Evaluation of the Refugee Family Strengthening (RFS) Program

• ClinicalTrials.gov Identifier: NCT02829086
• Recruitment Status: Completed
• First Posted: July 12, 2016
• Last Update Posted: April 28, 2020
• Sponsor: US Committee for Refugees and Immigrants
• Information provided by (Responsible Party): US Committee for Refugees and Immigrants

Tracking Information

• First Submitted Date: June 29, 2016
• First Posted Date: July 12, 2016
• Last Update Posted Date: April 28, 2020
• Actual Study Start Date: July 1, 2016
• Actual Primary Completion Date: March 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2017)

Healthy Relationship Skills [ Time Frame: At program enrollment-during registration, immediately after completing 8 hour Relationship Enhancement intervention and at 6 month follow up. ]

Questionnaire developed for intervention to measure change from before 8 hour intervention to after intervention

• Original Primary Outcome Measures (submitted: July 7, 2016): Healthy Relationship Skills - Questionnaire developed for intervention to measure change from before 8 hour intervention to after intervention [ Time Frame: At program enrollment-during registration, immediately after completing 8 hour Relationship Enhancement intervention and at 6 month follow up. ]

Current Secondary Outcome Measures (submitted: October 25, 2017)

• Conflict Management Skills [ Time Frame: At program enrollment-during registration, immediately after completing 8 hour Conflict Resolution intervention and at 6 month follow up. ]
  Questionnaire developed for intervention to measure change from before 8 hour intervention to after intervention
• Economic Stability [ Time Frame: At program enrollment-during registration, immediately after completing 8 hour Financial Literacy intervention and at 6 month follow up. ]
  Questionnaire developed for intervention to measure change from before 8 hour intervention to after intervention

Original Secondary Outcome Measures (submitted: July 7, 2016)

• Conflict Management Skills - Questionnaire developed for intervention to measure change from before 8 hour intervention to after intervention [ Time Frame: At program enrollment-during registration, immediately after completing 8 hour Conflict Resolution intervention and at 6 month follow up. ]
• Economic Stability - Questionnaire developed for intervention to measure change from before 8 hour intervention to after intervention [ Time Frame: At program enrollment-during registration, immediately after completing 8 hour Financial Literacy intervention and at 6 month follow up. ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Refugee Family Strengthening (RFS) Program
• Official Title: Evaluation of the U.S. Committee for Refugees and Immigrants (USCRI): Refugee Family Strengthening (RFS) Program

Brief Summary

The US Committee for Refugees and Immigrants (USCRI) will be conducting an evaluation of a healthy marriage and relationship program developed by USCRI titled Refugee Family Strengthening (RFS) Program. This program is funded through an initiative of the Administration for Children and Families, Office of Family Assistance (OFA).

The study is intended to measure if the identified interventions improve the well-being of individuals and families within the refugee and immigrant population served by USCRI. Outcomes to be measured include behavioral outcomes and perceptual changes towards healthy relationships, family development, and positive home environment. The study will examine the following:

1. Participants will identify utilizing healthy marriage and relationship skills.
2. Participants will report an increase in satisfaction with conflict management with others after completion of the relationship workshop series.
3. Participants will report an increase in quality and time spent with children.
4. Participants will report an increase in economic stability.

Detailed Description

The US Committee for Refugees and Immigrants (USCRI) will be conducting an evaluation of a healthy marriage and relationship program developed by USCRI titled Refugee Family Strengthening (RFS) Program. This program is funded through an initiative of the Administration for Children and Families, Office of Family Assistance (OFA).

The Refugee Family Strengthening (RFS) Program builds on literature and existing research from the healthy marriage and relationship initiatives developed by ACF over the last 10 years, in particular the Supporting Healthy Marriage Program initiative that established a randomized clinical trial. In addition, marriage and relationship education/ enrichment literature and research has expanded dramatically over the past 35 years. The most glaring shortcoming of this database is the limited types of populations that are sampled and included in studies. USCRI's RFS program will provide important data about a diverse group of subjects that is currently unavailable.

The aim of the evaluation is to determine the effect of participating in two interventions on the population of refugee and immigrant couples, families, and individuals, served by USCRI. The program will target individuals ages 16 and older using a randomized control design. The program will be implemented with individuals, couples, and families. RFSP will recruit 9,350 individuals over the 5 year tenure of the project, 3115 of which will serve as control subjects, the remaining 6,235 subjects will be randomly assigned to intervention groups at each of the 11 selected sites that are participating in the project. Control subjects will not receive the intervention workshops, only case management.

The intervention is to be delivered as follows:

Group I: Intro to Relationship Enhancement (RE) (8 hours), Family Stress & Conflict Management (8 hours), and case management Group II: Intro to Relationship Enhancement (RE) (8 hours), & Financial Management (8 hours), and case management Group III: Case management ONLY

Data will be collected and analyzed across 3 collection points: Pre-test immediately before the start of the interventions, Post-test immediately upon completion of the interventions, and again at 6 months following the pre-test date.

Results will be analyzed to determine gains towards the following research questions:

When participating in the RFS program:

1. Do individuals who participate in the two RFS interventions demonstrate favorable impact in the four program outcomes as compared to those who participate in the control?
2. What are the differences in gains for subjects who participate in the two different interventions?
3. What are the long-term effects of participation in the RFS interventions on individuals?

The local evaluation is expected to reflect progress toward project outcomes and is anticipated to demonstrate significant results that will be highlighted and prepared for dissemination.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Health Behavior

Intervention

• Other: Relationship Enhancement
  Relationship Enhancement is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.
• Other: Family Stress and Conflict Management
  Family Stress and Conflict Management is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.
• Other: Financial Management
  Family Management is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.

Study Arms

• Experimental: Group I
  Participants in Group I will receive the following interventions: Intro to Relationship Enhancement (8 hours), Family Stress and Conflict Management (8 hours), and case management
  Interventions:

  • Other: Relationship Enhancement
  • Other: Family Stress and Conflict Management
• Experimental: Group II
  Participants in Group II will receive the following interventions: Intro to Relationship Enhancement (8 hours), RE & Financial Management (8 hours), and case management
  Interventions:

  • Other: Relationship Enhancement
  • Other: Financial Management
• No Intervention: Group III
  Participants in Group III will receive the the standard care of all participants, case management ONLY

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 28, 2019): 5365
• Original Estimated Enrollment (submitted: July 7, 2016): 9350
• Actual Study Completion Date: March 31, 2020
• Actual Primary Completion Date: March 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Refugee or Immigrant

Exclusion Criteria:

• Individuals under the age of 16
• Individuals that are not identified as refugees or immigrants

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02829086
• Other Study ID Numbers: 90FM0092-01-00
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: US Committee for Refugees and Immigrants
• Original Responsible Party: Same as current
• Current Study Sponsor: US Committee for Refugees and Immigrants
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jennifer Salerno, DNP; Possibilities for Change

• PRS Account: US Committee for Refugees and Immigrants
• Verification Date: April 2020