Intimate Partner ViolencePhase 2NCT02009111
Dyadic, Skills-Based Primary Prevention for Partner Violence in Perinatal Parents
A Phase 2 study testing Couple CARE for Parents in people with Intimate Partner Violence, run by New York University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Couple CARE for Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any of the above not met.
- One member less than 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Conditions
- Intimate Partner Violence
- Being tested
- Couple CARE for Parents
- Keywords
- Transition to parenthood, Relationship intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple CARE for ParentsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Couple CARE for Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessment 1 (0-3 months); Assessment 4 (24 months)
Secondary outcomes (9)
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.
Measured: Assessment 1 (0-3 months); Assessment 2 (8 months)
Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 2
This is a 24-item parent-report measure of perceived difficult temperament.
Measured: Assessment 1 (0-3 months), Assessment 2 (8 months)
Couples Satisfaction Index Change from Assessment 1 to Assessment 2
This is a measure of relationship satisfaction.
Measured: Assessment 1 (0-3 months), Assessment 2 (8 months)
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.
Measured: Assessment 1 (0-3 months); Assessment 3 (15 months)
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.
Measured: Assessment 1 (0-3 months); Assessment 4 (24 months)
Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 3
This is a 24-item parent-report measure of perceived difficult temperament.
Measured: Assessment 1 (0-3 months); Assessment 3 (15 months)
Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 4
This is a 24-item parent-report measure of perceived difficult temperament.
Measured: Assessment 1 (0-3 months); Assessment 4 (24 months)
Couples Satisfaction Index Change from Assessment 1 to Assessment 3
This is a measure of relationship satisfaction.
Measured: Assessment 1 (0-3 months); Assessment 3 (15 months)
Couples Satisfaction Index Change from Assessment 1 to Assessment 4
This is a measure of relationship satisfaction.
Measured: Assessment 1 (0-3 months); Assessment 4 (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startMar 2008
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009111
- Sponsor's protocol ID
- 7U49CE001246-06
- Status last verified
- Dec 2013
- First submitted
- 15 Nov 2013
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22730950Halford 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.
PubMed 11770479Halford 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic, Skills-Based Primary Prevention for Partner Violence in Perinatal Parents
- ClinicalTrials.gov ID
- NCT02009111
- Acronym / sponsor ID
- 7U49CE001246-06
- Conditions
- Intimate Partner Violence
- Keywords
- Transition to parenthood, Relationship intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2008
- Primary completion
- Dec 2012 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple CARE for Parents | Experimental | Behavioral: Couple CARE for ParentsCouple 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. |
| Wait-list control | Other | Behavioral: Couple CARE for ParentsThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Any of the above not met.
- One member less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple CARE for ParentsCouple 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). | Behavioural | Couple CARE for Parents, Wait-list control |
Primary outcome
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.
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.
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.
9 secondary outcomes
Child Abuse Potential Inventory Change from Assessment 1 to Assessment 2
Time frame: Assessment 1 (0-3 months); Assessment 2 (8 months)
Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 2
Time frame: Assessment 1 (0-3 months), Assessment 2 (8 months)
Couples Satisfaction Index Change from Assessment 1 to Assessment 2
Time frame: Assessment 1 (0-3 months), Assessment 2 (8 months)
Child Abuse Potential Inventory Change from Assessment 1 to Assessment 3
Time frame: Assessment 1 (0-3 months); Assessment 3 (15 months)
Child Abuse Potential Inventory Change from Assessment 1 to Assessment 4
Time frame: Assessment 1 (0-3 months); Assessment 4 (24 months)
Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 3
Time frame: Assessment 1 (0-3 months); Assessment 3 (15 months)
Infant Difficultness Questionnaire Change from Assessment 1 to Assessment 4
Time frame: Assessment 1 (0-3 months); Assessment 4 (24 months)
Couples Satisfaction Index Change from Assessment 1 to Assessment 3
Time frame: Assessment 1 (0-3 months); Assessment 3 (15 months)
Couples Satisfaction Index Change from Assessment 1 to Assessment 4
Time frame: Assessment 1 (0-3 months); Assessment 4 (24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 22730950Petch 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.
- Background: PubMed 11770479Halford 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.
- BackgroundHalford 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Couple CARE for Parents in people with Intimate Partner Violence, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conflict Tactics Scale Change from Assessment 1 to Assessment 2 (time frame: Assessment 1 (0-3 months); Assessment 2 (8 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02009111, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.