Clinical trial NCT04227405: TOGETHER: A Couple's Model to Enhance Relationships and Economic Stability
Official title: TOGETHER: A Couple's Model to Enhance Relationships and Economic Stability
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: No Condition
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: Family Services, Inc.
name: The SkillSource Group, Inc.
name: AVAR Consulting, Inc.
First posted: 2020-01-13
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The current study sought to evaluate an intervention to promote healthy couple relationships and economic stability and mobility for low-income couples living in Northern Virginia (VA) and Montgomery and Prince George's Counties (MD). The approach proposed integrated two components:(1) a 20-hour evidence-informed couple group workshop called TOGETHER that integrates relationship and financial education, followed by an optional three-hour booster session three months after TOGETHER workshop and (2) case management (assessment of participant needs, development of Individual and Couple Development Plan(ICDP), referrals for social and mental health services, and referrals and coordination with job and career enhancement services, linking and coordination of all services as needed). The 20-hour workshop was offered in 8 sessions facilitated by couple and financial experts. The effectiveness of the program was evaluated through a randomized control trial in which couples were randomly assigned to a control group (n=147) or an intervention group (n=145). The control group received no intervention but a three-hour financial workshop after the last assessment was completed whereas the intervention couples participated in the 20-hour interventions and received case management. An independent local evaluator(AVAR, Consulting) participated in the design, implementation, and most of the data analysis. Participants had to be at least 18 years-old, living together for at least a year, and had no severe domestic violence issues, or untreated substance abuse or severe psychiatric disorders. If both partners were retired, couples were excluded from participation. Couples participated in an intake and enrollment meeting and were randomly assigned by a computer generated system to either the intervention or control group. Couples in both groups completed three sets of self-report measures: (1)Pre-test in first workshop session or at intake for control couples, (2)post-test in the last workshop session, or 8 weeks after the pre-test for control couples, and (3)follow-up six months after the post-test. After the six-month follow-up assessment, participation in the program was concluded. The study was largely funded by a Healthy Marriage and Responsible Fatherhood grant awarded by the Administration of Children and Families.

Detailed description: The current project sought to promote healthy couple relationships and economic stability and mobility for low-income couples living in Northern Virginia (VA) and Montgomery and Prince George's Counties (MD) This project was funded by the Administration for Children and Families (ACF) under the Healthy Marriage and Responsible Fatherhood (HMRF) program from the beginning of the study until May 10, 2018. As of May 10, 2018 ACF continued to fund the intervention component but data collection and analysis for couples that had been randomized by then and continued to receive services and to complete assessments were funded by Virginia Polytechnic Institute and State University. The evaluation plan that included a randomized control trial (RCT) and was approved of by ACF for years 2016, 2017, and 2018 until the local evaluation was discontinued by ACF included the enrollment of 720 couples, out of which 360 couples would be randomly assigned to the intervention group and 360 couples to a control group. However, due to the unexpected termination of funding for the local evaluation, the program was evaluated with 292 couples (145 intervention group couples and 147 control group couples).

This project was developed and conducted by Project Director, Mariana Falconier, Ph.D. at Virginia Tech and Associate Director until December, 2018 and since then at the University of Maryland (UMD), and Jinhee Kim, Ph.D. at UMD. UMD was a subawardee of Virginia Tech. Virginia Tech subcontracted with SkillSource Group, Inc. for delivery of employment services and University of Maryland contracted with Family Services, Inc. for delivery of workshop services. ACF required the grantee to have an independent local evaluator and for that purpose Virginia Tech contracted with AVAR Consulting, involved in the implementation and outcome evaluations until August 31, 2018. Additional analyses were conducted by D. Mark Lachowicz from UMD.

Our approach integrated two components (1) a 20-hour evidence-informed couple group program called TOGETHER workshop that integrates relationship education and financial literacy skills and (2) case management (assessment of participant needs, development of Individual and Couple Development Plan, referrals for community services, and referrals and coordination with job and career enhancement services).

Short-term outcomes of this project's core intervention were expected immediately after completion of the last session of the TOGETHERR workshop whereas medium-term outcomes were anticipated six months after that last session. Expected measurable outcomes among program participants for objective 1 (improved personal well-being) included increased frequency of positive stress management, reduced psychological distress, decreased financial stress. Expected measurable outcomes for objective 2 (improved couple's relationship skills) included increased frequency of positive communication behaviors, increased frequency of positive conflict management behaviors, increased frequency of positive dyadic stress management, increased frequency of conjoint problem solving behaviors, increased satisfaction with couple's relationship, and increased comfort with financial styles and roles. Expected measurable outcomes for objective 3 (improved parenting and co-parenting) included increased frequency of positive parenting behaviors, increased closeness to children, and increased satisfaction with co-parenting. Expected measurable outcomes for objective 4 (improved financial literacy and capability) include increased financial literacy skills, increased financial self-efficacy, decreased use of alternative financial services, and increased financial management behaviors. Finally, expected measurable outcomes for objective 5 (improved employability, job placement, and retention) include decreased perceived barriers to employability, increased intentions and motivations for work, increased confidence in job skills, and increased employability, employment status, and retention. These outcomes were expected by comparing the intervention and control group outcomes in the RCT.

Outcomes were evaluated through self-report measures provided ACF and additional standardized measures selected by the Project Director and Associated Project Director. Measures were completed at baseline, 8 weeks after, and six-month follow up. Couples received gift cards for survey completion.

TARGET POPULATION Low income couples in Northern Virginia (VA) and Prince George's County and Montgomery County, Maryland (MD) but all couples were if they met the eligibility criteria: Living together at least a year, 18 years or older, and English-speaking. Exclusion criteria included both partners being retired, physical domestic violence or feeling unsafe with partner in the last six months, untreated severe psychiatric disorder or/and severe untreated substance abuse disorder. Couples could participate as long as both partners consent to be part of the program.

RECRUITMENT Recruitment activities began on June 1, 2016 and included advertising through social media, distributing flyers, brochures, and posters and/or giving presentation in schools, churches and various community agencies. The program was also advertised through its own website.

DATABASES The funding agency ACF requires all HMRF grantees to enter information into a secure system called the Information, Family Outcomes, Reporting, and Management system (nFORM) regarding program operations, services,a nd participants' contract information and demographics. ACF required grantees to collect their outcome measures through nFORM and the researches added standardized self-report instrument to be collected through Qualtrics. Both nFORM and Qualtrics measures were used for the RCT. A database called Participant Tracking System (PTS) was developed for automated randomization and entering needs assessments and ICDPs.

PROCEDURES Individuals interested in participating in the program could contact us in person or by phone. Program staff collected contact information, described the program and the potential compensation, asked screening questions to each partner if both partners were available. Otherwise, the program staff collected information from the only partner that was present. Eligible participants that provided consent were scheduled for an Intake and Enrollment (IE) meeting with the case managers.

The first part of the IE meeting lasted 60 minutes. During the meeting, the case manager (a) described the program and obtained voluntary, informed written consent for program participation from both partners; (b) conducted a 10-minute formal assessment of domestic violence with each partner individually (couples at risk were referred to outside agency); (c) enrolled participants in nFORM; (d) assigned couples to intervention or control group through an automated system of randomization; (f) provided orientation about program procedures; and (g) directed couples to complete the nFORM applicant characteristics survey and a Qualtrics demographic information survey in a tablet The second part of the IE meeting was different for intervention and control couples. For intervention couples (90 minutes), the case manager described the services, conducted a Needs Assessment (areas: Health care, employment, housing, childcare, education, legal needs, finances, transportation, food, relationships, mental health, alcohol abuse, and substance abuse), scheduled the individual and couple development plan (ICDP) meeting and case management progress and exit meetings, and enrolled couples in one of the eight-week TOGETHER workshops and a three-hour booster session (three months the TOGETHER workshop. During part II (90 minutes) for control couples completed pre-test surveys including the Pre-Program Survey (nFORM) and Pre-test Assessment (Qualtrics).

Eight weeks after the IE meeting, control couples would meet with the case manager in a program location and complete the Post Program Survey in nFORM and the Post-test Assessment in Qualtrics (90 minutes) and received gift cards. Questionnaires mailed for those unable to attend. Six months later couples were invited to complete the follow-up survey in Qualtrics (90 minutes) before the beginning of the Financial Literacy Workshop (FLW). They received gift cards. If unable to attend, paper surveys were mailed. FLW was a three-hour financial management class to improve financial management knowledge and skills based on Money Smart curriculum.

INTERVENTION COUPLES

1. TOGETHER WORKSHOP TOGETHER workshop is a 20-hour psycho-educational program that integrates relationship and financial education. TOGETHER was developed by Dr. Mariana Falconier (PI) and the late Dr. Hayhoe as part of the emerging interdisciplinary field that integrates relationship education with financial education (Falconier, 2015). TOGETHER adapted the Couples' Coping Enhancement Training (CCET; Bodenmann \& Shantinah, 2004), whose effectiveness in improving stress management, communication, and relationship satisfaction has been supported in various studies (e.g., Bodenmann \& Shantinath, 2004), to financial stress. TOGETHER aims at reducing financial stress and improving relationship functioning by providing couples with knowledge and skills on individual and couple's stress management, communication, conflict resolution, problem-solving, and financial management. The TOGETHER workshop has 9 modules and is designed to be delivered in groups of four to eight couples: 8 weekly sessions of 2.5 hours each. Each session is co-led by two facilitators: a financial counselor and a couple therapist. Each session includes a warm-up activity, brief review of past session content and homework, presentation and practice of new content, summary of all contents covered in the session, and assignment of new homework. The TOGETHER curriculum has been pilot tested and results have been published in 2015 in the Journal of Marital and Family Therapy.

   Program Modules Introduction to program Module 1: Understanding Stress and Money Stress Module 2: Managing\* Stress and Money Stress by Yourself Module 3: Communicating Stress and Money Stress to Your Partner Module 4: Managing Stress and Money Stress with Your Partner Module 5: Communicating Effectively and Learning to Talk about Money Module 6: Clarifying Financial Roles and Expectations Module 7: Improving Money Management Skills Module 8: Credit and Risk Management Module 9: Improving Financial Problem-Solving Skills Thirty workshops were offered between July 1, 2016 and May 10, 2018. Out of the 145 couples assigned to the intervention group, 106 couples started the workshop. The rest of the couples could not attend any of the available workshops due to schedule conflicts. At the end of each session participants completed a 2 minute-session evaluation (last session survey also includes questions about the overall workshop) and a 2-minute homework evaluation.. At the first TOGETHER session, couples completed the Pre Program Survey (nFORM) and the Pre-test Assessment (Qualtrics) (total = 90 minutes) on a tablet before the session began. Couples absent in the first session were mailed paper surveys. After the last (eighth) TOGETHER session, couples completed on site the Post Program Survey (nFORM) and the Post-test Assessment (Qualtrics) (90 minutes) on tables or were mailed paper surveys if they failed to attend.
2. CASE MANAGEMENT One week after the first workshop session, intervention couples partook in an Individual and Couple Development Plan (ICDP) meeting with the assigned case. Based on the information collected in the Needs Assessment during the IE meeting, the case manager created an ICDP with the couple that included goals, action steps, potential barriers, and referrals to community services (i.e., housing, TANF, health care, mental health services, etc.). If the ICDP included a goal related employment/career a first meeting was scheduled for that partner with an employment case manager to receive services at either the SkillSource Group, Inc. or a federally funded employment agency in Maryland. The present study provided funding for (a) employment services for those participants that did not meet eligibility criteria to receive services funded through the Workforce Innovation and Opportunity Act (WIOA) or other state and local funding in those agencies.

   After the ICDP meeting, intervention couples met with the case manager for their five progress monthly meetings in order to check participants' progress towards goals, barriers, safety, program issues, and modifications to ICDP. There was an exit meeting with the case manager 6 months after the last TOGETHER workshop session during which couples completed the six-month follow-up survey. If unable to attend, paper surveys were mailed.
3. INCENTIVES FOR WORKSHOP ATTENDANCE At the third progress meeting, case managers provided the attendance incentives for the TOGETHER workshop.
4. BOOSTER SESSION Intervention couples were invited to an optional 3- hour booster session (abbreviated version of workshop content) three months after completing the last session of TOGETHER workshop.
5. FIDELITY Facilitators received a 25-hour training in the program, a biweekly one-hour group supervision with the curriculum developers, were observed by the curriculum developers and the local evaluators staff. Facilitators also completed jointly a checklist to report on the extent to which they completed the scheduled activities, met all session objectives, used all materials as outlined in the manual, and spent the time as planned.

A checklist was developed to assess the extent to which case managers were implementing the case management protocol.

Eligibility criteria: Inclusion Criteria

* Lliving together for at least a year
* Being at least 18 years
* English speaking.

Exclusion criteria:

* Current physical domestic violence and/ or feeling unsafe to participate with your partner in a psycho-educational group in the last twelve months
* Current diagnosis of a severe psychiatric disorder that required hospitalization in the last 12 months
* Cognitive impairment that prevent comprehension of materials and participation in a psycho-educational group
* Severe untreated substance abuse disorder
* Both partners fully retired.

Primary outcomes:
measure: Information, Family Outcomes, Reporting, and Management (nFORM)- Baseline/Pretest (Time1)
timeFrame: Pre-test/Baseline (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Information, Family Outcomes, Reporting, and Management (nFORM)- Post-test at 8 Weeks After Pre-test (Time2)
timeFrame: Post-test (8 weeks after pre-test/Time1)
measure: Information, Family Outcomes, Reporting, and Management (nFORM)- Six-month Follow-up (Time3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Brief Coping Orientation to Problems Experienced (COPE) Inventory- Baseline/Pre-test (Time1)
timeFrame: Baseline/Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Brief Coping Orientation to Problems Experienced (COPE) Inventory - Post- Test (Time2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Brief Coping Orientation to Problems Experienced (COPE) Inventory - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Brief Coping Orientation to Problems Experienced (COPE) Inventory in Relation to Financial Problems - Baseline/Pre-test (Time1)
timeFrame: Baseline/Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Brief Coping Orientation to Problems Experienced (COPE) Inventory in Relation to Financial Problems - Post- Test (Time2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Brief Coping Orientation to Problems Experienced (COPE) Inventory in Relation to Financial Problems - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Family Economic Strain Scale - Baseline/Pre-test (Time 1)
timeFrame: Baseline/Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Family Economic Strain Scale - Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Family Economic Strain Scale - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Difficulties in Emotion Regulation - Baseline/Pre-test (Time 1)
timeFrame: Baseline/Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Difficulties in Emotion Regulation - Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Difficulties in Emotion Regulation - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Conflict Tactics Scales-R - Baseline/Pre-test (Time 1)
timeFrame: Baseline/Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Conflict Tactics Scales-R Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Conflict Tactics Scales-R - Six Month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Depression, Anxiety, and Stress Scale - Stress Subscale Baseline/Pre-test (Time 1)
timeFrame: Baseline/Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Depression, Anxiety, and Stress Scale - Stress Subscale Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Depression, Anxiety, and Stress Scale - Stress Subscale Six-month Follow up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Dyadic Coping Inventory - Baseline/Pre-test (Time 1)
timeFrame: Baseline/Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Dyadic Coping Inventory - Post-Test (Time 2)
timeFrame: Post-test: 8 weeks after Pre-Test ; Follow-up: 6 months after Post-Test
measure: Dyadic Coping Inventory - Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Dyadic Coping With Economic Stress Inventory - Baseline/Pre-Test (Time 1)
timeFrame: Baseline/Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Dyadic Coping With Economic Stress Inventory - Post-Test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Dyadic Coping With Economic Stress Inventory - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: The Brief Communication Patterns Questionnaire - General and In Relation to Money Problems - Pre-test (Time 1)
timeFrame: Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: The Brief Communication Patterns Questionnaire - General and In Relation to Money Problems - Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: The Brief Communication Patterns Questionnaire - General and In Relation to Money Problems - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Financial Self-Efficacy Scale - Pre-test (Time 1)
timeFrame: Pre-test (Time1Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Financial Self-Efficacy Scale - Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Financial Self-Efficacy Scale - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Revised Financial Management Behavior Scale - Pre-test (Time 1)
timeFrame: Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Revised Financial Management Behavior Scale - Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Revised Financial Management Behavior Scale - Six-month Follow-up(Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Financial Services Survey From FINRA - Pre-test (Time 1)
timeFrame: Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Financial Services Survey From FINRA - Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Financial Services Survey From FINRA - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Shared Goals and Values - Pre-test (Time 1)
timeFrame: Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Shared Goals and Values - Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Shared Goals and Values - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Couple Financial Management Roles and Satisfaction - Pre-Test (Time 1)
timeFrame: Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Couple Financial Management Roles and Satisfaction - Post-Test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1
measure: Couple Financial Management Roles and Satisfaction - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Perceived Employment Barriers - Pre-test (Time 1)
timeFrame: Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Perceived Employment Barriers - Post--test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Perceived Employment Barriers - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
measure: Employment Hope Scale - Pre-test (Time 1)
timeFrame: Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Employment Hope Scale - Post-test (Time 2)
timeFrame: Post-test (8weeks after pre-test/Time1)
measure: Employment Hope Scale - Six-month Follow-up (Time 3)
timeFrame: Six-month follow up (six months after post-test/Time2)
Secondary outcomes:
Other outcomes:
measure: Experiences in Close Relationships - Post-test (Time 2)
timeFrame: Post-test (8 weeks after pre-test/Time1)
measure: Experience in Close Relationships - Pre-Test (Time 1)
timeFrame: Pre-test (Time 1) (Completed in first workshop session for Intervention Group and int the Intake and Enrollment Meeting for the Control Group)
measure: Experiences in Close Relationships - Follow-up (Time 3)
timeFrame: Follow-up (6 months after Post-test/Time2)
Locations:
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: Gaithersburg
country: United States
facility: Family Services, Inc.
state: Maryland
city: Falls Church
country: United States
facility: Virginia Tech Northern Virginia Center
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Mariana K Falconier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falconier MK. Together - a couples' program to improve communication, coping, and financial management skills: development and initial pilot-testing. J Marital Fam Ther. 2015 Apr;41(2):236-50. doi: 10.1111/jmft.12052. Epub 2014 Jun 9.