- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03158714
Alabama Community Healthy Marriage Initiative Evaluation Project for Couples (AHMREI)
The Alabama Healthy Marriage and Relationship Education Initiative
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Auburn, Alabama, United States, 36849
- Auburn University
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Brewton, Alabama, United States, 36426
- Hope Place Family Resource Center
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Decatur, Alabama, United States, 35602
- Parents and Children Together
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Gadsden, Alabama, United States, 35903
- The Family Success Center of Etowah County
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Montgomery, Alabama, United States, 36116
- Family Guidance Center
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Sylacauga, Alabama, United States, 35150
- Sylacauga Alliance for Family Enhancement
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Tuscaloosa, Alabama, United States, 35404
- Tuscaloosa's ONE Place
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Valley, Alabama, United States, 36854
- Circle of Care Center for Families
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Vestavia Hills, Alabama, United States, 35216
- IMPACT Family Counseling
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Wetumpka, Alabama, United States, 36092
- Alabama Cooperative Extension Syestem- Elmore County
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Couples Connecting Mindfully Curriculum
Receives the Couples Connecting Mindfully curriculum over a 6 week period.
|
Other Names:
|
EXPERIMENTAL: ELEVATE Curriculum
Receives the ELEVATE curriculum over a 6 week period.
|
|
NO_INTERVENTION: Control
No programming is offered.
|
What is the study measuring?
Primary Outcome Measures
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.
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6 months
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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.
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8 weeks
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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.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francesca Adler-Baeder, Ph.D., Auburn University
Publications and helpful links
General Publications
- Ware 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.
- Gandek 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16-248 EP 1608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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