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Promotion of Successful Parenting

TRANSFORM: Translational Research That Adapts New Science FOR Maltreatment Prevention

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03808987
Acronym
PROMISE
Enrollment
222
Registered
2019-01-18
Start date
2019-02-21
Completion date
2024-12-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant and Parenting Women

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 children's 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 (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.

Interventions

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.

BEHAVIORALCommunity 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Research assistants will be blind to the arm the participant has been randomly assigned to and to study hypotheses.

Intervention model description

Child-Parent Psychotherapy

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Parental Sensitivity (Measured With the Parental Bonding Questionnaire)Assessment at child's age of 9 monthsImprovements in maternal reports of positive emotional responses to their babies; Parental Bonding Questionnaire, 25 items, each item ranges 0-5 (never to always); higher scores indicate greater bonding or more mother-reports emotional bond with her baby; total score=sum score utilized, range 0-125.
Parental Acceptance (Measured With the Parental Acceptance and Rejection Questionnaire)Assessment at child's age of 9 monthsImprovements in maternal reports of acceptance in parent-child relationships, Parental Acceptance and Rejection Questionnaire, scale assessing parental warmth/affection, indifference/neglect, and rejection; higher scores indicate more challenge, total score=sum score utilized; scale range 1-4 (almost never true to almost always true), range 55 - 220.

Secondary

MeasureTime frameDescription
Parental Sensitivity (Measured With the Parental Bonding Questionnaire)Assessment at child's age of 15 monthsImprovements in maternal reports of positive emotional responses to their babies; Parental Bonding Questionnaire, 25 items, each item ranges 0-5 (never to always); higher scores indicate greater bonding or more mother-reports emotional bond with her baby; total score=sum score utilized, range 0-125.
Parental Acceptance (Measured With the Parental Acceptance and Rejection Questionnaire)Assessment at child's age of 15 monthsImprovements in maternal reports of acceptance in parent-child relationships; Parental Acceptance and Rejection Questionnaire, scale assessing parental warmth/affection, indifference/neglect, and rejection; higher scores indicate more challenge, total score=sum score utilized; scale range 1-4 (almost never true to almost always true), range 55 - 220.

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous28.34 years
STANDARD_DEVIATION 6.05
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
115 Participants
Race (NIH/OMB)
More than one race
10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants
Race (NIH/OMB)
White
10 Participants
Region of Enrollment
United States
63 participants
Sex: Female, Male
Female
46 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 460 / 560 / 570 / 63
other
Total, other adverse events
0 / 460 / 560 / 570 / 63
serious
Total, serious adverse events
0 / 460 / 560 / 570 / 63

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026