Child Abuse Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00595010 -
Effectiveness of a Multi-Component Evidence-Based Parent Training Program in Reducing Child Maltreatment
|
Phase 1 | |
Completed |
NCT00494286 -
Abuse-Focused Cognitive Behavioral Therapy for Children Who Have Been Physically Abused
|
Phase 1 | |
Completed |
NCT03956628 -
Evaluation of Preventive (Stay Safe) Training Program of Child Abuse for Teachers and Children
|
N/A | |
Completed |
NCT04257331 -
Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China
|
N/A | |
Recruiting |
NCT03198429 -
Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence
|
N/A | |
Completed |
NCT03185728 -
iLook Out for Child Abuse: An Innovative Learning Module for Childcare Providers
|
N/A | |
Completed |
NCT02415933 -
Child Protective Outcomes Among Ultra-poor Families in Burkina Faso
|
N/A | |
Recruiting |
NCT06100679 -
Responsible Engaged and Loving (REAL) Fathers Intervention Evaluation
|
N/A | |
Completed |
NCT04160013 -
Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children
|
N/A | |
Active, not recruiting |
NCT05729945 -
Catholic Health Initiatives (CHI) St. Joseph's Children Home Visiting Longitudinal Study
|
N/A | |
Completed |
NCT03305458 -
Improving Quality of Care in Child Mental Health Service Settings
|
N/A | |
Completed |
NCT04700696 -
Enhancing Permanency in Children and Families
|
N/A | |
Active, not recruiting |
NCT05479734 -
Promoting Resilience and Lowering Risk in Early Childhood
|
N/A | |
Completed |
NCT04163549 -
Evaluating the Effectiveness of the Safe at Home Program
|
N/A | |
Recruiting |
NCT04290234 -
Childhood Trauma and Escape Decision Dynamics
|
||
Recruiting |
NCT04637581 -
Wraparound for High-risk Families With Substance Use Disorders: Examining Family, Child, and Parent Outcomes
|
N/A | |
Not yet recruiting |
NCT03745573 -
Preventing Violence Against Children in Schools Study
|
N/A | |
Active, not recruiting |
NCT04163367 -
A Randomized Controlled Study of Safer Kids: A Manualized Intervention to Prevent Child Abuse
|
N/A | |
Completed |
NCT03135119 -
Integrating Animal-Assisted Therapy Into Trauma-Focused Cognitive-Behavioral Therapy for Maltreated Youth
|
N/A | |
Completed |
NCT04117971 -
Knowledge, Attitude and Practice of Child Abuse Diagnosis and Reporting Among a Group of Egyptian Dentists
|