Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza

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: NCT02671487
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
James S. Gordon, M.D., The Center for Mind-Body Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Problem Behavior Aggression Posttraumatic Stress Disorder Behavioral: Mind-Body Skills Groups Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza
Actual Study Start Date : January 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Mind-Body Skills Groups
Mind-body skills groups will be administered for 2 hours once a week for 10 weeks and then once a month for 10 months.
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.

No Intervention: Wait List Control
No intervention will be administered. Students will have the opportunity to receive the intervention at the end of the study.



Primary Outcome Measures :
  1. Strengths and Difficulties Questionnaire [ Time Frame: Change from Baseline to the end of the 10 week program (Post) ]
    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.

  2. Strengths and Difficulties Questionnaire [ Time Frame: Change from the end of the 10 week program (Post) to 10 month-follow up ]
    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.

  3. Strengths and Difficulties Questionnaire [ Time Frame: Change from Baseline to 10 month follow-up after the program ends ]
    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.


Secondary Outcome Measures :
  1. The Aggression Questionnaire [ Time Frame: Change from Baseline to the end of the 10 week program (Post) ]
    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.

  2. The Aggression Questionnaire [ Time Frame: Change from the end of the 10 week program (Post) to 10 month-follow up ]
    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.

  3. The Aggression Questionnaire [ Time Frame: Change from Baseline to 10 month follow-up after the program ends ]
    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.

  4. PTSD Checklist-5 [ Time Frame: Change from Baseline to the end of the 10 week program (Post) ]
    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."

  5. PTSD Checklist-5 [ Time Frame: Change from the end of the 10 week program (Post) to 10 month-follow up ]
    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."

  6. PTSD Checklist-5 [ Time Frame: Change from Baseline to 10 month follow-up after the program ends ]
    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."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671487


Locations
Layout table for location information
Palestinian Territory, occupied
The Center for Mind-Body Medicine
Gaza City, Remal Area, Palestinian Territory, occupied, Al Hasham Building
Sponsors and Collaborators
The Center for Mind-Body Medicine
Investigators
Layout table for investigator information
Study Director: Jamil A Atti, MS The Center for Mind-Body Medicine
Additional Information:
Layout table for additonal information
Responsible Party: James S. Gordon, M.D., Director, The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier: NCT02671487    
Other Study ID Numbers: GT-CMBM-002
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by James S. Gordon, M.D., The Center for Mind-Body Medicine:
Problem Behavior
Aggression
Posttraumatic Stress Disorder
Adolescents
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Aggression
Problem Behavior
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms