Pediatric Parenting Support in Flint (NCT03945552) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pediatric Parenting Support in Flint
United States486 participantsStarted 2019-07-23
Plain-language summary
Public health disasters have disproportionate impacts on low income communities, through pathways that add to those of poverty and associated stressors, and act over extended periods. Very young children are highly vulnerable to long-term impacts on development and mental health in the context of parenting challenges following disasters, yet frequently receive the least attention and resources. This study will test the role of universal parenting support in enhancing young children's development and mental health in Flint, Michigan following the Flint Water Crisis.
Who can participate
Sex
ALL
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:
* Infant is receiving pediatric care at Hurley Children's Clinic
* Caregiver can be contacted (has a working phone)
* Infant is three months old or younger at time of enrollment
Exclusion Criteria:
* Infant very low birth weight (\<1500gm)
* Infant born in non-singleton birth (twin, triplet, etc.)
* Infant has known or suspected significant genetic syndrome or malformation
* Infant has other significant medical or developmental complication or risk (e.g., known neurodevelopmental/neuromuscular disorder likely to affect development)
* Parent/legal guardian not present with infant at visit and/or unable to provide consent
* Parent/legal guardian is not English speaking
* Parent/legal guardian with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia)
* Parent/legal guardian has previously participated in VIP intervention with another child
* Not planning to stay in Flint area for at least 3 years
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.