Prevention of Shaken Baby Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. Our hypothesis is that the Period of PURPLE Crying intervention program can reduce shaking and abuse of infants through changes in knowledge, attitudes and behaviors about early infant crying, especially inconsolable crying. In this 3-year project, we will implement and evaluate an intervention program in selected prenatal classes, hospitals, and primary care pediatric practices.

In this randomized, controlled trial, we will enroll a total of 3000 women/families who are about to give birth or have just given birth to a healthy infant. At each of the three sites (newborn nursery, pediatrician offices and prenatal classes), we will enroll 1000 subjects. Half of all subjects will receive intervention materials (a video, pamphlet and bib/burp cloth) about infant crying. The other half, the control group, will receive comparable materials on infant safety. All subjects will be asked to complete a brief questionnaire at the time of enrollment (pre test), review the materials they receive, complete the Baby's Day Diary for 4 days when the infant is 5 weeks of age and complete a telephone questionnaire (post test) when the infant is 8 weeks of age.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The specific goals of the program are:

1. To change the understanding (i.e., knowledge and attitudes) and reduce the frustration of parents of new infants about the normality of the frustrating properties of crying;
2. To change the behavior of parents to increase caregiving contact in response to crying but to 'walk away' if frustrated;
3. To provide parents with the ability to communicate to other caregivers (relatives, baby-sitters) the knowledge and behavior to reduce frustration induced by inconsolable crying;
4. To provide effective knowledge, skills and teaching materials to health care providers in direct contact with parents concerning crying, shaking and abuse;
5. To reduce the incidence of physical abuse and shaken baby syndrome under one year;
6. To have the Period of PURPLE Crying program adopted as a nationwide early intervention project.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Abuse Shaken Baby Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education about infant crying

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects must be new parents or parents to be who are either: 1) attending participating prenatal classes; 2) delivering a baby at the participating hospital; or 3) visiting a PSPRN (Puget Sound Pediatric Research Network) pediatrician for infant care.
* Only parents of infants born at \> 34 weeks gestation are eligible.

Exclusion Criteria

* Parents of infants who have serious medical conditions.
* Parents who don't speak and read English.
* Parents of infants born at \< 34 weeks gestation.

Minimum Eligible Age

1 Day

Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harborview Injruy Prevention and Research Center

Seattle, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Frederick P Rivara, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Radesky JS, Zuckerman B, Silverstein M, Rivara FP, Barr M, Taylor JA, Lengua LJ, Barr RG. Inconsolable infant crying and maternal postpartum depressive symptoms. Pediatrics. 2013 Jun;131(6):e1857-64. doi: 10.1542/peds.2012-3316. Epub 2013 May 6.

Reference Type DERIVED

PMID: 23650295 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HIPRCSBS-01

Identifier Type: -

Identifier Source: org_study_id