Clinical trial NCT02009111: Dyadic, Skills-Based Primary Prevention for Partner Violence in Perinatal Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intimate Partner Violence
Keywords: Transition to parenthood
Relationship intervention
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-12-11
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* Couples are the unit of inclusion. Thus, individuals must be in a relationship. The following criteria are at the couple level.
* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Conflict Tactics Scale Change from Assessment 1 to Assessment 2
timeFrame: Assessment 1 (0-3 months); Assessment 2 (8 months)
measure: Conflict Tactics Scale Change from Assessment 1 to Assessment 3
timeFrame: Assessment 1 (0-3 months); Assessment 3 (15 months)
measure: Conflict Tactics Scale Change from Assessment 1 to Assessment 4
timeFrame: Assessment 1 (0-3 months); Assessment 4 (24 months)
Secondary outcomes:
measure: Child Abuse Potential Inventory Change from Assessment 1 to Assessment 2
timeFrame: Assessment 1 (0-3 months); Assessment 2 (8 months)
measure: Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 2
timeFrame: Assessment 1 (0-3 months), Assessment 2 (8 months)
measure: Couples Satisfaction Index Change from Assessment 1 to Assessment 2
timeFrame: Assessment 1 (0-3 months), Assessment 2 (8 months)
measure: Child Abuse Potential Inventory Change from Assessment 1 to Assessment 3
timeFrame: Assessment 1 (0-3 months); Assessment 3 (15 months)
measure: Child Abuse Potential Inventory Change from Assessment 1 to Assessment 4
timeFrame: Assessment 1 (0-3 months); Assessment 4 (24 months)
measure: Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 3
timeFrame: Assessment 1 (0-3 months); Assessment 3 (15 months)
measure: Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 4
timeFrame: Assessment 1 (0-3 months); Assessment 4 (24 months)
measure: Couples Satisfaction Index Change from Assessment 1 to Assessment 3
timeFrame: Assessment 1 (0-3 months); Assessment 3 (15 months)
measure: Couples Satisfaction Index Change from Assessment 1 to Assessment 4
timeFrame: Assessment 1 (0-3 months); Assessment 4 (24 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References:
citation: 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.
citation: 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.
citation: 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