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Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan

Primary Purpose

Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Mental Health Wellness 1, War-Related Trauma

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Refugees Mindfulness Resiliency Training
Mindfulness Resiliency Training
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Collateral repair Project

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Refugees Mindfulness Resiliency Training

Control arm

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Assess Mindfulness Resiliency Adolescents
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.
Assess Mindfulness Resiliency Adolescents
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.
Assess Mindfulness Resiliency Adults
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.
Assess Mindfulness Resiliency Adults
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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2018
Last Updated
October 19, 2021
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03760627
Brief Title
Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan
Official Title
Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To estimate the efficacy of a structured, scalable and replicable psychosocial intervention targeting refugees living in Jordan, Amman who have been forced to flee their homes due to regional conflicts.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Mental Health Wellness 1, War-Related Trauma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a stepped wedge cluster randomized trial design. The design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. The controls from the previous session who were available for the parallel portion of the study, will later become the treatment group while another control group is recruited for them, which in turn will become an intervention group and so forth.
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refugees Mindfulness Resiliency Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Refugees Mindfulness Resiliency Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Resiliency Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess Mindfulness Resiliency Adolescents
Description
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.
Time Frame
2 months
Title
Assess Mindfulness Resiliency Adolescents
Description
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.
Time Frame
6 months
Title
Assess Mindfulness Resiliency Adults
Description
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.
Time Frame
2 months
Title
Assess Mindfulness Resiliency Adults
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saquib Lakhani, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prachi Syngal, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Collateral repair Project
City
Amman
Country
Jordan

12. IPD Sharing Statement

Learn more about this trial

Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan

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