Alabama Community Healthy Marriage Initiative Evaluation Project for Couples (AHMREI)

February 14, 2025 updated by: Francesca Adler-Baeder, Auburn University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1858

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849
        • Auburn University
      • Brewton, Alabama, United States, 36426
        • Hope Place Family Resource Center
      • Decatur, Alabama, United States, 35602
        • Parents and Children Together
      • Gadsden, Alabama, United States, 35903
        • The Family Success Center of Etowah County
      • Montgomery, Alabama, United States, 36116
        • Family Guidance Center
      • Sylacauga, Alabama, United States, 35150
        • Sylacauga Alliance for Family Enhancement
      • Tuscaloosa, Alabama, United States, 35404
        • Tuscaloosa's ONE Place
      • Valley, Alabama, United States, 36854
        • Circle of Care Center for Families
      • Vestavia Hills, Alabama, United States, 35216
        • IMPACT Family Counseling
      • Wetumpka, Alabama, United States, 36092
        • Alabama Cooperative Extension Syestem- Elmore County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Does not meet the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Couples Connecting Mindfully Curriculum
Receives the Couples Connecting Mindfully curriculum over a 6 week period.
Behavioral: Couples Connecting Mindfully
Other Names:
  • CCM
Experimental: ELEVATE Curriculum
Receives the ELEVATE curriculum over a 6 week period.
Behavioral: ELEVATE
No Intervention: Control
No programming is offered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
8 weeks
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Auburn University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Health and Human Services
Mathematica Policy Research, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francesca Adler-Baeder, Ph.D., Auburn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-248 EP 1608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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