Measuring and Reducing Excessive Infant Crying (UTHealth THB)

Measuring and Reducing Excessive Infant Crying: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression; Infant Colic
• Intervention / Treatment: Behavioral: The Happiest Baby on The Block; Behavioral: AAP Infant Colic counseling

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).

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Depression, Anxiety and Somatization	Using the BSI-18 at study enrollment and conclusion.	At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Salivary Biomarkers	We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)	At Study Entry and at 2 weeks after enrollment

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)

Publications and helpful links

Helpful Links

• American Academy of Pediatrics Infant Colic Website

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 6, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (Estimate): October 8, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Randomized Trial; Infant Colic; Shaken Baby Syndrome; Abusive Head Trauma
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Infant, Newborn, Diseases; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; Colic
• Other Study ID Numbers: HSC-MS-10-0392; K23HD065872 (U.S. NIH Grant/Contract)