NCT03058549

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3.1 years

First QC Date

February 10, 2017

Last Update Submit

September 14, 2020

Conditions

Committed Couple Expecting a ChildParentingFamily Relations

Keywords

Expectant parentsRelationship education

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    1 year post baseline

  • Individual wellbeing

    Symptoms of depression and anxiety. Respondents will self-report using survey methods.

    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.

    1 year post baseline.

  • Child outcomes

    Infant temperament and wellbeing will be assessed by parent self-report using survey methods.

    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.

    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

    Baseline and 1 year post baseline. Change relative to control group will be assessed across the two time points.

Study Arms (2)

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.

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).

Interventions

Family ExpectationsBEHAVIORAL

Relationship education and referral services for expectant couples.

Intervention: Family Expectations

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • \. Either or both partners have taken part in Family Expectations services before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Strategies

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

  • Galena K Rhoades, Ph.D.

    University of Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 23, 2017

Study Start

June 1, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

US(1)