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Trial record 41 of 120 for:    (domestic or partner) AND (violence OR abuse)

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

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ClinicalTrials.gov Identifier: NCT02009111
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Amy Slep, New York University School of Medicine

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).


Condition or disease Intervention/treatment Phase
Intimate Partner Violence Behavioral: Couple CARE for Parents Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2008
Actual Primary Completion Date : December 2012

Arm Intervention/treatment
Experimental: Couple CARE for Parents
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
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).

Wait-list control
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
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).




Primary Outcome Measures :
  1. Conflict Tactics Scale Change from Assessment 1 to Assessment 2 [ Time Frame: Assessment 1 (0-3 months); Assessment 2 (8 months) ]
    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.

  2. Conflict Tactics Scale Change from Assessment 1 to Assessment 3 [ Time Frame: Assessment 1 (0-3 months); Assessment 3 (15 months) ]
    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.

  3. Conflict Tactics Scale Change from Assessment 1 to Assessment 4 [ Time Frame: Assessment 1 (0-3 months); Assessment 4 (24 months) ]
    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.


Secondary Outcome Measures :
  1. Child Abuse Potential Inventory Change from Assessment 1 to Assessment 2 [ Time Frame: Assessment 1 (0-3 months); Assessment 2 (8 months) ]
    This 70-item self-report measure contains 70 of the original 77 abuse items.

  2. Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 2 [ Time Frame: Assessment 1 (0-3 months), Assessment 2 (8 months) ]
    This is a 24-item parent-report measure of perceived difficult temperament.

  3. Couples Satisfaction Index Change from Assessment 1 to Assessment 2 [ Time Frame: Assessment 1 (0-3 months), Assessment 2 (8 months) ]
    This is a measure of relationship satisfaction.

  4. Child Abuse Potential Inventory Change from Assessment 1 to Assessment 3 [ Time Frame: Assessment 1 (0-3 months); Assessment 3 (15 months) ]
    This 70-item self-report measure contains 70 of the original 77 abuse items.

  5. Child Abuse Potential Inventory Change from Assessment 1 to Assessment 4 [ Time Frame: Assessment 1 (0-3 months); Assessment 4 (24 months) ]
    This 70-item self-report measure contains 70 of the original 77 abuse items.

  6. Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 3 [ Time Frame: Assessment 1 (0-3 months); Assessment 3 (15 months) ]
    This is a 24-item parent-report measure of perceived difficult temperament.

  7. Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 4 [ Time Frame: Assessment 1 (0-3 months); Assessment 4 (24 months) ]
    This is a 24-item parent-report measure of perceived difficult temperament.

  8. Couples Satisfaction Index Change from Assessment 1 to Assessment 3 [ Time Frame: Assessment 1 (0-3 months); Assessment 3 (15 months) ]
    This is a measure of relationship satisfaction.

  9. Couples Satisfaction Index Change from Assessment 1 to Assessment 4 [ Time Frame: Assessment 1 (0-3 months); Assessment 4 (24 months) ]
    This is a measure of relationship satisfaction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009111


Locations
United States, New York
New York University
New York, New York, United States, 10010
Sponsors and Collaborators
New York University
Centers for Disease Control and Prevention

Publications:
Responsible Party: Amy Slep, Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02009111     History of Changes
Other Study ID Numbers: 7U49CE001246-06 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Amy Slep, New York University School of Medicine:
Transition to parenthood
Relationship intervention