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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02671487
Other study ID # GT-CMBM-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date March 2017

Study information

Verified date July 2018
Source The Center for Mind-Body Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether war-traumatize male adolescents with behavioral and emotional problems who participate in mind-body skills groups will have improvement in behavioral and emotional problems, aggression, and posttraumatic stress disorder (PTSD) symptoms, compared to a wait list control group.


Description:

Mind-body skills incorporate meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement in a small group setting. These groups have been used in war-traumatize populations in Kosovo, Gaza and the United States. This study will be investigating the effect of the mind-body skills groups on boys with behavioral and emotional problem at a high school in Gaza to determine if there is improvement in behavioral and emotional problems, aggression, and posttraumatic stress disorder. The results will be compared to a control high school with boys who will not be attending mind-body skills groups and who have experienced similar levels of trauma and also have behavioral and emotional problems.

The mind-body skills groups will be held for 2 hours once a week for 10 weeks and then once a month for 10 months. Measures will be taken at baseline, after the 10 week mind-body skills group program and again at 10 month follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date March 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria:

- Criteria for eligibility for the study will include having a baseline self-reported score of 18 points or higher on the Strengths and Difficulties Questionnaire which indicates high to very high levels of emotional and behavioral problems

Exclusion Criteria:

Study Design


Intervention

Behavioral:
Mind-Body Skills Groups
Mind-Body Skills groups consist of small groups of about 8-10 participants who learn and practice meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement.

Locations

Country Name City State
Palestinian Territory, occupied The Center for Mind-Body Medicine Gaza City Remal Area

Sponsors (1)

Lead Sponsor Collaborator
The Center for Mind-Body Medicine

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type Measure Description Time frame Safety issue
Primary Strengths and Difficulties Questionnaire The 25 item Strengths and Difficulties Questionnaire (SDQ) measures behavioral and emotional function. These 25 items are divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The SDQ is scored on a 3 point Likert-type scale with the responses "not true, "somewhat true", and "certainly true". Total SDQ scores include all the subscales except the prosocial scale. Change from Baseline to the end of the 10 week program (Post)
Primary Strengths and Difficulties Questionnaire The 25 item Strengths and Difficulties Questionnaire (SDQ) measures behavioral and emotional function. These 25 items are divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The SDQ is scored on a 3 point Likert-type scale with the responses "not true, "somewhat true", and "certainly true". Total SDQ scores include all the subscales except the prosocial scale. Change from the end of the 10 week program (Post) to 10 month-follow up
Primary Strengths and Difficulties Questionnaire The 25 item Strengths and Difficulties Questionnaire (SDQ) measures behavioral and emotional function. These 25 items are divided into 5 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The SDQ is scored on a 3 point Likert-type scale with the responses "not true, "somewhat true", and "certainly true". Total SDQ scores include all the subscales except the prosocial scale. Change from Baseline to 10 month follow-up after the program ends
Secondary The Aggression Questionnaire Aggression will be measured using the Aggression Questionnaire (AQ) which is a revision of the Buss-Durkee Hostility Inventory that has been widely used to measure aggression. The AQ consists of 34 items scored on a 5 point Likert-type scale with responses ranging from "not at all like me" to "completely like me". The AQ has the following subscales: physical aggression,verbal aggression, anger, hostility, and indirect aggression. Change from Baseline to the end of the 10 week program (Post)
Secondary The Aggression Questionnaire Aggression will be measured using the Aggression Questionnaire (AQ) which is a revision of the Buss-Durkee Hostility Inventory that has been widely used to measure aggression. The AQ consists of 34 items scored on a 5 point Likert-type scale with responses ranging from "not at all like me" to "completely like me". The AQ has the following subscales: physical aggression,verbal aggression, anger, hostility, and indirect aggression. Change from the end of the 10 week program (Post) to 10 month-follow up
Secondary The Aggression Questionnaire Aggression will be measured using the Aggression Questionnaire (AQ) which is a revision of the Buss-Durkee Hostility Inventory that has been widely used to measure aggression. The AQ consists of 34 items scored on a 5 point Likert-type scale with responses ranging from "not at all like me" to "completely like me". The AQ has the following subscales: physical aggression,verbal aggression, anger, hostility, and indirect aggression. Change from Baseline to 10 month follow-up after the program ends
Secondary PTSD Checklist-5 Posttraumatic Stress Disorder (PTSD) Symptoms will be measured using the PTSD Checklist-5 (PCL-5). PCL-5 is a a self-report measure that assesses 20 symptoms of PTSD. The rating scale is 0-4 for each symptom with responses ranging from "Not at all," "A little bit," Moderately," "Quite a bit," to "Extremely." Change from Baseline to the end of the 10 week program (Post)
Secondary PTSD Checklist-5 Posttraumatic Stress Disorder (PTSD) Symptoms will be measured using the PTSD Checklist-5 (PCL-5). PCL-5 is a a self-report measure that assesses 20 symptoms of PTSD. The rating scale is 0-4 for each symptom with responses ranging from "Not at all," "A little bit," Moderately," "Quite a bit," to "Extremely." Change from the end of the 10 week program (Post) to 10 month-follow up
Secondary PTSD Checklist-5 Posttraumatic Stress Disorder (PTSD) Symptoms will be measured using the PTSD Checklist-5 (PCL-5). PCL-5 is a a self-report measure that assesses 20 symptoms of PTSD. The rating scale is 0-4 for each symptom with responses ranging from "Not at all," "A little bit," Moderately," "Quite a bit," to "Extremely." Change from Baseline to 10 month follow-up after the program ends
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