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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02001246
Other study ID # IRB_00067796
Secondary ID
Status Terminated
Phase N/A
First received November 27, 2013
Last updated November 14, 2016
Start date January 2014
Est. completion date November 2016

Study information

Verified date November 2016
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 35
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 17 Years
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
Mind-body Bridging (MBB) program
MBB is an eight week program with sessions one day per week. Each session is approximately 2 hr long.

Locations

Country Name City State
United States Pain Research Center, Anesthesiology, University of Utah Salt Lake City Utah
United States Salt Lake County Youth Services Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Primary 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) No
Secondary Change from baseline at Post-assessment in the measure of Mindfulness 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) No
Secondary Change from baseline at Post-assessment in the measure of Self-compassion 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) No
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