Objective: The long term goal of this program of research has been to develop and test a theoretically consistent intervention that will be effective in guiding nursing practice when working with families with irritable infants. Infant irritability or colic is the most common and concerning condition during the first year of the infant’s life. Lack of understanding and inadequate approaches to managing this constant, persistent crying have been associated with maternal depression and infant abuse including shaken baby syndrome.
Design: This federally funded (R01-NR04661) intervention study employed a randomized experimental design in a two-site clinical trial. The data collection sites were the Medical University of South Carolina in Charleston and the Childrens Hospital in Denver, Colorado. The following two hypothesis were tested: 1) infants receiving the REST Regimen intervention will demonstrate less irritability and more sleep regularity than infants receiving routine care, and 2) parents receiving the REST Regimen intervention will report less stress and exhibit more synchronous interactions with their infants than parents receiving routine care.
Population and Setting: 140 healthy full-term infants between the age of 2 to 6 weeks were recruited into the study. 47 families were from the Charleston, S.C. area and 93 families were from the Denver metropolitan area. Participants were predominately Caucasian middle, upper income families. Mean age of the infant at time of entry into the randomized clinical trial was 5 weeks. A third group (n=30) of infants too old at entry for random assignment to a treatment group (mean age=10 weeks), were entered into a post-test only comparison group. All data collection and intervention visits were conducted in the participant’s home at their convenience.
Methods: The conceptually based intervention program referred, to as the REST Regimen, has two components. One aspect is focused on the infant organized around the concepts of regulation, entrainment, structure and touch. The second component directed at the parents is based on the concepts of reassurance, empathy, support and time-out. A team of advanced practice nurses delivers the intervention program in the home and incorporates the use of infant behavior assessment, pattern recognition, videotapes parent support and other educational materials. The family and infant are placed on a daily schedule of routine activities to reduce arousal and prevent over stimulation. A separate trained evaluation team takes measurements at baseline and a prespecified intervals following the 4 week intervention program
Outcome Measures: The following four primary outcome measures were used to evaluate the effectiveness of the intervention program: 1) amount of infant crying or unexplained fussiness, using the Fussiness Rating Scale, 2) quality of maternal infant interaction using the NCAST Feeding Scale, 3) parental stress using the Parenting Stress Instrument and 4) sleep pattern stability using a noninvasive infant state monitoring system.
Findings: Initial infant crying levels in both treatment groups was reported to be over 5 hours per day of unexplained crying. Both groups showed a decrease in crying over the 8-week study period. Infants in the REST Regimen treatment group cried approximately one hour less per day as compared to the control or routine care group. The posttest only group reported crying levels that were significantly higher than both the treatment and routine care group. Parenting stress was high for all the parents in the study compared to normative data. Scores showed marked improvement with the support provided by the visiting nurse. Quality of maternal infant interaction did not vary significantly in the three groups under study, based on the NCAFS assessment. Infant sleep pattern evaluation revealed disorganized sleep wake cycles, increased levels of indeterminate sleep and periods of episodic breathing. Program evaluation indicated a profile of families for whom the intervention was most effective and feedback was obtained that will be used to strengthen and enhance the intervention.
Conclusions and Implications: Several conclusions and observations can be drawn from this study. Families in both treatment groups reported benefiting from a nurse visiting in their home to inquire about their infant and their well being. The participants represent a subset of families with irritable infants who were referred into this study after a diagnosis of colic. The infants enrolled in the study represented the most persistent and severe crying behaviors and the parents reflected the most persistent and resourceful response patterns. The benefits of the program must be weighed against the cost of this 4-week, home-based intervention. Options for individualizing the program for those most in need of intensive home visiting and other delivery modes are discussed.
Back to Neonatal Interventions
Back to The Advancing Nursing Practice Excellence: State of the Science