Promotion of Successful Parenting (NCT03808987) | Clinical Trial Compass
CompletedNot Applicable
Promotion of Successful Parenting
United States222 participantsStarted 2019-02-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parental Sensitivity (Measured With the Parental Bonding Questionnaire)
Timeframe: Assessment at child's age of 9 months
2
Parental Acceptance (Measured With the Parental Acceptance and Rejection Questionnaire)