Promotion of Successful Parenting

NCT03808987 | Completed DMC

• 1 other identifier: 1P50HD096698-01
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant and Parenting Women

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Parental Sensitivity (measured with the Parental Bonding Questionnaire)

  Assessment at child's age of 15 months

• Parental Acceptance (measured with the Parental Acceptance and Rejection Questionnaire)

  Assessment at child's age of 15 months

Study Arms (4)

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)

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)

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)

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)

Behavioral: Community Health Worker (CHW) home visitation

Interventions

Child-Parent Psychotherapy (CPP) BEHAVIORAL

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.

CHW+CPP 12 months; CHW+CPP brief postnatal onset; CHW+CPP brief prenatal onset

Community Health Worker (CHW) home visitation BEHAVIORAL

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.

CHW only; CHW+CPP 12 months; CHW+CPP brief postnatal onset; CHW+CPP brief prenatal onset

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Enrollment will include pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Mt. Hope Family Center

Rochester, New York, 14608, United States

Location

MeSH Terms

Interventions

Community Health Workers

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants will be blind to the arm the participant has been randomly assigned to and to study hypotheses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mt. Hope Family Center

Model Details: Child-Parent Psychotherapy

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: February 21, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 29, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)