NCT02001246

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

November 27, 2013

Last Update Submit

November 14, 2016

Conditions

Keywords

mindfulnesscognitive behavior therapyawarenessangeraggression

Outcome Measures

Primary Outcomes (2)

  • Change from baseline at Post-assessment in the measure of the Youth Outcomes Questionnaire 30-item (YOQ30)

    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.

    Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)

  • Change from baseline at Post-assessment in the measure of the Brief Aggression Questionnaire (BAQ)

    The BAQ is a 12-item self-report scale identifying four facets of aggression: Physical Aggression, Verbal Aggression, Anger, and Hostility.

    Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)

Secondary Outcomes (2)

  • Change from baseline at Post-assessment in the measure of Mindfulness

    Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)

  • Change from baseline at Post-assessment in the measure of Self-compassion

    Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)

Study Arms (2)

Real Deal program for Anger Management

ACTIVE COMPARATOR

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

Mind-body Bridging program

EXPERIMENTAL

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

Interventions

Real Deal is an eight week program with sessions one day per week. Each session is approximately 2 hr long.

Real Deal program for Anger Management

MBB is an eight week program with sessions one day per week. Each session is approximately 2 hr long.

Mind-body Bridging program

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pain Research Center, Anesthesiology, University of Utah

Salt Lake City, Utah, 84108, United States

Location

Salt Lake County Youth Services

Salt Lake City, Utah, 84115, United States

Location

MeSH Terms

Conditions

Aggression

Interventions

Anger Management Therapy

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yoshio Nakamura, PhD

    University of Utah

    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
Research Associate Professor

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

January 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations