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Self-Defense Training in Women With Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01380379
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : February 1, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Keller, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Anxiety
Stress Disorders, Post-Traumatic
Intervention Behavioral: Life skills and self-defense training
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Life Skills and Self-defense Training
Hide Arm/Group Description

Women will participate in a therapeutic group which covers education, skills, and empowerment activities.

Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing.

Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Pregnancy             1
Arm/Group Title Life Skills and Self-defense Training
Hide Arm/Group Description

Women will participate in a therapeutic group which covers education, skills, and empowerment activities.

Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing.

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
46.38  (9.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  44.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
  55.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
 100.0%
1.Primary Outcome
Title Change in Self-efficacy From Baseline to Post-treatment
Hide Description General self-efficacy (Schwartz and Jerusalem, 1993) is a measure of one's perceived self-competence. Scores are summed across 10 items, and range between 10-40, where higher scores reflect a stronger sense of personal competence.
Time Frame Change in GSE from baseline to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The data is the change in general self efficacy from baseline to post-class, with higher scores indicating a greater increase in self-efficacy
Arm/Group Title Life Skills and Self-defense Training
Hide Arm/Group Description:

Women will participate in a therapeutic group which covers education, skills, and empowerment activities.

Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline General Self efficacy 23.38  (5.8)
Week 8 (post-class) GSE 29.63  (3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Life Skills and Self-defense Training
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments [Not Specified]
Method t-test, 2 sided
Comments Single group comparison pre-post change score, compared to a value of 0 (no change)
2.Secondary Outcome
Title Change in Assertiveness Between Baseline and Post-intervention
Hide Description

Measured by the Rathus Assertiveness Schedule (Rathus, 1973). Rathus Assertiveness Scale is a 30-item scale assessing assertive behavior in a variety of situations. Each item is rated on a 6-point Likert scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). Total scores range from +90, which is equivalent of very assertive behavior to -90, which is equivalent to very unassertive behavior.

The positive change indicates an increase in assertive behavior.

Time Frame Change in assertiveness from baseline to post-class (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Life Skills and Self-defense Training
Hide Arm/Group Description:

Women will participate in a therapeutic group which covers education, skills, and empowerment activities.

Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Assertiveness Total -24.88  (34.6)
Week 8 (post-class) Assertiveness Total -15.88  (33.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Life Skills and Self-defense Training
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Life Skills and Self-defense Training
Hide Arm/Group Description

Women will participate in a therapeutic group which covers education, skills, and empowerment activities.

Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing.

All-Cause Mortality
Life Skills and Self-defense Training
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Life Skills and Self-defense Training
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Life Skills and Self-defense Training
Affected / at Risk (%) # Events
Total   1/8 (12.50%)    
Psychiatric disorders   
Dissociation during class *  1/8 (12.50%)  8
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jennifer Keller
Organization: Stanford University
Phone: 650-724-0070
EMail: jkeller@stanford.edu
Layout table for additonal information
Responsible Party: Jennifer Keller, Stanford University
ClinicalTrials.gov Identifier: NCT01380379    
Other Study ID Numbers: SU-04152011-7701
20776
First Submitted: May 18, 2011
First Posted: June 27, 2011
Results First Submitted: October 11, 2016
Results First Posted: February 1, 2017
Last Update Posted: February 1, 2017