Child AbuseNCT00105963

Prevention of Shaken Baby Syndrome

A study testing Education about infant crying in people with Child Abuse and Shaken Baby Syndrome, run by Harborview Injury Prevention and Research Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 1 day to 4 weeksHealthy volunteers can take part
Conditions the study is for: Child Abuse, Shaken Baby Syndrome
What is being tested?: Education about infant crying
Type of treatment: Lifestyle or therapy programme
How many people: 3,000 participants
Where: 1 siteUnited States
Study dates: Jan 2005to Aug 2006
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 day to 4 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

Harborview Injruy Prevention and Research Center
Seattle, Washington, 98104
Frederick P Rivara, MD, 206-744-9449, fpr@u.washington.edu
Frederick P Rivara, MD
Recruiting

Other trials in United States

About this study

Official title: Parents Helping Infants Study: Preventing Shaken Baby Syndrome and Child Abuse

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.

Read the detailed description

The specific goals of the program are:

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;
To change the behavior of parents to increase caregiving contact in response to crying but to 'walk away' if frustrated;
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;
To provide effective knowledge, skills and teaching materials to health care providers in direct contact with parents concerning crying, shaking and abuse;
To reduce the incidence of physical abuse and shaken baby syndrome under one year;
To have the Period of PURPLE Crying program adopted as a nationwide early intervention project.

Conditions: Child Abuse, Shaken Baby Syndrome
Being tested: Education about infant crying
Keywords: abuse
Medical subject headings: Shaken Baby Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Education about infant cryingBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

Knowledge and attitudes about crying, shaking and abuse
Caregiver behavior
Parenting sense of competence
Maternal depression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Aug 2006

First posted21 Mar 2005 (estimated)
Study startJan 2005
Study completionAug 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Child AbuseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Enrolment: 3,000 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00105963
Sponsor's protocol ID: HIPRCSBS-01
Status last verified: Mar 2005
First submitted: 18 Mar 2005
Last updated: 24 Jun 2005
Results posted: No

Publications

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.
PubMed 23650295

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Parents Helping Infants Study: Preventing Shaken Baby Syndrome and Child Abuse
ClinicalTrials.gov ID: NCT00105963
Acronym / sponsor ID: HIPRCSBS-01
Conditions: Child Abuse, Shaken Baby Syndrome
Keywords: abuse
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 3,000 participants
Lead sponsor: Harborview Injury Prevention and Research CenterUniversity, hospital or other
Study start: Jan 2005
Study completion: Aug 2006
First posted: 21 Mar 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific goals of the program are:

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;
To change the behavior of parents to increase caregiving contact in response to crying but to 'walk away' if frustrated;
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;
To provide effective knowledge, skills and teaching materials to health care providers in direct contact with parents concerning crying, shaking and abuse;
To reduce the incidence of physical abuse and shaken baby syndrome under one year;
To have the Period of PURPLE Crying program adopted as a nationwide early intervention project.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: Single blind

Who may qualify

Ages: 1 day to 4 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Education about infant crying	Behavioural	–

Primary outcome

Knowledge and attitudes about crying, shaking and abuse
Caregiver behavior
Parenting sense of competence
Maternal depression

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Derived from this study: PubMed 23650295Radesky 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.
Related InfoLink provided by the sponsor.

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QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harborview Injruy Prevention and Research Center

Seattle, United States

206-744-9449

fpr@u.washington.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Education about infant crying in people with Child Abuse and Shaken Baby Syndrome, run by Harborview Injury Prevention and Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge and attitudes about crying, shaking and abuse. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00105963, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.