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CPP + CHW Home Visitation for Parenting Support (PROMISE Trial)
N/A
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment at child's age of 15 months
Awards & highlights
PROMISE Trial Summary
This trial is testing whether adding Child-Parent Psychotherapy to the outreach model of a Community Health Worker improves positive parenting and parent-child relationships.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves psychotherapy and home visitation rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort discussing personal issues during therapy sessions.
PROMISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessment at child's age of 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessment at child's age of 15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Parental Acceptance (measured with the Parental Acceptance and Rejection Questionnaire)
Parental Sensitivity (measured with the Parental Bonding Questionnaire)
PROMISE Trial Design
4Treatment groups
Experimental Treatment
Group I: CHW+CPP brief prenatal onsetExperimental Treatment2 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 onsetExperimental Treatment2 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 monthsExperimental Treatment2 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 onlyExperimental Treatment1 Intervention
Participants will receive services from a Community Health Worker (CHW) without Child-Parent Psychotherapy (CPP)
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Who is running the clinical trial?
University of RochesterLead Sponsor
836 Previous Clinical Trials
517,946 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,519 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a mother over 18, speak English, mentally stable, and physically able to participate.
Research Study Groups:
This trial has the following groups:- Group 1: CHW+CPP brief prenatal onset
- Group 2: CHW+CPP brief postnatal onset
- Group 3: CHW+CPP 12 months
- Group 4: CHW only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are participating in this clinical experiment?
"Affirmative, clinicaltrials.gov's information reveals that this medical trial is presently recruiting patients. This research project was initially posted on February 21st 2019 and subsequently updated on January 4th 2022 demanding 300 participants from a single site."
Answered by AI
Are there any vacancies for this clinical trial at the moment?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is actively recruiting participants, with the initial posting occuring on February 21st 2019 and the most recent alteration taking place January 4th 2022. 300 individuals need to be recruited from 1 centre for participation in this study."
Answered by AI
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