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

July 16, 2018 updated by: James S. Gordon, M.D., The Center for Mind-Body Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to the end of the 10 week program (Post)
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.
Change from the end of the 10 week program (Post) to 10 month-follow up
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.
Change from Baseline to 10 month follow-up after the program ends

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to the end of the 10 week program (Post)
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.
Change from the end of the 10 week program (Post) to 10 month-follow up
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.
Change from Baseline to 10 month follow-up after the program ends
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."
Change from Baseline to the end of the 10 week program (Post)
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."
Change from the end of the 10 week program (Post) to 10 month-follow up
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."
Change from Baseline to 10 month follow-up after the program ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Mind-Body Medicine

Investigators

  • Study Director: Jamil A Atti, MS, The Center for Mind-Body Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (ESTIMATE)

February 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-CMBM-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aggression

Clinical Trials on Mind-Body Skills Groups

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe