NCT02009111

Brief Summary

Couple CARE for Parents is a couple-focused intervention that addresses interpersonal processes within relationships and promotes relationship and parenting skills among couples with a newborn. Couple CARE for Parents uses an approach developed in Australia that was designed to be fairly easy and cost-effective to disseminate widely (i.e., home-visitation and video- and telephone-assisted skills training). It has demonstrated efficacy for significantly enhancing couples' relationship satisfaction in three Australian randomized trials. Arresting the normal decline of satisfaction of new parents to near-clinical levels is noteworthy because relationship dissatisfaction is one of the strongest predictors of partner physical assault. Managing relationship conflict is critical to the health and well-being of both parents and their children. Given the high prevalence of partner physical and emotional aggression (a precursor to the more serious form labeled "intimate partner violence" \[IPV\]) in new parents) among perinatal parents, the need for efficacious prevention services is acute. This randomized, controlled trial will test if couples with a newborn who receive Couple CARE for Parents report significantly less IPV than control couples who do not receive the program. This is a prevention trial. No couple will report ever having experienced IPV. All couples will have three empirically documented risk factors for the development of IPV: youth (each couple will have at least one partner under 30 years of age), parenting a newborn, and psychological aggression in the past year. The project has the following aims: (1) Determine the outcomes of Couple CARE for Parents. The investigators hypothesize that, among other positive outcomes, couples who receive Couple CARE for Parents, compared with those who do not, will report at follow-up (a) less IPV; and (b) less partner physical and emotional aggression. (2) Identify factors that may contribute to reduction in IPV and in physical and emotional aggression (e.g., communication skills, conflict behaviors, parenting expectations, , quality of adult attachment, partner attributions, child abuse potential, family income, marital status, parenting stress, infant difficultness).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
706

participants targeted

Target at P75+ for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

November 2, 2022

Status Verified

December 1, 2013

Enrollment Period

4.8 years

First QC Date

November 15, 2013

Last Update Submit

October 31, 2022

Conditions

Keywords

Transition to parenthoodRelationship intervention

Outcome Measures

Primary Outcomes (3)

  • Conflict Tactics Scale Change from Assessment 1 to Assessment 2

    The CTS2 is a 78-item inventory that assesses the frequency (on 0 - 6 scales labeled from "never" to "more than 20 times") of perpetration of and victimization by partner conflict behaviors in the past 6 months.

    Assessment 1 (0-3 months); Assessment 2 (8 months)

  • Conflict Tactics Scale Change from Assessment 1 to Assessment 3

    The CTS2 is a 78-item inventory that assesses the frequency (on 0 - 6 scales labeled from "never" to "more than 20 times") of perpetration of and victimization by partner conflict behaviors in the past 6 months.

    Assessment 1 (0-3 months); Assessment 3 (15 months)

  • Conflict Tactics Scale Change from Assessment 1 to Assessment 4

    The CTS2 is a 78-item inventory that assesses the frequency (on 0 - 6 scales labeled from "never" to "more than 20 times") of perpetration of and victimization by partner conflict behaviors in the past 12 months.

    Assessment 1 (0-3 months); Assessment 4 (24 months)

Secondary Outcomes (9)

  • Child Abuse Potential Inventory Change from Assessment 1 to Assessment 2

    Assessment 1 (0-3 months); Assessment 2 (8 months)

  • Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 2

    Assessment 1 (0-3 months), Assessment 2 (8 months)

  • Couples Satisfaction Index Change from Assessment 1 to Assessment 2

    Assessment 1 (0-3 months), Assessment 2 (8 months)

  • Child Abuse Potential Inventory Change from Assessment 1 to Assessment 3

    Assessment 1 (0-3 months); Assessment 3 (15 months)

  • Child Abuse Potential Inventory Change from Assessment 1 to Assessment 4

    Assessment 1 (0-3 months); Assessment 4 (24 months)

  • +4 more secondary outcomes

Study Arms (2)

Couple CARE for Parents

EXPERIMENTAL

Couple CARE for Parents is a couple-focused intervention that addresses interpersonal processes within relationships and promotes healthy relationship and parenting skills among couples with a newborn. Couple CARE for Parents uses a highly disseminable model (i.e., home-visitation and video- and telephone-assisted skills training) developed in Australia.

Behavioral: Couple CARE for Parents

Wait-list control

OTHER

The control group will be wait-listed until after the 24-month assessment, at which point they are eligible to receive Couple CARE for Parents (tailored for their children's ages).

Behavioral: Couple CARE for Parents

Interventions

Couple CARE for Parents is a skill-based relationship enhancement program based on a self-regulatory model. It consists of seven sessions and two follow-up booster sessions that occur over the baby's first eight months of life. The first home visit is scheduled 7 - 14 days following recruitment. The next two sessions are scheduled in two week intervals. Sessions 4 through 7 are scheduled in three week intervals. Home visits are expected to last 1.5 to 2 hrs. Out-of-session viewing of the video and completing the exercises typically requires 45 min to 1 hr. The typical phone consultation lasts 15- to 30- min per person. Thus, the program lasts a minimum of 8 to 12 hours. The program will also include two booster sessions (beyond the 8 - 12 hrs).

Couple CARE for ParentsWait-list control

Eligibility Criteria

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

You may qualify if:

  • must be living together
  • must have at least one member aged 30 years or younger
  • must have a baby less than 3 months of age at the time of enrollment
  • must have at least one member who, based on self- or partner-report, has been verbally or psychologically aggressive in the previous six months
  • have two partners able to complete assessments in English
  • have never engaged in intimate partner violence, by both partners' reports

You may not qualify if:

  • Any of the above not met.
  • One member less than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University

New York, New York, 10010, United States

Location

Related Publications (3)

  • Petch JF, Halford WK, Creedy DK, Gamble J. A randomized controlled trial of a couple relationship and coparenting program (Couple CARE for Parents) for high- and low-risk new parents. J Consult Clin Psychol. 2012 Aug;80(4):662-73. doi: 10.1037/a0028781. Epub 2012 Jun 25.

    PMID: 22730950BACKGROUND
  • Halford WK, Sanders MR, Behrens BC. Can skills training prevent relationship problems in at-risk couples? Four-year effects of a behavioral relationship education program. J Fam Psychol. 2001 Dec;15(4):750-68. doi: 10.1037//0893-3200.15.4.750.

    PMID: 11770479BACKGROUND
  • Halford WK; Moore EM; Wilson KL; Dyer C; Farrugia C. Benefits of a flexible delivery relationship education: An evaluation of the Couple CARE program. Fam Relat 2004 June;53:469-476

    BACKGROUND

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2013

First Posted

December 11, 2013

Study Start

March 1, 2008

Primary Completion

December 1, 2012

Last Updated

November 2, 2022

Record last verified: 2013-12

Locations