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USCRI READY4Life Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05476185
Recruitment Status : Recruiting
First Posted : July 27, 2022
Last Update Posted : August 1, 2022
Sponsor:
Collaborator:
US Department of Health and Human Services
Information provided by (Responsible Party):
Michael Young, US Committee for Refugees and Immigrants

Brief Summary:
The U.S. Committee for Refugees and Immigrants (USCRI) has developed the Relationships, Education, Advancement, and Development for Youth for Life (READY4Life) Program. This is a 16-hour program for immigrants/refugees, ages 14 to 24. The program is designed to help young immigrants and refugees prepare for a successful life in the United States. The program is taught by USCRI program staff and is being implemented at eight sites across the U.S.: Cleveland, Ohio; Colchester, Vermont; Des Moines, Iowa; Miami, Florida; Philadelphia, Pennsylvania; Raleigh, North Carolina; Saint Paul, Minnesota; and Twin Falls, Idaho. The project also includes a rigorous evaluation component, featuring a Randomized Control Trial (RCT) design.

Condition or disease Intervention/treatment Phase
Communication Problem Solving Social Relationships Economic Stability Behavioral: READY4Life Programming - classroom instruction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned, in a three to one ratio, to the intervention group, or the control group. All participants will complete a pretest questionnaire and have access to case management services. The intervention group will receive 16 hours of Relationship Enhancement Education, then all participants will complete a posttest questionnaire. Six months after the posttest, all participants will complete a follow-up questionnaire.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: U.S. Committee for Refugees and Immigrants' READY4Life Program
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : May 30, 2025
Estimated Study Completion Date : September 30, 2025

Arm Intervention/treatment
Experimental: READY4Life Programming - classroom instruction
The intervention is an 16-hour classroom-based relationship education program taught by project staff. This instruction will strengthen and promote healthy marriages among young refugees and immigrants through education and comprehensive case management that will support an overall goal of helping youth build healthy relationship skills while supporting positive socio-emotional development and promoting successful transitions to young adulthood.
Behavioral: READY4Life Programming - classroom instruction
The intervention group receives 16 hours of classroom instruction.

No Intervention: No Intervention: Control
The control group does not receive any part of the classroom instruction that the intervention group receives. Like the intervention group, however, the control group does have access to case management.



Primary Outcome Measures :
  1. Healthy Communication Skills Score [ Time Frame: Time Frame: Pretest to Follow-up (six months after completion of the intervention - about 7 months after the pretest) ]
    This outcome is the participants' score on a healthy marriage/relationship skills scale. This is a 10 item scale. It was used in an article recently published in Family Relations. The principal investigator for the present study (Young) was also the lead author for the study published in Family Relations. A sample item from the scale is "It is important to show appreciation for others." In the Family Relations study the items in the scale loaded on a single factor at .56 or above. The internal consistency (Chronbach's alpha) at pretest was .87. The percentage of the variance explained by the first component was 46. The results table will report the mean scores of the intervention and control groups at pretest, posttest and follow-up, as well as the results from the statistical analysis.

  2. Conflict Resolution, Management, and Problem-Solving Skills Score [ Time Frame: Time Frame: Pretest to Follow-up (six months after completion of the intervention - about 7 months after the pretest) ]
    This outcome is the participants' score on a conflict management/ resolution skills scale. This is a 6 item scale. It was used in an article recently published in Family Relations. The principal investigator for the present study (Young) was also the lead author for the study published in Family Relations. A sample item from the scale is "I follow through on promises and agreements." In the Family Relations study the items in the scale loaded on a single factor at .60 or above. The internal consistency (Chronbach's alpha) at pretest was .83. The percentage of the variance explained by the first component was 54.The results table will report the mean scores of the intervention and control groups at pretest, posttest and follow-up, as well as the results from the statistical analysis.

  3. Healthy Relationship and Marriage Skills Score [ Time Frame: Time Frame: Pretest to Follow-up (six months after completion of the intervention - about 7 months after the pretest) ]
    This outcome is the participants' score on a healthy relationship and marriage skills scale. This is a 6 item scale. A sample item from the scale is "In times of crisis we can turn to each other for support." The results table will report the mean scores of the intervention and control groups at pretest, posttest and follow-up, as well as the results from the statistical analysis.

  4. Progress Toward Greater Economic Stability [ Time Frame: Time Frame: Pretest to Follow-up (six months after completion of the intervention - about 7 months after the pretest) ]
    This outcome is the participants' score on an attitudes about personal finances scale. This is a 6 item scale. It was used in an article recently published in Family Relations. The principal investigator for the present study (Young) was also the lead author for the study published in Family Relations. A sample item from the scale is "I can reduce conflict about money through discussion and problem solving." In the Family Relations study the items in the scale loaded on a single factor at .63 or above. The internal consistency (Chronbach's alpha) at pretest was .72 and .94 at posttest.The results table will report the mean scores of the intervention and control groups at pretest, posttest and follow-up, as well as the results from the statistical analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least 14 years old and no more than 24 years old
  • Must self-identify as a refugee or immigrant

Exclusion Criteria:

  • Younger than 14 years old or older than 24 years old
  • Does not identify as a refugee or immigrant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05476185


Contacts
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Contact: Emmanuel Montesa 703-310-1130 emontesa@uscrimail.org

Locations
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United States, District of Columbia
United States Committe on Refugees and Immigrants Active, not recruiting
Washington, District of Columbia, United States, 22202
United States, Florida
Youth Coop Inc. Recruiting
Miami, Florida, United States, 33126
Contact: Alicia Sante    305-442-6900 ext 4808    alicia.sante@ycoopmail.org   
Principal Investigator: Michael Young, Ph.D.         
United States, Idaho
College of Southern Idaho Refugee Program Recruiting
Twin Falls, Idaho, United States, 83301
Contact: Zeze Rwasama    208-736-2166    ZRwasams@refugeecenter.csi.edu   
Principal Investigator: Michael Young, Ph.D.         
United States, Iowa
USCRI Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Terri True-Funk    515-528-7525    ktruefunk@uscrimail.org   
Principal Investigator: Michael Young, PhD.         
United States, Minnesota
Internationa Institute of Minnesota Recruiting
Saint Paul, Minnesota, United States, 55108
Contact: Jane Graupman    651-647-0191    jgraupman@iimn.org   
Principal Investigator: Michael Young, Ph.D.         
United States, North Carolina
USCRI North Carolina Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Omer Omer    919-334-0072 ext 4034    oomer@uscrimail.org   
Principal Investigator: Michael Young, Ph.D         
United States, Ohio
USCRI Cleveland Recruiting
Cleveland, Ohio, United States, 44109
Contact: Darren Hamm    216-450-0550    dhamm@uscrimail.org   
Principal Investigator: Michael Young, PhD         
United States, Pennsylvania
Nationalities Service Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Gwen Soffer    215-893-8400    gsoffer@nscphilia.org   
Principal Investigator: Michael Young, Ph.D.         
United States, Vermont
USCRI Vermont Recruiting
Colchester, Vermont, United States, 05446
Contact: Amila Merdzanovic    802-654-1716    amerdzanovic@uscri.org   
Principal Investigator: Michael Young, PhD         
Sponsors and Collaborators
US Committee for Refugees and Immigrants
US Department of Health and Human Services
Investigators
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Principal Investigator: Michael Young, Ph.D. Educational Evaluators, Inc; Center for Evidence-Based Programming
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Responsible Party: Michael Young, Principal Investigator, US Committee for Refugees and Immigrants
ClinicalTrials.gov Identifier: NCT05476185    
Other Study ID Numbers: 001
First Posted: July 27, 2022    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022

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