Healthy MarriageAHMREINCT03158714
Alabama Community Healthy Marriage Initiative Evaluation Project for Couples
A study testing Couples Connecting Mindfully and ELEVATE in people with Healthy Marriage and Healthy Relationship, run by Auburn University at 10 sites in United States.
Trial summary
The Alabama Healthy Marriage and Relationship Education Initiative (AHMREI), a large-scale partnership among Auburn University and 9 additional implementation partners at Family Resource Centers, implements multiple program activities that respond to family needs and integrate comprehensive services to promote healthy… Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Marriage, Healthy Relationship
- What is being tested?
- Couples Connecting Mindfully and ELEVATE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,858 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 Aug 2016to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for the AHRMEI Couples Evaluation Project, the applicant must be part of a couple (as defined by the couple) in which both couple members are applying to the program and that: both members of the couple are 19 years of age or older, both members of the couple can attend the majority of the class offerings.
Who cannot join
- Does not meet the inclusion criteria.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Auburn University
Auburn, Alabama, 36849
Hope Place Family Resource Center
Brewton, Alabama, 36426
Parents and Children Together
Decatur, Alabama, 35602
The Family Success Center of Etowah County
Gadsden, Alabama, 35903
Family Guidance Center
Montgomery, Alabama, 36116
Sylacauga Alliance for Family Enhancement
Sylacauga, Alabama, 35150
Tuscaloosa's ONE Place
Tuscaloosa, Alabama, 35404
Circle of Care Center for Families
Valley, Alabama, 36854
IMPACT Family Counseling
Vestavia Hills, Alabama, 35216
Alabama Cooperative Extension Syestem- Elmore County
Wetumpka, Alabama, 36092
About this study
Official title: The Alabama Healthy Marriage and Relationship Education Initiative
The Alabama Healthy Marriage and Relationship Education Initiative (AHMREI), a large-scale partnership among Auburn University and 9 additional implementation partners at Family Resource Centers, implements multiple program activities that respond to family needs and integrate comprehensive services to promote healthy marriages and relationships, as authorized by the Claims Resolution Act of 2010 (Pub. L. 111-291). The purpose of this study is to evaluate the efficacy of two selected couples education curricula- Elevate and Couples Connecting Mindfully. The programs are intended to improve the well-being of individuals, couples, and families in domains such as couple well-being, parenting skills, individual skills, and economic stability.
Read the detailed description
In 2015, Congress provided funding for grants to provide healthy marriage and relationship services to help interested couples enhance or improve adult and family relationships. The Administration for Children and Families (ACF), within the Department of Health and Human Services (HHS), oversees these grants and provides supports to assist grantees in meeting their goals and objectives. To learn about the implementation and effects of these programs, Dr. Francesca Adler-Baeder at Auburn University was awarded a contract to conduct a local impact evaluation study. The evaluation includes impact and process studies for couples education curricula.
Couples who are eligible for the programs and agree to be in the study are randomly assigned to either one of two program groups (Elevate or Couples Connecting Mindfully) or a no-program control group. Program group members are offered program services; control group members are not offered those services. The impact study will examine whether the programs improve outcomes for individuals in couples and the children of the participants in the program group compared to outcomes of those in the control group. Members of both program and control groups are surveyed five times over 2 years: before they are randomly assigned, immediately after the curricula have been implemented (approximately 8 weeks later), and 6 months, 1 year, and 2 years after baseline. All surveys are administered via an online survey system, Qualtrics. The survey covers a range of questions related to couple relationships and interactions, individual functioning, parent-child interactions, co-parenting quality, and economic stability. The process aspect of the study will examine multiple aspects of the implementation and operation of the programs. Specifically, program attendance or dose, participant characteristics, facilitator-participant relationship, attitudes towards the program, and mechanisms of change will be considered in the process evaluation. Information for the process evaluation is obtained through the respondents' online surveys and facilitator/educator surveys.
- Conditions
- Healthy Marriage, Healthy Relationship
- Being tested
- Couples Connecting Mindfully, ELEVATE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples Connecting MindfullyBehavioural
Also called CCM
ELEVATEBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Couples Connecting Mindfully Curriculum | Experimental | Receives the Couples Connecting Mindfully curriculum over a 6 week period. Receives: Behavioral: Couples Connecting Mindfully |
| ELEVATE Curriculum | Experimental | Receives the ELEVATE curriculum over a 6 week period. Receives: Behavioral: ELEVATE |
| Control | No intervention | No programming is offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Couple Satisfaction Index
Couple satisfaction was measured using an abbreviated version of the Couple Satisfaction Index utilized in previously published studies. The 3 items (rated from 1 [Not at all] to 6 [Completely]) are: "I have a warm and comfortable relationship with my partner," "How rewarding is your relationship with your partner?" and "In general, how satisfied are you with your relationship?" Mean composites were calculated, and the total scale ranges from 1 to 6. Higher scores indicate higher couple satisfaction.
Measured: 6 months
The Couple Relationship Skills Inventory
Couple relationship skills were measured using 32 items from the Couple Relationship Skills Inventory (CRSI). This measure was constructed to match the core relationship skills and predictors of couple quality emphasized in the HMRE programs provided. Items were taken from established and validated social science measures assessing commitment, intimate partner knowledge, friendship, caring behaviors, conflict management, and external support. Example items include, "I commit effort every day to making my relationship work," "I know my partner's current life stresses," "When things 'get heated' I suggest we take a break to calm down," and "I initiate physical affection with my partner." Items ranged from 1 (Very strongly disagree) to 7 (Very strongly agree). Composite sum scores were created at the individual level and the total scale ranges from 1-224 (i.e., 32*7 = 224). Higher scores indicate greater couple relationship skills.
Measured: 8 weeks
Individual Mental Health
Individual mental health was measured using the SF-12 Mental Component Summary score assessing anxiety, depression, sense of wellbeing, and social/emotional functioning. Per the measure's design, items were asked on differing scales (e.g., 1 to 3 or 1 to 5) with different anchor responses (e.g., all of the time to none of the time, or not at all to extremely). Example items include, "During the past month how much of the time have you accomplished less than you would like" or "During the past month how often have you felt downhearted and depressed?" The SF-12 Mental Component Summary score has shown scale reliability and validity in empirical studies. Scores range from 0 to 100 with a mean of 50 and SD of 10 in the general U.S. population. Higher scores indicate better individual mental health.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start11 Aug 2016
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy MarriageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,858 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Mathematica Policy Research, Inc., Department of Health and Human Services
- Responsible party
- Principal investigator, Francesca Adler-Baeder, Auburn University
- Investigators
- Francesca Adler-Baeder, Ph.D., Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158714
- Sponsor's protocol ID
- 16-248 EP 1608
- Acronym
- AHMREI
- Status last verified
- Feb 2025
- First submitted
- 5 May 2017
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.
PubMed 18179329Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
PubMed 9817135Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alabama Healthy Marriage and Relationship Education Initiative
- ClinicalTrials.gov ID
- NCT03158714
- Acronym / sponsor ID
- AHMREI / 16-248 EP 1608
- Conditions
- Healthy Marriage, Healthy Relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,858 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Mathematica Policy Research, Inc., Department of Health and Human Services
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 14 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Alabama Healthy Marriage and Relationship Education Initiative (AHMREI), a large-scale partnership among Auburn University and 9 additional implementation partners at Family Resource Centers, implements multiple program activities that respond to family needs and integrate comprehensive services to promote healthy marriages and relationships, as authorized by the Claims Resolution Act of 2010 (Pub. L. 111-291). The purpose of this study is to evaluate the efficacy of two selected couples education curricula- Elevate and Couples Connecting Mindfully. The programs are intended to improve the well-being of individuals, couples, and families in domains such as couple well-being, parenting skills, individual skills, and economic stability.
Detailed description
In 2015, Congress provided funding for grants to provide healthy marriage and relationship services to help interested couples enhance or improve adult and family relationships. The Administration for Children and Families (ACF), within the Department of Health and Human Services (HHS), oversees these grants and provides supports to assist grantees in meeting their goals and objectives. To learn about the implementation and effects of these programs, Dr. Francesca Adler-Baeder at Auburn University was awarded a contract to conduct a local impact evaluation study. The evaluation includes impact and process studies for couples education curricula.
Couples who are eligible for the programs and agree to be in the study are randomly assigned to either one of two program groups (Elevate or Couples Connecting Mindfully) or a no-program control group. Program group members are offered program services; control group members are not offered those services. The impact study will examine whether the programs improve outcomes for individuals in couples and the children of the participants in the program group compared to outcomes of those in the control group. Members of both program and control groups are surveyed five times over 2 years: before they are randomly assigned, immediately after the curricula have been implemented (approximately 8 weeks later), and 6 months, 1 year, and 2 years after baseline. All surveys are administered via an online survey system, Qualtrics. The survey covers a range of questions related to couple relationships and interactions, individual functioning, parent-child interactions, co-parenting quality, and economic stability. The process aspect of the study will examine multiple aspects of the implementation and operation of the programs. Specifically, program attendance or dose, participant characteristics, facilitator-participant relationship, attitudes towards the program, and mechanisms of change will be considered in the process evaluation. Information for the process evaluation is obtained through the respondents' online surveys and facilitator/educator surveys.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Couples Connecting Mindfully Curriculum | Experimental | Behavioral: Couples Connecting MindfullyReceives the Couples Connecting Mindfully curriculum over a 6 week period. |
| ELEVATE Curriculum | Experimental | Behavioral: ELEVATEReceives the ELEVATE curriculum over a 6 week period. |
| Control | No intervention | –No programming is offered. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible for the AHRMEI Couples Evaluation Project, the applicant must be part of a couple (as defined by the couple) in which both couple members are applying to the program and that: both members of the couple are 19 years of age or older, both members of the couple can attend the majority of the class offerings.
Key exclusion criteria (1 listed)
- Does not meet the inclusion criteria.
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 |
|---|---|---|
| Couples Connecting MindfullyAlso: CCM | Behavioural | Couples Connecting Mindfully Curriculum |
| ELEVATE | Behavioural | ELEVATE Curriculum |
Primary outcome
Couple Satisfaction Index
Time frame: 6 months
Couple satisfaction was measured using an abbreviated version of the Couple Satisfaction Index utilized in previously published studies. The 3 items (rated from 1 [Not at all] to 6 [Completely]) are: "I have a warm and comfortable relationship with my partner," "How rewarding is your relationship with your partner?" and "In general, how satisfied are you with your relationship?" Mean composites were calculated, and the total scale ranges from 1 to 6. Higher scores indicate higher couple satisfaction.
The Couple Relationship Skills Inventory
Time frame: 8 weeks
Couple relationship skills were measured using 32 items from the Couple Relationship Skills Inventory (CRSI). This measure was constructed to match the core relationship skills and predictors of couple quality emphasized in the HMRE programs provided. Items were taken from established and validated social science measures assessing commitment, intimate partner knowledge, friendship, caring behaviors, conflict management, and external support. Example items include, "I commit effort every day to making my relationship work," "I know my partner's current life stresses," "When things 'get heated' I suggest we take a break to calm down," and "I initiate physical affection with my partner." Items ranged from 1 (Very strongly disagree) to 7 (Very strongly agree). Composite sum scores were created at the individual level and the total scale ranges from 1-224 (i.e., 32*7 = 224). Higher scores indicate greater couple relationship skills.
Individual Mental Health
Time frame: 6 months
Individual mental health was measured using the SF-12 Mental Component Summary score assessing anxiety, depression, sense of wellbeing, and social/emotional functioning. Per the measure's design, items were asked on differing scales (e.g., 1 to 3 or 1 to 5) with different anchor responses (e.g., all of the time to none of the time, or not at all to extremely). Example items include, "During the past month how much of the time have you accomplished less than you would like" or "During the past month how often have you felt downhearted and depressed?" The SF-12 Mental Component Summary score has shown scale reliability and validity in empirical studies. Scores range from 0 to 100 with a mean of 50 and SD of 10 in the general U.S. population. Higher scores indicate better individual mental health.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18179329Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.
- Background: PubMed 9817135Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
- Background: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Individual participant dataSharing planned: No
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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.
Francesca Adler-Baeder, Ph.D. principal investigator
Auburn University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples Connecting Mindfully and ELEVATE in people with Healthy Marriage and Healthy Relationship, run by Auburn University at 10 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 1 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Yes. Results are posted in the registry (first posted 14 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Couple Satisfaction Index (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158714, which also lists 3 linked publications.
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 19 Feb 2025.