An interventional study of The Happiest Baby on The Block and AAP Infant Colic counseling in Infant Colic and Postpartum Depression, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 3 Weeks to 5 Weeks. Per ClinicalTrials.gov, last updated 2015-12-08.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
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).
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 28 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
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Exclusion Criteria:
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 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 intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".
Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
Mean night-time crying
Objectively recording night-time duration of excessive crying
Time frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Mean sleep duration
objectively measuring infant sleep duration
Time frame: 2 weeks after enrollment. Appproximately 6-8 weeks of life.
Maternal Depression, Anxiety and Somatization
Using the BSI-18 at study enrollment and conclusion.
Time frame: 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)
Time frame: At Study Entry and at 2 weeks after enrollment
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston