Measuring and Reducing Excessive Infant Crying
| Status: | Completed |
|---|---|
| Conditions: | Depression, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | September 2015 |
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.
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).
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).
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
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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