Problem BehaviorNCT02671487
Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza
A study testing Mind-Body Skills Groups in people with Problem Behavior and Aggression, run by The Center for Mind-Body Medicine at 1 site in Palestinian Territories.
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… Read more about this study
- Who is it for?
- Ages 14 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Problem Behavior, Aggression, Posttraumatic Stress Disorder
- What is being tested?
- Mind-Body Skills Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- Jan 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
The Center for Mind-Body Medicine
Gaza, Remal Area, Al Hasham Building
About this study
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.
Read the 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.
- Conditions
- Problem Behavior, Aggression, Posttraumatic Stress Disorder
- Being tested
- Mind-Body Skills Groups
- Keywords
- Problem Behavior, Aggression, Posttraumatic Stress Disorder, Adolescents
- Medical subject headings
- Problem Behavior, Aggression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Skills GroupsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Skills Groups | Experimental | Mind-body skills groups will be administered for 2 hours once a week for 10 weeks and then once a month for 10 months. Receives: Behavioral: Mind-Body Skills Groups |
| Wait List Control | No intervention | No intervention will be administered. Students will have the opportunity to receive the intervention at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 10 month follow-up after the program ends
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: Change from Baseline to 10 month follow-up after the program ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Mind-Body Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James S. Gordon, M.D., The Center for Mind-Body Medicine
- Investigators
- Jamil A Atti, MS, Study director, The Center for Mind-Body Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671487
- Sponsor's protocol ID
- GT-CMBM-002
- Status last verified
- Jul 2018
- First submitted
- 26 Jan 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-Body Skills Groups for Behavioral and Emotional Problems in War-Traumatized Male Adolescents in Gaza
- ClinicalTrials.gov ID
- NCT02671487
- Acronym / sponsor ID
- GT-CMBM-002
- Conditions
- Problem Behavior, Aggression, Posttraumatic Stress Disorder
- Keywords
- Problem Behavior, Aggression, Posttraumatic Stress Disorder, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- The Center for Mind-Body MedicineUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Skills Groups | Experimental | Behavioral: Mind-Body Skills GroupsMind-body skills groups will be administered for 2 hours once a week for 10 weeks and then once a month for 10 months. |
| Wait List Control | No intervention | –No intervention will be administered. Students will have the opportunity to receive the intervention at the end of the study. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body Skills GroupsMind-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. | Behavioural | Mind-Body Skills Groups |
Primary outcome
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.
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.
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.
6 secondary outcomes
The Aggression Questionnaire
Time frame: 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
The Aggression Questionnaire
Time frame: 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)
PTSD Checklist-5
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- The Center for Mind-Body Medicine WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamil A Atti, MS study director
The Center for Mind-Body Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Skills Groups in people with Problem Behavior and Aggression, run by The Center for Mind-Body Medicine at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (time frame: Change from Baseline to the end of the 10 week program (Post)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.