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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Problem Behavior, Aggression, Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Mind-Body Skills Groups


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Skills Groups<br>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<br>* 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.<br>|
| No Intervention: Wait List Control<br>No intervention will be administered. Students will have the opportunity to receive the intervention at the end of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Problem Behavior, Aggression, Posttraumatic Stress Disorder, Adolescents