Promotion of Successful Parenting

Pregnant and Parenting Women Clinical Trial

— PROMISE  

Official title:

TRANSFORM: Translational Research That Adapts New Science FOR Maltreatment Prevention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03808987
• Other study ID #: 1P50HD096698-01
• Secondary ID: 1P50HD096698-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 children's age of 3, 9, and 12 months.

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 (i.e., beginning prenatally or postnatally), the optimal duration of services (i.e., 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 infant's 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 222
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants will be low-income pregnant adult women eligible for Medicaid and who have been referred to a Community Health Worker program based on their high psychosocial risk status.

Exclusion Criteria:

• Mothers will be excluded if they have significant cognitive limitations, severe psychiatric disorders requiring a higher level of care (e.g., imminent suicidal ideation requiring hospitalization, psychotic features), non-English proficiency, age less than 18, or a physical disability that impedes ability to complete study procedures. Mothers whose psychiatric needs or substance use requires inpatient treatment will be excluded. Mothers will be excluded if they terminate their pregnancy or do not deliver a live birth.

Related Conditions & MeSH terms

• Pregnant and Parenting Women

Intervention

Behavioral:
• Child-Parent Psychotherapy (CPP)
Child-Parent Psychotherapy (CPP) focuses on parent-infant relationships, increases efficacy for improved mother-child relationships, more sensitive parenting, healthier child development, and maltreatment prevention. A primary goal is to strengthen the parent-child relationship to improve family functioning and child security of attachment. Through respect, empathic concern, and positive regard, the therapeutic relationship provides mothers with corrective emotional experiences, through which they are able to differentiate current from past relationships, form positive internal representations of themselves and of themselves in relationship to others, particularly their children. Parents are encouraged to process their experiences of trauma and restore parental roles as protective shields, improve affective regulation capacities, enhance understanding of the meaning of behavior, acknowledge the impact of trauma, and support children in a more positive developmental trajectory.
• Community Health Worker (CHW) home visitation
Community Health Worker (CHW) home visitation includes assistance with concrete support needs, such as transportation to medical appointments, referrals for food, housing, and employment services, and attention to developmental needs of young children.

Locations

Country	Name	City	State
United States	Mt. Hope Family Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental Sensitivity (measured with the Parental Bonding Questionnaire)	Improvements in maternal reports of positive emotional responses to their babies	Assessment at child's age of 9 months
Primary	Parental Acceptance (measured with the Parental Acceptance and Rejection Questionnaire)	Improvements in maternal reports of acceptance in parent-child relationships	Assessment at child's age of 9 months
Secondary	Parental Sensitivity (measured with the Parental Bonding Questionnaire)	Improvements in maternal reports of positive emotional responses to their babies	Assessment at child's age of 15 months
Secondary	Parental Acceptance (measured with the Parental Acceptance and Rejection Questionnaire)	Improvements in maternal reports of acceptance in parent-child relationships	Assessment at child's age of 15 months