Infant Colic, Postpartum Depression
Conditions
Keywords
Randomized Trial, Infant Colic, Abusive Head Trauma, Shaken Baby Syndrome
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).
Interventions
BEHAVIORALThe 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.
BEHAVIORALAAP Infant Colic counseling
Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 5 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean night-time crying | 2 weeks after enrollment. Appproximately 6-8 weeks of life. | Objectively recording night-time duration of excessive crying |
| Mean sleep duration | 2 weeks after enrollment. Appproximately 6-8 weeks of life. | objectively measuring infant sleep duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed