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

Primary Purpose

Problem Behavior, Aggression, Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Palestinian Territory, occupied
Study Type
Interventional
Intervention
Mind-Body Skills Groups
Sponsored by
The Center for Mind-Body Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Problem Behavior focused on measuring Problem Behavior, Aggression, Posttraumatic Stress Disorder, Adolescents

Eligibility Criteria

14 Years - 17 Years (Child)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Center for Mind-Body Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mind-Body Skills Groups

Wait List Control

Arm Description

Mind-body skills groups will be administered for 2 hours once a week for 10 weeks and then once a month for 10 months.

No intervention will be administered. Students will have the opportunity to receive the intervention at the end of the study.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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."
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."
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."

Full Information

First Posted
January 26, 2016
Last Updated
July 16, 2018
Sponsor
The Center for Mind-Body Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02671487
Brief Title
Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza
Official Title
Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Center for Mind-Body Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Behavior, Aggression, Posttraumatic Stress Disorder
Keywords
Problem Behavior, Aggression, Posttraumatic Stress Disorder, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mind-Body Skills Groups
Arm Type
Experimental
Arm Description
Mind-body skills groups will be administered for 2 hours once a week for 10 weeks and then once a month for 10 months.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
No intervention will be administered. Students will have the opportunity to receive the intervention at the end of the study.
Intervention Type
Behavioral
Intervention Name(s)
Mind-Body Skills Groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
Strengths and Difficulties Questionnaire
Description
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.
Time Frame
Change from Baseline to the end of the 10 week program (Post)
Title
Strengths and Difficulties Questionnaire
Description
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.
Time Frame
Change from the end of the 10 week program (Post) to 10 month-follow up
Title
Strengths and Difficulties Questionnaire
Description
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.
Time Frame
Change from Baseline to 10 month follow-up after the program ends
Secondary Outcome Measure Information:
Title
The Aggression Questionnaire
Description
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.
Time Frame
Change from Baseline to the end of the 10 week program (Post)
Title
The Aggression Questionnaire
Description
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.
Time Frame
Change from the end of the 10 week program (Post) to 10 month-follow up
Title
The Aggression Questionnaire
Description
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.
Time Frame
Change from Baseline to 10 month follow-up after the program ends
Title
PTSD Checklist-5
Description
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."
Time Frame
Change from Baseline to the end of the 10 week program (Post)
Title
PTSD Checklist-5
Description
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."
Time Frame
Change from the end of the 10 week program (Post) to 10 month-follow up
Title
PTSD Checklist-5
Description
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."
Time Frame
Change from Baseline to 10 month follow-up after the program ends

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil A Atti, MS
Organizational Affiliation
The Center for Mind-Body Medicine
Official's Role
Study Director
Facility Information:
Facility Name
The Center for Mind-Body Medicine
City
Gaza City
State/Province
Remal Area
ZIP/Postal Code
Al Hasham Building
Country
Palestinian Territory, occupied

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.cmbm.org
Description
The Center for Mind-Body Medicine Website

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

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