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

1800 Participants Needed

Trial Summary

What is the purpose of this trial?

Project Harmony directly addresses prioritized areas identified by Administration of Children and Families, emphasizing healthy marriage promotion activities and career advancement opportunities for adults. Included in service provisions are elements of: \[a\] marriage and relationship education/skills, \[b\] marriage enhancement, \[c\] divorce reduction and \[d\] job and career advancement. The targeted service population for Project Harmony includes married/committed couples in the greater Orlando metro area.

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 data supports the idea that Relationship Education for Relationship Issues is an effective treatment?

The available research does not provide specific data on the effectiveness of Relationship Education for Relationship Issues. Instead, it focuses on the Patient-Reported Outcomes Measurement Information System (PROMIS), which is used to measure health outcomes in various contexts. There is no direct comparison or data provided about the effectiveness of Relationship Education for Relationship Issues compared to other treatments. ^{1 2 3 4 5}

What safety data exists for the Relationship Education treatment?

The provided research does not contain any safety data related to the Relationship Education treatment or its variants like OurRelationship, ORI, PREP, or WOR. The studies focus on adverse drug reactions and drug-drug interactions, which are unrelated to the safety of relationship education programs. ^{6 7 8 9 10}

Is the treatment OurRelationship, PREP a promising treatment for relationship issues?

Yes, the OurRelationship, PREP treatment is promising for relationship issues. It helps improve communication between couples, maintains relationship satisfaction, and is positively evaluated by participants. It is especially beneficial for couples with certain risk factors. ^{11 12 13 14 15}

Eligibility Criteria

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 am 18 years old or older.

I will attend the trial with my partner.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

PROMIS®: Standardizing the patient voice in health psychology research and practice. [2019]

2. Netherlands 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. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Validation of two PROMIS item banks for measuring social participation in the Dutch general population. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Item response theory, computerized adaptive testing, and PROMIS: assessment of physical function. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Content validity of the PROMIS® pediatric family relationships measure for children with chronic illness. [2023]

6. Thailand pubmed.ncbi.nlm.nih.gov

The evaluation of a recurrent Adverse Drug Reaction Prevention Program in the north-east region of Thailand. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions on sexual functioning: a systematic overview. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Experience with an adverse drug reaction reporting program in a neurology specialty clinic. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Spontaneous Reports of Serious Adverse Drug Reactions Resulting From Drug-Drug Interactions: An Analysis From the French Pharmacovigilance Database. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Dismantling study of prevention and relationship education program: the effects of a structured communication intervention. [2013]

12. United States 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. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Effects of relationship education on maintenance of couple relationship satisfaction. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

A public/private partnership in offering relationship education to the Norwegian population. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Best practice in couple relationship education. [2019]