Pregnant and Parenting WomenPROMISENCT03808987
Promotion of Successful Parenting
A study testing Child-Parent Psychotherapy (CPP) and Community Health Worker (CHW) home visitation in people with Pregnant and Parenting Women, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant and Parenting Women
- What is being tested?
- Child-Parent Psychotherapy (CPP) and Community Health Worker (CHW) home visitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRANSFORM: Translational Research That Adapts New Science FOR Maltreatment Prevention
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.
Read the 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.
- Conditions
- Pregnant and Parenting Women
- Being tested
- Child-Parent Psychotherapy (CPP), Community Health Worker (CHW) home visitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child-Parent Psychotherapy (CPP)Behavioural
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 visitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CHW+CPP brief prenatal onset | Experimental | Participants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning prenatally, in addition to services from a Community Health Worker (CHW) Receives: Behavioral: Child-Parent Psychotherapy (CPP); Behavioral: Community Health Worker (CHW) home visitation |
| CHW+CPP brief postnatal onset | Experimental | Participants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning postnatally, in addition to services from a Community Health Worker (CHW) Receives: Behavioral: Child-Parent Psychotherapy (CPP); Behavioral: Community Health Worker (CHW) home visitation |
| CHW+CPP 12 months | Experimental | Participants will receive Child-Parent Psychotherapy (CPP) for 12 months, beginning prenatally, in addition to services from a Community Health Worker (CHW) Receives: Behavioral: Child-Parent Psychotherapy (CPP); Behavioral: Community Health Worker (CHW) home visitation |
| CHW only | Experimental | Participants will receive services from a Community Health Worker (CHW) without Child-Parent Psychotherapy (CPP) Receives: Behavioral: Community Health Worker (CHW) home visitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Sensitivity (Measured With the Parental Bonding Questionnaire)
Improvements 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.
Measured: Assessment at child's age of 9 months
Parental Acceptance (Measured With the Parental Acceptance and Rejection Questionnaire)
Improvements 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.
Measured: Assessment at child's age of 9 months
Secondary outcomes (2)
Parental Sensitivity (Measured With the Parental Bonding Questionnaire)
Improvements 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.
Measured: Assessment at child's age of 15 months
Parental Acceptance (Measured With the Parental Acceptance and Rejection Questionnaire)
Improvements 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.
Measured: Assessment at child's age of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start21 Feb 2019
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnant and Parenting WomenStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Child-Parent Psychotherapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sheree Toth, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808987
- Sponsor's protocol ID
- 1P50HD096698-01
- Other IDs
- 1P50HD096698-01
- Acronym
- PROMISE
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2019
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSFORM: Translational Research That Adapts New Science FOR Maltreatment Prevention
- ClinicalTrials.gov ID
- NCT03808987
- Acronym / sponsor ID
- PROMISE / 1P50HD096698-01
- Conditions
- Pregnant and Parenting Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Child-Parent Psychotherapy
| Arm | Type | Receives |
|---|---|---|
| CHW+CPP brief prenatal onset | Experimental | Behavioral: Child-Parent Psychotherapy (CPP), Behavioral: Community Health Worker (CHW) home visitationParticipants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning prenatally, in addition to services from a Community Health Worker (CHW) |
| CHW+CPP brief postnatal onset | Experimental | Behavioral: Child-Parent Psychotherapy (CPP), Behavioral: Community Health Worker (CHW) home visitationParticipants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning postnatally, in addition to services from a Community Health Worker (CHW) |
| CHW+CPP 12 months | Experimental | Behavioral: Child-Parent Psychotherapy (CPP), Behavioral: Community Health Worker (CHW) home visitationParticipants will receive Child-Parent Psychotherapy (CPP) for 12 months, beginning prenatally, in addition to services from a Community Health Worker (CHW) |
| CHW only | Experimental | Behavioral: Community Health Worker (CHW) home visitationParticipants will receive services from a Community Health Worker (CHW) without Child-Parent Psychotherapy (CPP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | CHW+CPP 12 months, CHW+CPP brief postnatal onset, CHW+CPP brief prenatal onset |
| Community Health Worker (CHW) home visitationCommunity 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. | Behavioural | CHW only, CHW+CPP 12 months, CHW+CPP brief postnatal onset, CHW+CPP brief prenatal onset |
Primary outcome
Parental Sensitivity (Measured With the Parental Bonding Questionnaire)
Time frame: Assessment at child's age of 9 months
Improvements 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)
Time frame: Assessment at child's age of 9 months
Improvements 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.
2 secondary outcomes
Parental Sensitivity (Measured With the Parental Bonding Questionnaire)
Time frame: Assessment at child's age of 15 months
Parental Acceptance (Measured With the Parental Acceptance and Rejection Questionnaire)
Time frame: Assessment at child's age of 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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 study testing Child-Parent Psychotherapy (CPP) and Community Health Worker (CHW) home visitation in people with Pregnant and Parenting Women, run by University of Rochester 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 1 inclusion and 1 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 14 May 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Parental Sensitivity (Measured With the Parental Bonding Questionnaire) (time frame: Assessment at child's age of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.