Measuring and Reducing Excessive Infant Crying (UTHealth THB)

The University of Texas System (UT)

Status: Completed

Conditions: Postpartum Depression; Infant Colic

Treatments: Behavioral: The Happiest Baby on The Block; Behavioral: AAP Infant Colic counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01217658

K23HD065872 (U.S. NIH Grant/Contract)

HSC-MS-10-0392

Details and patient eligibility

About

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.

Full 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).

Enrollment: 28 patients

Sex: All

Ages: 3 to 5 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

The Happiest Baby on The Block

Experimental group

Description:

Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".

Treatment:

Behavioral: The Happiest Baby on The Block

AAP Education

Active Comparator group

Description:

Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).

Treatment:

Behavioral: AAP Infant Colic counseling