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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding Child-Parent Psychotherapy (CPP) to home visits from Community Health Workers (CHWs) can better support parenting and parent-child relationships compared to CHWs alone. The study will examine starting CPP before birth versus after, and whether a 6-month or 12-month duration proves more effective. It targets low-income pregnant women eligible for Medicaid who are already working with a CHW due to high psychosocial risks. As an unphased trial, this study provides a unique opportunity to explore innovative support strategies for enhancing family well-being.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Child-Parent Psychotherapy (CPP) is a safe treatment. Studies have found that children who participated in CPP experienced fewer behavior issues and less stress from trauma. Their mothers reported feeling better overall after the treatment, indicating that CPP is well-received by both children and parents.

For the Community Health Worker (CHW) program, research indicates it helps reduce stress for mothers, especially those facing financial difficulties. The CHW program is associated with better health outcomes for mothers and babies, with no major safety concerns.

Both CPP and CHW programs have demonstrated positive results in studies, suggesting they are safe and helpful. Participants in these programs usually experience improvements without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CPP + CHW Home Visitation program because it offers a unique blend of support that isn't typically found in standard parenting interventions. Unlike traditional approaches that might involve occasional classes or clinic visits, this program provides sustained, personalized support through Community Health Worker home visits. This hands-on approach is complemented by Child-Parent Psychotherapy (CPP), which helps strengthen the parent-child relationship right from the prenatal stage or shortly after birth. This combination aims to offer holistic support, addressing both practical needs and emotional well-being, which could lead to more positive outcomes for families.

What evidence suggests that this trial's treatments could be effective for improving parenting and parent-child relationships?

Research shows that Child-Parent Psychotherapy (CPP) improves the well-being of children and parents at high risk. Studies have found that children in CPP exhibit fewer behavior issues and trauma symptoms. Their mothers also experience less depression and trauma. In this trial, some participants will receive CPP combined with Community Health Worker (CHW) support, starting either prenatally or postnatally, for varying durations. Other participants will receive only CHW support. CHW programs alone have been linked to reduced stress for mothers and improved prenatal care. Combining CPP with CHW support could enhance these benefits by addressing both mental health and practical needs for families. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03808987

NCT03808987 | Promotion of Successful Parenting This preventive treatment evaluation study evaluates whether adding Child-Parent Psychotherapy (CPP) to a Community Health Worker (CHW) outreach model improves ...

2. childparentpsychotherapy.com childparentpsychotherapy.com/wp-content/uploads/2018/01/CPP-research-fact-sheet-Jan-2018.pdf

Research Fact Sheet Outcomes: ➢ For children in the 4+ risk group, those who received CPP showed significantly greater improvements in PTSD and depression symptoms, PTSD diagnosis ...

3. childparentpsychotherapy.com childparentpsychotherapy.com/wp-content/uploads/2018/01/CPP-research-fact-sheet-one-page-Jan-2018.pdf

Research Fact Sheet Summary At post- treatment, CPP children showed significantly greater reductions in total behavior problems and traumatic stress symptoms. CPP mothers showed ...

4. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2807624

Community Health Worker Home Visiting, Birth Outcomes ... Participation in a home visiting program significantly associated with reduced risk of preterm birth (13.3% vs 15.5%), very preterm birth (1.8% vs 3.0%), very ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10916458/

The Role of an Early Childhood Community Health Worker ... Results indicate that families receiving services from the EC-CHW had a decrease in psychosocial stress and an increase in protective factors, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8143430/

Longitudinal Outcomes of Child Parent Psychotherapy We focus on two domains: accessibility and scalability of CPP and identifying empirically supported mechanisms of change in attachment intervention research.

7. cebc4cw.org cebc4cw.org/program/child-parent-psychotherapy/detailed

CEBC » Child Parent Psychotherapy › Program › Detailed The purpose of the study was to assess the treatment outcomes for preschool-age children exposed to marital violence, comparing the efficacy of Infant Parent ...