Measuring and Reducing Excessive Infant Crying
- Conditions
- Postpartum DepressionInfant Colic
- Interventions
- Behavioral: AAP Infant Colic counselingBehavioral: The Happiest Baby on The Block
- Registration Number
- NCT01217658
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
- cannot have a condition which would reasonably impact alertness or behavior
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AAP Education AAP Infant Colic counseling Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling). The Happiest Baby on The Block 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".
- Primary Outcome Measures
Name Time Method Mean sleep duration 2 weeks after enrollment. Appproximately 6-8 weeks of life. objectively measuring infant sleep duration
Mean night-time crying 2 weeks after enrollment. Appproximately 6-8 weeks of life. Objectively recording night-time duration of excessive crying
- Secondary Outcome Measures
Name Time Method Maternal Depression, Anxiety and Somatization At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life. Using the BSI-18 at study enrollment and conclusion.
Salivary Biomarkers At Study Entry and at 2 weeks after enrollment We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)
Trial Locations
- Locations (1)
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States