Dyadic, Skills-Based Primary Prevention for Partner Violence in Perinatal Parents

Intimate Partner Violence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009111
• Other study ID #: 7U49CE001246-06
• Status: Completed
• Phase: Phase 2
• Start date: March 2008

Study information

• Verified date: December 2013
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

Behavioral:
• Couple CARE for Parents
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).

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Child Abuse Potential Inventory Change from Assessment 1 to Assessment 2	This 70-item self-report measure contains 70 of the original 77 abuse items.	Assessment 1 (0-3 months); Assessment 2 (8 months)
Secondary	Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 2	This is a 24-item parent-report measure of perceived difficult temperament.	Assessment 1 (0-3 months), Assessment 2 (8 months)
Secondary	Couples Satisfaction Index Change from Assessment 1 to Assessment 2	This is a measure of relationship satisfaction.	Assessment 1 (0-3 months), Assessment 2 (8 months)
Secondary	Child Abuse Potential Inventory Change from Assessment 1 to Assessment 3	This 70-item self-report measure contains 70 of the original 77 abuse items.	Assessment 1 (0-3 months); Assessment 3 (15 months)
Secondary	Child Abuse Potential Inventory Change from Assessment 1 to Assessment 4	This 70-item self-report measure contains 70 of the original 77 abuse items.	Assessment 1 (0-3 months); Assessment 4 (24 months)
Secondary	Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 3	This is a 24-item parent-report measure of perceived difficult temperament.	Assessment 1 (0-3 months); Assessment 3 (15 months)
Secondary	Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 4	This is a 24-item parent-report measure of perceived difficult temperament.	Assessment 1 (0-3 months); Assessment 4 (24 months)
Secondary	Couples Satisfaction Index Change from Assessment 1 to Assessment 3	This is a measure of relationship satisfaction.	Assessment 1 (0-3 months); Assessment 3 (15 months)
Secondary	Couples Satisfaction Index Change from Assessment 1 to Assessment 4	This is a measure of relationship satisfaction.	Assessment 1 (0-3 months); Assessment 4 (24 months)