N/A
N=222
Promotion of Successful Parenting
Pregnant and Parenting Women
Bottom Line
View on ClinicalTrials.gov: NCT03808987 ↗Enrolled (actual)
222
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Parental Sensitivity (Measured With the Parental Bonding Questionnaire) — 120.38; 116.40; 118.70; 118.65 score on a scale — p=.019
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Child-Parent Psychotherapy (CPP) (Behavioral); Community Health Worker (CHW) home visitation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parental Sensitivity (Measured With the Parental Bonding Questionnaire) |
118.80; 116.46; 116.86; 117.85 | .47 |
| PRIMARY Parental Acceptance (Measured With the Parental Acceptance and Rejection Questionnaire) |
64.03; 68.03; 64.09; 65.98 | .10 |
| SECONDARY Parental Sensitivity (Measured With the Parental Bonding Questionnaire) |
118.80; 116.46; 116.86; 117.85 | .47 |
| SECONDARY Parental Acceptance (Measured With the Parental Acceptance and Rejection Questionnaire) |
64.03; 68.03; 64.09; 65.98 | .10 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03808987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.