Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03808987
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2019-01-16
Brief Title:
Promotion of Successful Parenting
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
TRANSFORM Translational Research That Adapts New Science FOR Maltreatment Prevention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
Brief Summary:
Home visitation by community health workers is a commonly utilized approach to support families and prevent child maltreatment At times however more intensive intervention is needed to address familial trauma depression or other challenges This preventive treatment evaluation study evaluates whether adding Child-Parent Psychotherapy CPP to a Community Health Worker CHW outreach model improves positive parenting and parent-child relationships above CHW alone The efficacy of CPP has been demonstrated with maltreated and other high-risk populations This evaluation will examine optimal timing of CPP beginning prenatally or postnatally and optimal duration of services 6 vs 12 months Additionally how and for whom CPP is most effective and why will be examined Assessments of parenting maternal sensitivity representational models cognitions physiological reactivity and physical health indicators will be assessed prenatally and at childrens age of 3 9 and 12 months
Detailed Description:
PROMISE is integrated into the TRANSFORM Capstone Center to promote the next generation of research on child maltreatment translate research findings into clinical and preventive interventions and disseminate research and best practice to varied stakeholders Informed by developmental psychopathology the research incorporates multiple levels of analysis within a lifespan framework Increasing knowledge of optimal methods for delivering dual mother and child preventive intervention has crucial public health significance in preventing child maltreatment PROMISE involves a randomized control trial to evaluate whether expanding a Community Health Worker CHW outreach model by adding Child-Parent Psychotherapy CPP an intensive intervention that focuses on parent-infant relationships for families at risk for child maltreatment increases efficacy for improved mother-child relationships more sensitive parenting healthier child development and maltreatment prevention The efficacy of CPP has been demonstrated with maltreated and other high-risk populations Through the use of four intervention arms the evaluation will assess whether more intensive intervention better protects against child maltreatment compared with CHW support alone and will determine the optimal timing of these interventions ie beginning prenatally or postnatally the optimal duration of services ie 6 vs 12 months mechanisms of effect mediator analyses and which intervention strategy works best for mothers with varying risk factors moderator analyses Pregnant women N 300 and their infants after birth will participate Longitudinal assessments will occur during the third trimester of pregnancy at infants ages of 3 and 9 months and a post-intervention follow-up at 15 months old The measurements obtained at each timepoint constitute a rich multi-level perspective of maternal and child functioning over time in response to the interventions Maternal parenting behaviors representational models cognitions and physiological reactivity and infants health and development will be assessed longitudinally CPP groups are hypothesized to improve sensitive and responsive parenting and secure attachment relative to CHW home visitation alone thereby reducing risks for child maltreatment Improvements in maternal attachment representations parenting cognitions and stress reactivity are hypothesized to mediate treatment outcomes Moderators including maternal histories of trauma psychopathology and intimate partner violence will advance determination of differential responsiveness to CHW and CPP what works for whom and why and allow for tailored preventive strategies Identification of timing dosage and intensity of service delivery along with outcome mediators and moderators is innovative and will facilitate development of targeted prevention and intervention strategies that support parenting and decrease child maltreatment for this vulnerable population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P50HD096698-01 | NIH | None | httpsreporternihgovquickSearch1P50HD096698-01 |