NCT02671487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

January 26, 2016

Last Update Submit

July 16, 2018

Conditions

Keywords

Problem BehaviorAggressionPosttraumatic Stress DisorderAdolescents

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • The Aggression Questionnaire

    Change from Baseline to the end of the 10 week program (Post)

  • The Aggression Questionnaire

    Change from the end of the 10 week program (Post) to 10 month-follow up

  • The Aggression Questionnaire

    Change from Baseline to 10 month follow-up after the program ends

  • PTSD Checklist-5

    Change from Baseline to the end of the 10 week program (Post)

  • PTSD Checklist-5

    Change from the end of the 10 week program (Post) to 10 month-follow up

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Mind-Body Skills Groups

Eligibility Criteria

Age14 Years - 17 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Mind-Body Medicine

Gaza, Remal Area, Al Hasham Building, Palestinian Territories

Location

Related Links

MeSH Terms

Conditions

Problem BehaviorAggressionStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild BehaviorAberrant Motor Behavior in DementiaSocial BehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Jamil A Atti, MS

    The Center for Mind-Body Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 2, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations