Measuring and Reducing Excessive Infant Crying

Study Overview
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Brief Summary
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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
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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).

Official Title
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Measuring and Reducing Excessive Infant Crying: A Randomized Trial

Conditions
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Infant Colic, Postpartum Depression

Intervention / Treatment
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* Behavioral: The Happiest Baby on The Block
* Behavioral: AAP Infant Colic counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 5 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Happiest Baby on The Block<br>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<br>* Those receiving the intervention will be trained in the infant soothing techniques outlined in The Happiest Baby on the Block.<br>|
| Active Comparator: AAP Education<br>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<br>* Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Trial, Infant Colic, Abusive Head Trauma, Shaken Baby Syndrome