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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Pain Research Center, Anesthesiology, University of Utah
      • Salt Lake City, Utah, United States, 84115
        • Salt Lake County Youth Services

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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)
Time Frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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).
Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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