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USCRI READY4Life Program

Primary Purpose

Communication, Problem Solving, Social Relationships

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
READY4Life Programming - classroom instruction
Sponsored by
US Committee for Refugees and Immigrants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Communication

Eligibility Criteria

14 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • United States Committe on Refugees and Immigrants
  • Youth Coop Inc.Recruiting
  • College of Southern Idaho Refugee ProgramRecruiting
  • USCRI Des MoinesRecruiting
  • Internationa Institute of MinnesotaRecruiting
  • USCRI North CarolinaRecruiting
  • USCRI ClevelandRecruiting
  • Nationalities Service CenterRecruiting
  • USCRI VermontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

READY4Life Programming - classroom instruction

No Intervention: Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Healthy Communication Skills Score
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.
Conflict Resolution, Management, and Problem-Solving Skills Score
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.
Healthy Relationship and Marriage Skills Score
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.
Progress Toward Greater Economic Stability
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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2022
Last Updated
July 27, 2022
Sponsor
US Committee for Refugees and Immigrants
Collaborators
US Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT05476185
Brief Title
USCRI READY4Life Program
Official Title
U.S. Committee for Refugees and Immigrants' READY4Life Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
US Committee for Refugees and Immigrants
Collaborators
US Department of Health and Human Services

4. Oversight

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

5. Study Description

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.
Detailed Description
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. Relationships, Education, Advancement, and Development for Youth for Life (READY4Life) 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 socioemotional development and promoting successful transitions to young adulthood. USCRI's READY4Life program will serve refugee and immigrant youth ages 14 to 24, including but not limited to those individuals receiving, or who previously received TANF and/or individuals who are eligible for TANF assistance; non-custodial and custodial single parents; low-income, at-risk individuals; parenting youth; individuals with disabilities; and other eligible demographics, with a focus on underserved populations. The Relationship Education curriculum, that was successfully used with an adult refugee/immigrant population, has been adapted for youth into a 16-hour curriculum composed of 1-, 2- and 4-hour sessions. Sessions are spaced a week apart to accommodate both federal requirements and research that shows relationship skills are best learned when practiced over time. . READY4Life will include ten communication and conflict resolution skills, as well as content information about effects of trauma on emotional stability and relationships, characteristics and advantages of healthy marriage, setting and achieving financial priorities and goals. Adaptations of the four core skills are taught: Expression Skills, Showing Understanding Skills, Discussion Skills, and Problem-Solving Skills. In the remaining hours of the curriculum, six additional skills are taught: Coaching and Conflict Management Skills, Self-Change and Helping Others Change Skills, and Generalization Skills and Maintenance Skills. Though not a part of the 10 Relationship Enhancement skills, time will also be devoted to financial management and making progress towards greater economic stability. The four primary research questions deal with: 1) Communication skills; 2) Conflict resolution, conflict management, and problem-solving skills; 3) Healthy relationship and marriage skills; 4) Progress towards greater economic stability. We have selected these research questions because we believe, and the literature supports the position, that these factors are of major importance in helping youth make a successful transition from adolescence to adulthood. The intervention participants will receive the IDEALS curriculum for community participants ages 14 to 24. Total: 16 hours per intervention participant (3,600 total intervention participants). The control group will not receive the curriculum (1,200 total control participants). Note: once the control participants have completed the pre-test questionnaire, post-test questionnaire and six-month follow-up, they will be eligible to receive the intervention services, but they will not be counted as an intervention participant. Their participation in the evaluation will end once the six-month follow-up questionnaire is collected. Educational Evaluators, Inc. (EEI) is the local evaluator on this project working with USCRI's READY4Life Program. We also want grantee staff to understand the importance of evaluation and to be familiar with the evaluation protocols. By working closely together from the initial development of the proposal and picking up that collaboration as soon as the grant award was made, the evaluation staff and the grantee staff work together to understand all dimensions of the program. We believe this strengthens the overall evaluation, since EEI is not simply looking in as outsiders, but has provided training in all evaluation procedures to all grantee project staff including the Project Director, Program Coordinators, and Data Collection Specialists. This again, strengthens the evaluation. Random Assignment. Participants will be randomly assigned the intervention group or the control group in a 3:1 ratio. Thus, of the total number of participants per year, 25% will be assigned to the control group, and the remaining 75% will be assigned to the intervention group. The evaluation team will use a random number generator created by Qualtrics to assign subjects to the intervention or control as described above. Demographic data for the intervention group will be compared with the control group to determine whether there are group differences on any of the demographic variables. If differences are detected between an intervention group and control group, then that variable will be used as a co-variate when comparing groups relative to outcome variables. The unit of analysis will be the individual participant, refugee/immigrant youth, ages 14-24. Many participants will be youth enrolled in high school grades 9-12, although participants up to the age of 24 will be eligible for enrollment. The program will not be provided during the school day, as part of the school curriculum. Some schools, however, will allow us to use the school facilities to provide the program in an after-school setting. The schools providing after-school settings have high percentages of English Language Learners and immigrant and refugee student populations. Several are part of the Refugee School Impact Working Group, offer the Success Management Academy Program targeting recent arrivals to the US, or come from districts offering Newcomer Centers serving immigrant and refugee students. This project targets low-income and at-risk, refugee and immigrant youth, ages 14-24. The target population will not differ from those who will be broadly served by the grant. Participants will be young people who self-identify as refugees or immigrants. An instrument was developed after a comprehensive review of the intervention to be implemented. This instrument is aligned with the research questions and hypotheses developed. The Local Evaluation Questionnaire (LEQ) contains 5 demographic questions and 55 questions to answer the primary and secondary research questionsThe four primary research questions deal with: 1) Communication skills; 2) Conflict resolution, conflict management, and problem-solving skills; 3) Healthy relationship and marriage skills; 4) Progress towards greater economic stability. We have selected these research questions because we believe, and the literature supports the position, that these factors are of major importance in helping youth make a successful transition from adolescence to adulthood. Statistical Power. Statistical power for evaluation of this study's hypotheses was calculated using Optimal Design Software for Multilevel and Longitudinal Research Version 3.01. Power calculations were computed to estimate minimum detectable effect sizes based on group comparisons over time, with an alpha of .05 and power of .80. Adequate power to detect small to moderate effect sizes (δ = .35) will be present if the total variance in the outcomes explained by the difference between groups is small (intervention correlation ρ =.05). If the intervention correlation is moderate (ρ = 0.10), the minimum detectable effect size will be moderate (δ = 0.46). With a much smaller sample, Denny and Young (2006) found statistically significant results for changes in knowledge, attitudes, hopelessness, self-efficacy, and sexual intent, with effect sizes, measured by Eta square, ranging from .029-.170. Based on this previous work, we feel confident the study will be sufficiently powered to examine the effects of interest. Statistical Analyses. Frequency counts and percentages will be used to report the characteristics of the sample. Factor analysis will be used to confirm that the items comprising a given variable load together on a single factor. Cronbach's alpha will be used to examine internal consistency of the items comprising the four outcome variables. Descriptive statistics will be used, reporting means and standard deviations for the four outcome variables. Differences by group, relative to demographic variables, such as gender and race, will be examined using chi-square. Data will also be analyzed using analysis of covariance. The pretest score of the outcome measure under consideration will be used as the covariate. Data will again be analyzed using analysis of covariance, but not only using the pretest score as a covariate, but also treatment dose level, and nationality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communication, Problem Solving, Social Relationships, Economic Stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
4800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
READY4Life Programming - classroom instruction
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention: Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
READY4Life Programming - classroom instruction
Intervention Description
The intervention group receives 16 hours of classroom instruction.
Primary Outcome Measure Information:
Title
Healthy Communication Skills Score
Description
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.
Time Frame
Time Frame: Pretest to Follow-up (six months after completion of the intervention - about 7 months after the pretest)
Title
Conflict Resolution, Management, and Problem-Solving Skills Score
Description
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.
Time Frame
Time Frame: Pretest to Follow-up (six months after completion of the intervention - about 7 months after the pretest)
Title
Healthy Relationship and Marriage Skills Score
Description
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.
Time Frame
Time Frame: Pretest to Follow-up (six months after completion of the intervention - about 7 months after the pretest)
Title
Progress Toward Greater Economic Stability
Description
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.
Time Frame
Time Frame: Pretest to Follow-up (six months after completion of the intervention - about 7 months after the pretest)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel Montesa
Phone
703-310-1130
Email
emontesa@uscrimail.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Young, Ph.D.
Organizational Affiliation
Educational Evaluators, Inc; Center for Evidence-Based Programming
Official's Role
Principal Investigator
Facility Information:
Facility Name
United States Committe on Refugees and Immigrants
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
22202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Youth Coop Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Sante
Phone
305-442-6900
Ext
4808
Email
alicia.sante@ycoopmail.org
First Name & Middle Initial & Last Name & Degree
Michael Young, Ph.D.
Facility Name
College of Southern Idaho Refugee Program
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeze Rwasama
Phone
208-736-2166
Email
ZRwasams@refugeecenter.csi.edu
First Name & Middle Initial & Last Name & Degree
Michael Young, Ph.D.
Facility Name
USCRI Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terri True-Funk
Phone
515-528-7525
Email
ktruefunk@uscrimail.org
First Name & Middle Initial & Last Name & Degree
Michael Young, PhD.
Facility Name
Internationa Institute of Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Graupman
Phone
651-647-0191
Email
jgraupman@iimn.org
First Name & Middle Initial & Last Name & Degree
Michael Young, Ph.D.
Facility Name
USCRI North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omer Omer
Phone
919-334-0072
Ext
4034
Email
oomer@uscrimail.org
First Name & Middle Initial & Last Name & Degree
Michael Young, Ph.D
Facility Name
USCRI Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren Hamm
Phone
216-450-0550
Email
dhamm@uscrimail.org
First Name & Middle Initial & Last Name & Degree
Michael Young, PhD
Facility Name
Nationalities Service Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwen Soffer
Phone
215-893-8400
Email
gsoffer@nscphilia.org
First Name & Middle Initial & Last Name & Degree
Michael Young, Ph.D.
Facility Name
USCRI Vermont
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amila Merdzanovic
Phone
802-654-1716
Email
amerdzanovic@uscri.org
First Name & Middle Initial & Last Name & Degree
Michael Young, PhD

12. IPD Sharing Statement

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USCRI READY4Life Program

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