- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03760627
Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is designed to examine the effects of the Mindfulness Resiliency Training Program (MRTP) conducted at Collateral Repair Project (CRP) on the resilience of refugees. The study group and the control group will be recruited from refugees currently residing in Amman, Jordan who are participating in the MRTP at CRP, an ongoing program independent of our study.
In order to assess the effect of the MRTP on participant resiliency, the three survey tools described above will be used:
- the Strength and Difficulties Questionnaire (SDQ) as a measure of the individual's degree of traumatization and
- the Child and Youth Resiliency Measure (CYRM-12) (for adolescents) or the Adult Resiliency Measure (ARM-12) (for adults) as a measure of resiliency
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amman, Jordan
- Collateral repair Project
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants who will be recruited in the study are adult and adolescent (13-19 years) refugees, Syrian and non-Syrians, who are currently residing in Amman, Jordan who will be participating in the MRTP at CRP.
Exclusion Criteria:
- Jordanian refugees residing in Amman, Jordan.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Refugees Mindfulness Resiliency Training
The Collateral Repair Project (CRP) will conduct a Mindfulness Resiliency Training Program (MRTP) for refugees residing in Amman, Jordan.
A small support group will demonstrate to participants techniques that they can use to self-manage their own stress and trauma.
|
The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.
|
|
Placebo Comparator: Control arm
The control group will receive the training after the study group at 2 months and the control group will then become the study group for the new session.
A new group of 20 participants will be recruited who will act as a control for that session.
The surveys from the control group will be compared with the study group at 0 and 2 months.
Each session will last for two months.
The control group will receive the training at the end of the two months.
This process will be repeated for a total of nine sessions over a total period of 12 months.
|
The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess Mindfulness Resiliency Adolescents
Time Frame: 2 months
|
In order to assess the effect of the Mindfulness Resiliency Training Program (MRTP) on participant resiliency, the Child and Youth Resiliency Measurement (CYRM-12) 12 question assessment tool for adolescents will be used to measure an increase in scores from baseline.
|
2 months
|
|
Assess Mindfulness Resiliency Adolescents
Time Frame: 6 months
|
In order to assess the effect of the MRTP on participant resiliency, the CYRM-12 for adolescents will be used to measure an increase in scores from baseline.
|
6 months
|
|
Assess Mindfulness Resiliency Adults
Time Frame: 2 months
|
In order to assess the effect of the MRTP on participant resiliency, the Adult Resiliency Measurement 12 question assessment tool (ARM-12) will be used to measure an improvement in score from pre-intervention baseline.
|
2 months
|
|
Assess Mindfulness Resiliency Adults
Time Frame: 6 months
|
In order to assess the effect of the MRTP on participant resiliency, the Adult Resiliency Measurement tool (ARM-12) will be used to measure an improvement in score from pre-intervention baseline.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saquib Lakhani, MD, Yale University
- Principal Investigator: Prachi Syngal, MD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000024279
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.