Committed Couple Expecting a ChildNCT03058549
Impact Evaluation of Family Expectations: A Program to Strengthen the Relationships of Disadvantaged Expectant Couples
A study testing Family Expectations in people with Committed Couple Expecting a Child and Parenting, run by Public Strategies at 1 site in United States.
Trial summary
This study investigates the effectiveness of a program to strengthen the relationships of disadvantaged expectant couples, and to increase co-parenting, father involvement, and economic stability. Couples are randomly assigned to Family Expectations or a control group, and assessed at baseline and one year. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Committed Couple Expecting a Child, Parenting, Family Relations
- What is being tested?
- Family Expectations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,640 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both partners are willing to participate
- Partners have a commitment to be together as a couple
- Both partners are the biological parents of a child in a current pregnancy or of a child born within the past 3 months
- Fluent in English (study and intervention materials are in English)
Who cannot join
- 1. Either or both partners have taken part in Family Expectations services before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Expectations: Impact Evaluation of Program for Expectant Couples
This study investigates the effectiveness of a program to strengthen the relationships of disadvantaged expectant couples, and to increase co-parenting, father involvement, and economic stability. Couples are randomly assigned to Family Expectations or a control group, and assessed at baseline and one year.
Read the detailed description
The birth of a child can trigger relationship distress and dissolution. Family Expectations (FE) targets the transition to parenthood as a critical time to help couples focus on family success. Regardless of whether couples are married or unmarried, the goal of FE is to strengthen relationships and advance the well-being of economically disadvantaged couples who are expecting a baby or who are new parents, and to improve the lives of their children. The FE program, including the Becoming Parents (BP) curriculum and supplemental services, is designed to address specific risk factors that affect individual family members and the relationships among them, and to build protective factors that help families avoid, minimize, or manage risks (e.g., individual maladaptation [mother, father, child], couple relationship difficulties, parenting difficulties, and economic insufficiency).
A total of 1,355 couples will be randomly assigned to either Family Expectations (n = 813; 60%) or an untreated control group (n = 542; 40%). Once assigned, participants in the study will complete baseline questions by survey. Those assigned to the FE track will be scheduled for services with the FE intervention team and the control group will not receive the FE intervention. Members of the intervention and control groups will be surveyed both before they are randomly assigned and 12 months later. The study will examine if the Family Expectations program is associated with improved outcomes on relationship quality, stability, parenting quality, father involvement, child wellbeing, and hopefulness about employment.
- Being tested
- Family Expectations
- Keywords
- Expectant parents, Relationship education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family ExpectationsBehavioural
Relationship education and referral services for expectant couples.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Family Expectations | Experimental | Family Expectations includes 36 hours of relationship education and parenting content, coaching sessions for couples, and group case management/referral information about local resources. Each couple will also complete an initial case management assessment, followed by referrals to any needed services, such as employment, substance abuse, mental health, housing, etc. Based on need, couples will have the option of additional case management/coaching services during their involvement in Family Expectations. Receives: Behavioral: Family Expectations |
| Control Group | No intervention | The control group will not receive the intervention though they are able to seek and obtain any services they wish in the community (Treatment as Usual). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship adjustment
This outcome will be measured by a composite of measures to relationship quality (support and affection, global relationship satisfaction, and confidence in the future of the relationship). Respondents will self-report using survey methods.
Measured: Baseline and 1 year post baseline (to assess change over time). Change (or maintenance) relative to control group will be assessed across the two time points.
Relationship stability
Couple remains romantically involved. Self-reported by survey methods.
Measured: 1 year post baseline
Individual wellbeing
Symptoms of depression and anxiety. Respondents will self-report using survey methods.
Measured: Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
Co-parenting quality
The quality of the co-parenting relationship between the expectant partners will be self-reported using survey methods.
Measured: 1 year post baseline.
Child outcomes
Infant temperament and wellbeing will be assessed by parent self-report using survey methods.
Measured: 1 year post baseline.
Interaction quality
This outcome will be measured by a composite of measures that assess communication and conflict management abilities (communication skills, constructive conflict management, destructive conflict management). Respondents will self-report using survey methods.
Measured: Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
Secondary outcomes (1)
Changes in Income
Income will be measured by self-report using survey methods.
Measured: Baseline and 1 year post baseline. Change relative to control group will be assessed across the two time points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jun 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Committed Couple Expecting a ChildStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Strategies
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families, University of Denver
- Responsible party
- Principal investigator, Galena Rhoades, University of Denver
- Investigators
- Galena K Rhoades, Ph.D., Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058549
- Sponsor's protocol ID
- 860135
- Status last verified
- Sep 2020
- First submitted
- 10 Feb 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Expectations: Impact Evaluation of Program for Expectant Couples
- ClinicalTrials.gov ID
- NCT03058549
- Acronym / sponsor ID
- 860135
- Keywords
- Expectant parents, Relationship education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,640 participants (actual)
- Lead sponsor
- Public StrategiesUniversity, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families, University of Denver
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effectiveness of a program to strengthen the relationships of disadvantaged expectant couples, and to increase co-parenting, father involvement, and economic stability. Couples are randomly assigned to Family Expectations or a control group, and assessed at baseline and one year.
Detailed description
The birth of a child can trigger relationship distress and dissolution. Family Expectations (FE) targets the transition to parenthood as a critical time to help couples focus on family success. Regardless of whether couples are married or unmarried, the goal of FE is to strengthen relationships and advance the well-being of economically disadvantaged couples who are expecting a baby or who are new parents, and to improve the lives of their children. The FE program, including the Becoming Parents (BP) curriculum and supplemental services, is designed to address specific risk factors that affect individual family members and the relationships among them, and to build protective factors that help families avoid, minimize, or manage risks (e.g., individual maladaptation [mother, father, child], couple relationship difficulties, parenting difficulties, and economic insufficiency).
A total of 1,355 couples will be randomly assigned to either Family Expectations (n = 813; 60%) or an untreated control group (n = 542; 40%). Once assigned, participants in the study will complete baseline questions by survey. Those assigned to the FE track will be scheduled for services with the FE intervention team and the control group will not receive the FE intervention. Members of the intervention and control groups will be surveyed both before they are randomly assigned and 12 months later. The study will examine if the Family Expectations program is associated with improved outcomes on relationship quality, stability, parenting quality, father involvement, child wellbeing, and hopefulness about employment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Family Expectations | Experimental | Behavioral: Family ExpectationsFamily Expectations includes 36 hours of relationship education and parenting content, coaching sessions for couples, and group case management/referral information about local resources. Each couple will also complete an initial case management assessment, followed by referrals to any needed services, such as employment, substance abuse, mental health, housing, etc. Based on need, couples will have the option of additional case management/coaching services during their involvement in Family Expectations. |
| Control Group | No intervention | –The control group will not receive the intervention though they are able to seek and obtain any services they wish in the community (Treatment as Usual). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both partners are willing to participate
- Partners have a commitment to be together as a couple
- Both partners are the biological parents of a child in a current pregnancy or of a child born within the past 3 months
- Fluent in English (study and intervention materials are in English)
Key exclusion criteria (1 listed)
- 1. Either or both partners have taken part in Family Expectations services before
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 |
|---|---|---|
| Family ExpectationsRelationship education and referral services for expectant couples. | Behavioural | Intervention: Family Expectations |
Primary outcome
Relationship adjustment
Time frame: Baseline and 1 year post baseline (to assess change over time). Change (or maintenance) relative to control group will be assessed across the two time points.
This outcome will be measured by a composite of measures to relationship quality (support and affection, global relationship satisfaction, and confidence in the future of the relationship). Respondents will self-report using survey methods.
Relationship stability
Time frame: 1 year post baseline
Couple remains romantically involved. Self-reported by survey methods.
Individual wellbeing
Time frame: Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
Symptoms of depression and anxiety. Respondents will self-report using survey methods.
Co-parenting quality
Time frame: 1 year post baseline.
The quality of the co-parenting relationship between the expectant partners will be self-reported using survey methods.
Child outcomes
Time frame: 1 year post baseline.
Infant temperament and wellbeing will be assessed by parent self-report using survey methods.
Interaction quality
Time frame: Baseline and 1 year post baseline. Change (or maintenance) relative to control group will be assessed across the two time points.
This outcome will be measured by a composite of measures that assess communication and conflict management abilities (communication skills, constructive conflict management, destructive conflict management). Respondents will self-report using survey methods.
1 secondary outcome
Changes in Income
Time frame: Baseline and 1 year post baseline. Change relative to control group will be assessed across the two time points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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.
Galena K Rhoades, Ph.D. principal investigator
University of Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Expectations in people with Committed Couple Expecting a Child and Parenting, run by Public Strategies at 1 site 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 4 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship adjustment (time frame: Baseline and 1 year post baseline (to assess change over time). Change (or maintenance) relative to control group will be assessed across the two time points.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2020.