CompletedPhase 1/2

Parents Helping Infants Study: Educational Intervention to Change the Knowledge, Attitudes and Behaviour of New Parents About Early Infant Crying

Canada1,833 participantsStarted 2005-05

Plain-language summary

This research project seeks to implement an early intervention program that can be effective in the prevention of shaken baby syndrome (SBS) and infant abuse. The investigators' hypothesis is that the Period of PURPLE Crying intervention program can be effective in reducing the shaking and abuse of infants through changes in knowledge, attitudes and behaviours about early infant crying, especially inconsolable crying.

Who can participate

Age range

18 Years – 45 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: * New mothers of healthy infants born at \> 34 weeks gestation with access to a video or DVD player. Exclusion Criteria: * Mothers of: infants born at \< 34 weeks gestation; multiple infants (twins, triplets, etc.); or infants who have serious medical conditions. * Mothers who don't speak and read English.

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

To demonstrate the effectiveness of the Period of PURPLE Crying program to change knowledge, attitudes and behavior about early infant crying and shaken baby syndrome in new parents at two months of life

Timeframe: Two months

Trial details

NCT IDNCT00175422

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-01

View on ClinicalTrials.gov More Shaken Baby Syndrome trials