Measuring and Reducing Excessive Infant Crying (UTHealth THB)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Christopher Greeley, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01217658
First received: October 6, 2010
Last updated: December 4, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention
Infant Colic
Postpartum Depression
Behavioral: The Happiest Baby on The Block
Behavioral: AAP Infant Colic counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Measuring and Reducing Excessive Infant Crying: A Randomized Trial

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Mean night-time crying [ Time Frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life. ] [ Designated as safety issue: No ]
    Objectively recording night-time duration of excessive crying

  • Mean sleep duration [ Time Frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life. ] [ Designated as safety issue: No ]
    objectively measuring infant sleep duration


Secondary Outcome Measures:
  • Maternal Depression, Anxiety and Somatization [ Time Frame: At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life. ] [ Designated as safety issue: No ]
    Using the BSI-18 at study enrollment and conclusion.

  • Salivary Biomarkers [ Time Frame: At Study Entry and at 2 weeks after enrollment ] [ Designated as safety issue: No ]
    We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)


Enrollment: 28
Study Start Date: January 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The Happiest Baby on The Block
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
Behavioral: The Happiest Baby on The Block
Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
Active Comparator: AAP Education
Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).
Behavioral: AAP Infant Colic counseling
Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.

Detailed Description:

Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, & depression assessed in the home by a masked nurse at 8 wks.

Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant & maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).

  Eligibility

Ages Eligible for Study:   up to 5 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • cannot have a condition which would reasonably impact alertness or behavior
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217658

Locations
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Responsible Party: Christopher Greeley, Associate Professor - Pediatrics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01217658     History of Changes
Other Study ID Numbers: HSC-MS-10-0392  K23HD065872 
Study First Received: October 6, 2010
Last Updated: December 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Randomized Trial
Infant Colic
Abusive Head Trauma
Shaken Baby Syndrome

Additional relevant MeSH terms:
Depression, Postpartum
Colic
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 23, 2016