Relationship Education for Relationship Issues

Overseen By Sejal Barden

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help married or committed couples improve their relationships and advance their careers. It focuses on relationship skills, marriage enhancement, and reducing the likelihood of divorce. Participants will engage in relationship education sessions, either in person or online, using the OurRelationship and PREP programs. Couples living in the greater Orlando area who are in a committed relationship and can participate with their partner might be a good fit for this trial.

As an unphased study, this trial provides a unique opportunity for couples to enhance their relationship skills and career prospects.

Do I have to stop taking my current medications for this trial?

The protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these relationship education programs are safe for participants?

Previous studies have shown that the OurRelationship program has been well-received by participants. This online program helps couples improve their relationships. Research shows it effectively attracts and assists couples without causing major side effects.

For PREP, or the Prevention and Relationship Enhancement Program, studies have shown it is also safe and well-liked. PREP aims to help couples achieve healthy and happy relationships through education and skills training. Evidence supports that it does not lead to significant negative effects.

Both programs focus on enhancing relationship skills and have been used successfully in various settings. Participants generally report positive experiences without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Relationship Education for Relationship Issues trial because it explores innovative ways to support couples facing relationship challenges. Unlike traditional therapy, which often requires in-person sessions with a therapist, this trial tests two unique methods: OurRelationship and PREP. OurRelationship offers online interventions that provide flexibility and accessibility, making it easier for couples to participate from anywhere. PREP, on the other hand, involves in-person sessions designed to enhance communication and problem-solving skills. These approaches could offer more accessible and varied options for couples seeking help, potentially leading to more effective and convenient support compared to conventional methods.

What evidence suggests that this trial's treatments could be effective for relationship issues?

Research has shown that the OurRelationship program, available to participants either in-person or online, can enhance relationship satisfaction for couples. One study found that couples who participated in the program reported significantly better outcomes than those on the waiting list, with noticeable improvements in their relationships. Meanwhile, the PREP (Prevention and Relationship Enhancement Program), another treatment option in this trial, helps couples communicate more effectively and collaborate as a team, fostering healthier relationships. Research involving thousands of couples has proven its success in boosting marital happiness and reducing relationship problems. Evidence supports both programs as effective aids for couples facing relationship challenges. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Project Harmony 2.0 is for couples over the age of 18 who are in a committed relationship and live in the greater Orlando metro area. Both partners must participate together to be eligible.

Inclusion Criteria

Must be in a committed relationship

I will attend the trial with my partner.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 hours of relationship education through either face-to-face or online interventions

4 weeks

Varies based on intervention type (in-person or online)

Follow-up

Participants are monitored for relationship satisfaction and distress using the Revised Dyadic Adjustment Scale

6 months

What Are the Treatments Tested in This Trial?

Interventions

• OurRelationship
• PREP

Trial Overview

The trial tests two programs, PREP and OurRelationship, designed to enhance marital relationships through education and skills training while also offering career advancement opportunities.

How Is the Trial Designed?

Group I: Online Experimental Treatment 1 Intervention

Couples will be assigned into online relationship intervention.

Group II: In person Experimental Treatment 1 Intervention

Couples will be assigned into in person relationship intervention.

OurRelationship is already approved in United States for the following indications:

Approved in United States as OurRelationship Intervention (ORI) for:

• Marriage and relationship education/skills
• Marriage enhancement
• Divorce reduction
• Job and career advancement

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Published Research Related to This Trial

Couple relationship education (RE) has been shown to help maintain relationship satisfaction over time, with 14 out of 17 studies indicating positive effects in couples assessed at least one year after the program.

Couples facing modifiable risk factors see significant benefits from RE, while those with low risk factors or unmodifiable risks may not experience the same advantages, highlighting the need for tailored approaches in relationship education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of relationship education on maintenance of couple relationship satisfaction. Halford, WK., Bodenmann, G.[2013]

The Adverse Drug Reaction (ADR) Prevention Program significantly improved patient knowledge about ADR prevention, with notable differences observed immediately after the program and one month later, based on a study of 65 volunteers.

Healthcare personnel involved in the program reported positive attitudes towards its implementation, indicating a supportive environment for ADR prevention efforts at Rasisalai Hospital in Thailand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of a recurrent Adverse Drug Reaction Prevention Program in the north-east region of Thailand. Chaikoolvatana, A., Chanakit, T., Juengrakpong, A.[2014]

Couples experiencing relationship distress are increasingly attending Couple and Relationship Education (CRE) programs, raising questions about the effectiveness of these programs for this specific group.

The study found that the dosage and duration of participation in CRE programs significantly influence outcomes, suggesting that tailored approaches based on distress levels and time spent in the program are essential for improving effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It's About Time! Examining Received Dosage and Program Duration as Predictors of Change Among Non-Distressed and Distressed Married Couple and Relationship Education Participants. Bradford, AB., Drean, L., Adler-Baeder, F., et al.[2019]

The Patient-Reported Outcomes Measurement Information System (PROMIS) uses advanced item response theory (IRT) to create precise and standardized questionnaires that capture patient health information directly, improving the accuracy of health assessments.

PROMIS physical function instruments have been shown to be superior or at least equal to traditional health assessment tools in terms of clarity, reliability, and sensitivity to change, which can lead to reduced research costs by requiring smaller sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Item response theory, computerized adaptive testing, and PROMIS: assessment of physical function. Fries, JF., Witter, J., Rose, M., et al.[2022]

The PROMIS® Pediatric Family Relationships measure effectively reflects the experiences of family relationships for children with chronic illnesses, as shown through qualitative interviews with 16 parents and 16 children aged 8-17 with conditions like asthma, type 1 diabetes, and sickle cell disease.

Participants generally felt that their family relationship dynamics would remain unchanged even if their child did not have a chronic illness, indicating that the measure captures fundamental aspects of family relationships beyond the impact of illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content validity of the PROMIS® pediatric family relationships measure for children with chronic illness. Flynn, KE., Kliems, H., Saoji, N., et al.[2023]

Couples who participated in a structured communication version of the Prevention and Relationship Education Program (PREP) showed more positive communication behaviors and fewer negative ones at the 6-month follow-up compared to those who did not receive structured communication training.

Both groups of couples experienced a decrease in negative communication patterns, but there was no significant change in overall relationship adjustment, indicating that while communication improved, it did not necessarily translate to a better overall relationship status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dismantling study of prevention and relationship education program: the effects of a structured communication intervention. Owen, J., Manthos, M., Quirk, K.[2013]

In Norway, national authorities and private organizations have successfully made relationship education widely available, but the demographics of attendees remain largely unknown, highlighting a need for better understanding of who is seeking this education.

Preliminary evaluations of the Prevention and Relationship Enhancement Program (PREP) workshops show positive feedback from participants, suggesting that tailoring these programs to the specific needs and cultural contexts of couples could enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A public/private partnership in offering relationship education to the Norwegian population. Thuen, F., Laerum, KT.[2019]

Relationship education programs are designed to help couples reduce distress and the likelihood of divorce, which can have significant personal and social benefits.

For these programs to be effective, they must be evidence-based, attract couples who are at high risk for relationship issues, and address specific factors that contribute to these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best practice in couple relationship education. Halford, WK., Markman, HJ., Kline, GH., et al.[2019]

In a year-long study at a neurology specialty clinic, 40 adverse drug reactions (ADRs) were reported, with the majority (92.5%) identified by pharmacy personnel, highlighting the importance of pharmacists in monitoring drug safety.

None of the reported ADRs required hospitalization, indicating that while the reactions were noted, they were manageable and did not lead to severe complications, supporting the program's role in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with an adverse drug reaction reporting program in a neurology specialty clinic. Ryan, M., Gora-Harper, ML., Caldwell, F.[2018]

About 1 in 200 hospitalized patients experience serious adverse drug effects due to drug-drug interactions (DDIs), highlighting the need for better information and management of these risks.

To improve patient safety, there is a call for enhanced study designs that focus on treatment outcomes, better accessibility to DDI data, and the use of computer-based systems to provide personalized recommendations for managing DDIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in the handling of drug-drug interactions. Fuhr, U.[2018]

A systematic review identified 346 drugs associated with adverse drug reactions (ADRs) that can negatively impact sexual functioning, highlighting a significant concern for patient quality of life and medication adherence.

The most affected drug classes were 'nervous system' (105 drugs) and 'cardiovascular system' (89 drugs), with 16 drugs reporting sexual ADR incidence rates greater than 10%, indicating the need for healthcare professionals to consider these effects in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions on sexual functioning: a systematic overview. Gordijn, R., Teichert, M., Nicolai, MPJ., et al.[2019]

A study of 4,027 adverse drug reaction reports from the French Pharmacovigilance system revealed that 3,303 were serious and often involved multiple drugs, with 36% of cases linked to at least three medications.

Antithrombotic agents were implicated in 34% of serious drug-drug interaction-related adverse reactions, with hemorrhages being the most common type of serious adverse effect, highlighting the need for careful monitoring of drug combinations, especially in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug-Drug Interactions: An Analysis From the French Pharmacovigilance Database. Létinier, L., Ferreira, A., Marceron, A., et al.[2021]

PROMIS® provides a comprehensive set of measures for assessing physical, mental, and social health, designed for both children and adults using advanced psychometric techniques.

The measures are available in fixed-length questionnaires and computerized adaptive tests, with translations in multiple languages, making them accessible for diverse populations in health behavior research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PROMIS®: Standardizing the patient voice in health psychology research and practice. Yount, SE., Cella, D., Blozis, S.[2019]

The PROMIS-PF short form for geriatric rehabilitation (PROMIS-PF-GR) was developed and validated with 207 patients, showing strong content validity and excellent internal consistency (Cronbach's alpha = 0.94).

The PROMIS-PF-GR demonstrated good structural validity, being sufficiently unidimensional and locally independent, making it a reliable tool for measuring physical function in older rehabilitation patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Patient-Reported Outcomes Measurement Information System (PROMIS®) short form for measuring physical function in geriatric rehabilitation patients. Smit, EB., Bouwstra, H., van der Wouden, JC., et al.[2021]

The PROMIS item banks for measuring 'Ability to Participate in Social Roles and Activities' and 'Satisfaction with Social Roles and Activities' were validated in a study with 1002 participants from the Dutch general population, demonstrating strong psychometric properties such as unidimensionality and high reliability (at least 0.90).

These item banks can be effectively used with Computerized Adaptive Testing (CAT), allowing for efficient and precise measurement of social participation with minimal items needed, enhancing user experience and reducing administration time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of two PROMIS item banks for measuring social participation in the Dutch general population. Terwee, CB., Crins, MHP., Boers, M., et al.[2023]

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This study tests the efficacy of the OurRelationship (OR) program, an eight-hour online program adapted from an empirically-based, in-person couple therapy.

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The present pilot study examined the efficacy of a fully web-based relationship intervention for individuals (OR-I).

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Don't feel appreciated by your partner? Relationship ...

Couples assigned to the treatment group in the study participated in one of two online relationship education interventions, OurRelationship and ...