Measuring and Reducing Excessive Infant Crying
UTHealth THB
2 other identifiers
interventional
28
1 country
1
Brief Summary
Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp. The investigators will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2010
CompletedFirst Posted
Study publicly available on registry
October 8, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedDecember 8, 2015
December 1, 2015
4.7 years
October 6, 2010
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean night-time crying
Objectively recording night-time duration of excessive crying
2 weeks after enrollment. Appproximately 6-8 weeks of life.
Mean sleep duration
objectively measuring infant sleep duration
2 weeks after enrollment. Appproximately 6-8 weeks of life.
Secondary Outcomes (2)
Maternal Depression, Anxiety and Somatization
At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Salivary Biomarkers
At Study Entry and at 2 weeks after enrollment
Study Arms (2)
The Happiest Baby on The Block
EXPERIMENTALThose receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
AAP Education
ACTIVE COMPARATORThose receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).
Interventions
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
Eligibility Criteria
You may qualify if:
- term, singleton neonates
- otherwise healthy
- parent must have at least a 6th grade understanding of English or Spanish
- infant must have colic (greater than 3 hours of crying per day)
- OR the infant's crying causes excessive stress on the either parent
You may not qualify if:
- cannot have a condition which would reasonably impact alertness or behavior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - Pediatrics
Study Record Dates
First Submitted
October 6, 2010
First Posted
October 8, 2010
Study Start
January 1, 2011
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
December 8, 2015
Record last verified: 2015-12