frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
|
Self-Compassion Scale (SCS) The SCS short form (SCS-SF) is a 12-item scale used to measure self-compassion, an emotionally positive attitude that can protect against the negative consequences of self-judgment, isolation, and rumination (such as in depression).
Self-compassion has three main aspects: (1) self-kindness (being kind and understanding toward oneself in instances of pain or failure, rather than being harshly self-critical); (2) common humanity (perceiving one's experiences as part of the larger human experience, rather than seeing them as separating and isolating); and (3) mindfulness (holding painful thoughts and feelings in balanced awareness, rather than over-identifying with them).
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Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoshio Nakamura, PhD, University of Utah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
November 27, 2013
First Submitted That Met QC Criteria
November 27, 2013
First Posted (Estimate)
December 4, 2013
Study Record Updates
Last Update Posted (Estimate)
November 15, 2016
Last Update Submitted That Met QC Criteria
November 14, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00067796
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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