Health BehaviorNCT02829086
Evaluation of the Refugee Family Strengthening (RFS) Program
A study testing Relationship Enhancement, Family Stress and Conflict Management and Financial Management in people with Health Behavior, run by US Committee for Refugees and Immigrants at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Relationship Enhancement, Family Stress and Conflict Management and Financial Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,365 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jul 2016to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Refugee or Immigrant
Who cannot join
- Individuals under the age of 16
- Individuals that are not identified as refugees or immigrants
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
USCRI Albany
Albany, New York, 12204
Vermont Refugee Resettlement Program
Colchester, Vermont, 05446
USCRI Detroit
Dearborn, Michigan, 48126
USCRI Des Moines
Des Moines, Iowa, 50314
International Institute of Erie
Erie, Pennsylvania, 16504
YMCA International Services
Houston, Texas, 77057
Jewish Vocational Services
Kansas City, Missouri, 64110
International Institute of Los Angeles
Los Angeles, California, 90033
Nationalities Services Center
Philadelphia, Pennsylvania, 19107
USCRI North Carolina
Raleigh, North Carolina, 27609
International Institute of St. Louis
St Louis, Missouri, 63118
About this study
Official title: Evaluation of the U.S. Committee for Refugees and Immigrants (USCRI): Refugee Family Strengthening (RFS) Program
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:
- Participants will identify utilizing healthy marriage and relationship skills.
- Participants will report an increase in satisfaction with conflict management with others after completion of the relationship workshop series.
- Participants will report an increase in quality and time spent with children.
- Participants will report an increase in economic stability.
Read the 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:
- 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?
- What are the differences in gains for subjects who participate in the two different interventions?
- 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.
- Conditions
- Health Behavior
- Being tested
- Relationship Enhancement, Family Stress and Conflict Management, Financial Management
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship EnhancementOther
Relationship Enhancement is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.
Family Stress and Conflict ManagementOther
Family Stress and Conflict Management is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.
Financial ManagementOther
Family Management is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | 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 Receives: Other: Relationship Enhancement; Other: Family Stress and Conflict Management |
| Group II | Experimental | Participants in Group II will receive the following interventions: Intro to Relationship Enhancement (8 hours), RE \& Financial Management (8 hours), and case management Receives: Other: Relationship Enhancement; Other: Financial Management |
| Group III | No intervention | Participants in Group III will receive the the standard care of all participants, case management ONLY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Relationship Skills
Questionnaire developed for intervention to measure change from before 8 hour intervention to after intervention
Measured: At program enrollment-during registration, immediately after completing 8 hour Relationship Enhancement intervention and at 6 month follow up.
Secondary outcomes (2)
Conflict Management Skills
Questionnaire developed for intervention to measure change from before 8 hour intervention to after intervention
Measured: 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
Measured: At program enrollment-during registration, immediately after completing 8 hour Financial Literacy intervention and at 6 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,365 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Committee for Refugees and Immigrants
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Salerno, DNP, Principal investigator, Possibilities for Change
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829086
- Sponsor's protocol ID
- 90FM0092-01-00
- Status last verified
- Apr 2020
- First submitted
- 29 Jun 2016
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the U.S. Committee for Refugees and Immigrants (USCRI): Refugee Family Strengthening (RFS) Program
- ClinicalTrials.gov ID
- NCT02829086
- Acronym / sponsor ID
- 90FM0092-01-00
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,365 participants (actual)
- Lead sponsor
- US Committee for Refugees and ImmigrantsUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participants will identify utilizing healthy marriage and relationship skills.
- Participants will report an increase in satisfaction with conflict management with others after completion of the relationship workshop series.
- Participants will report an increase in quality and time spent with children.
- 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:
- 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?
- What are the differences in gains for subjects who participate in the two different interventions?
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Relationship Enhancement, Other: Family Stress and Conflict ManagementParticipants in Group I will receive the following interventions: Intro to Relationship Enhancement (8 hours), Family Stress and Conflict Management (8 hours), and case management |
| Group II | Experimental | Other: Relationship Enhancement, Other: Financial ManagementParticipants in Group II will receive the following interventions: Intro to Relationship Enhancement (8 hours), RE \& Financial Management (8 hours), and case management |
| Group III | No intervention | –Participants in Group III will receive the the standard care of all participants, case management ONLY |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Refugee or Immigrant
Key exclusion criteria (2 listed)
- Individuals under the age of 16
- Individuals that are not identified as refugees or immigrants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relationship EnhancementRelationship Enhancement is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention. | Other | Group I, Group II |
| Family Stress and Conflict ManagementFamily Stress and Conflict Management is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention. | Other | Group I |
| Financial ManagementFamily Management is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention. | Other | Group II |
Primary outcome
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
2 secondary outcomes
Conflict Management Skills
Time frame: At program enrollment-during registration, immediately after completing 8 hour Conflict Resolution intervention and at 6 month follow up.
Economic Stability
Time frame: At program enrollment-during registration, immediately after completing 8 hour Financial Literacy intervention and at 6 month follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Salerno, DNP principal investigator
Possibilities for Change
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relationship Enhancement, Family Stress and Conflict Management and Financial Management in people with Health Behavior, run by US Committee for Refugees and Immigrants at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Relationship Skills (time frame: At program enrollment-during registration, immediately after completing 8 hour Relationship Enhancement intervention and at 6 month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.