Trial record 13 of 139 for:    Open Studies | "Aggression"

Two Anger Management Programs for Teens.

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Yoshio Nakamura, University of Utah
ClinicalTrials.gov Identifier:
NCT02001246
First received: November 27, 2013
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Anger
Hostility
Aggression
Behavioral: Real Deal program for Anger Management
Behavioral: Mind-body Bridging (MBB) program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Study of Two Intervention Programs for Anger Management for Teens.

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    The BAQ is a 12-item self-report scale identifying four facets of aggression: Physical Aggression, Verbal Aggression, Anger, and Hostility.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Real Deal program for Anger Management
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.
Behavioral: Mind-body Bridging (MBB) program
MBB is an eight week program with sessions one day per week. Each session is approximately 2 hr long.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001246

Contacts
Contact: David L Lipschitz, PhD 801 585-7754 david.lipschitz@utah.edu

Locations
United States, Utah
Pain Research Center, Anesthesiology, University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: David L Lipschitz, PhD    801-585-7754    david.lipschitz@utah.edu   
Principal Investigator: Yoshio Nakamura, PhD         
Sub-Investigator: David L Lipschitz, PhD         
Salt Lake County Youth Services Recruiting
Salt Lake City, Utah, United States, 84115
Contact: Michael Johnson    385-468-4528    MKJohnson@slco.org   
Contact: Roger D Gisseman, PhD    385-468-4531    RGisseman@slco.org   
Sub-Investigator: Michael Johnson         
Sub-Investigator: Roger D Gisseman, PhD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Yoshio Nakamura, PhD University of Utah
  More Information

No publications provided

Responsible Party: Yoshio Nakamura, Research Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02001246     History of Changes
Other Study ID Numbers: IRB_00067796
Study First Received: November 27, 2013
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
mindfulness
cognitive behavior therapy
awareness
anger
aggression

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 21, 2014