CPP + CHW Home Visitation for Parenting Support

(PROMISE Trial)

Overseen By Jody T Manly, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Cognitive limitations, Severe psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 months

222 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for low-income pregnant women on Medicaid at high psychosocial risk. They must be adults and speak English, without severe psychiatric disorders, cognitive limitations, or physical disabilities that would prevent participation in study procedures.

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 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Child-Parent Psychotherapy (CPP) and Community Health Worker (CHW) services, with variations in timing and duration (6 or 12 months, prenatal or postnatal onset)

6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at child's age of 15 months

3 months

Treatment Details

Interventions

• Child-Parent Psychotherapy (CPP)
• Community Health Worker (CHW) home visitation

Trial Overview The study tests if adding Child-Parent Psychotherapy (CPP) to Community Health Worker (CHW) home visits helps improve parenting and parent-child relationships more than CHW visits alone. It explores the best timing for starting CPP and whether a longer duration of service is beneficial.

Participant Groups

Group I: CHW+CPP brief prenatal onset Experimental Treatment 2 Interventions

Participants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning prenatally, in addition to services from a Community Health Worker (CHW)

Group II: CHW+CPP brief postnatal onset Experimental Treatment 2 Interventions

Participants will receive Child-Parent Psychotherapy (CPP) for 6 months, beginning postnatally, in addition to services from a Community Health Worker (CHW)

Group III: CHW+CPP 12 months Experimental Treatment 2 Interventions

Participants will receive Child-Parent Psychotherapy (CPP) for 12 months, beginning prenatally, in addition to services from a Community Health Worker (CHW)

Group IV: CHW only Experimental Treatment 1 Intervention

Participants will receive services from a Community Health Worker (CHW) without Child-Parent Psychotherapy (CPP)

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+