Symposium
Chair: Ian St.James-Roberts
Discussant: Dieter Wolke
COSI ( Crying or Sleeping Infants) is a recently completed randomised control trial of the use within the first three months of a behavioural programme designed to prevent long-tem infant crying and sleeping problems. The behavioural programme was compared to an educational intervention and to routine services. The behavioural programme asked parents to take three main steps: (i) to introduce a regular 'focal feed' between 10pm and midnight; (ii) to settle baby in the cot rather than while carried and maximise day:night differences in the environment; (iii) to 'stretch' the intervals between night-time feeds once infants were growing satisfactorily beyond three weeks of age. In an exploratory trial of this programme all 13 infants 'slept through the night' ( defined as not waking between midnight and 5am on at least 2 of 3 nights) by 8 weeks of age.The educational intervention provided parents with an information booklet based on best practice, together with a telephone helpline. Because the behavioural programme is prescriptive, the educational intervention was included to show whether the same results could be achieved by providing information and guidance.The control group families received the routine services, as did the other groups.205 infants were assigned at random to the behavioural programme, 202 to the educational intervention, and 203 to the control group. Behaviour diaries, kept prospectively at 1,3,6,9 and 12 weeks were used to confirm implementation and measure infant sleep and crying. Infant health, use of medications and weight gain were monitored. Questionnaires were used to measure the impact of sleep and crying problems on parents, mothers' satisfaction with their approach to care, and maternal wellbeing. Follow-up measures were obtained at 9 months of age.This presentation will report two main findings. First, we will examine which elements of the interventions parents implemented. This is particularly important, given the young age of the babies, reluctance of some parents to use behavioural methods in previous studies, and failure to confirm implementation in earlier research. We found no evidence that the educational intervention changed parental behaviour, whereas some elements of the behavioural programme, but not others, were implemented. Second, we will report the effects of the interventions on infant crying and sleeping. The behavioural programme led to a 10% increase in the number of infants who slept through the night by 12 weeks of age, with a marked effect on infants who were 'at risk' of long-term sleep problems. The interventions' impact on parents, parents' evaluations, and the 9 month measures will be summarised. The cost-effectiveness of the behavioural intervention will be reported separately in this symposium.
Details of individual items:
paper
Background and Purpose: Infant irritability or colic is the most common pediatric problem in the first year of life. Investigators and care providers are becoming increasingly concerned regarding the potential for abuse and neglect in families with these infants who cry for hours on a daily basis and are very difficult to console. Although several studies have been conducted over the last several decades, effective management strategies and appropriate information for parents regarding the etiology of this mysterious malady is still very limited. The purpose of this research study is to test a home-based, nursing intervention for these infants and their families that is based on a new conceptual understanding of the origins of infant irritability. The intervention that has evolved over the past ten years is referred to as the REST regimen. It is based on efforts to regulate and reduce the infants level of arousal by environmental and behavioral restructuring. Parents are provided support, reassurance, information and specific techniques to utilize with their infants.Research Hypotheses: The following two parental and two infant research hypotheses will be systematically evaluated in this clinical trial: (a) parents who receive the REST regimen will report less parental stress and exhibit more synchrony than parents who do not receive the REST regimen; (b) infants who receive the REST Regimen will demonstrate more state stability and less irritability than infants who receive routine care.Methods: Families with irritable infants between 2 to 6 weeks of age, that met the selection criteria were recruited and randomly assigned to receive either the REST regimen or routine well child care for a 4-week period. The intervention program referred to as The REST Regimen for Infant Irritability, has two major components: one focused on the infant - Regulation, Entrainment, Structure and Touch; and the other focused on the parent - Reassurance, Empathy, Support, and Time-Out. A team of advanced practice nurses delivers the program in the home and incorporates the use of infant behavioral 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 overstimulation.Results and Outcomes: A separate, trained evaluation team takes measurements at baseline and at prespecified intervals during the 4 weeks following the intervention program. Preliminary findings from the first two years of this trial describe the impact of the program on parental stress, parent-infant interaction, infant sleep patterns and infant crying. Data from the following four outcome measures: (a) Parenting Stress Index, (b) Nursing Child Assessment Feeding Scale, (c) infant state monitoring system, and (d) Fussiness Rating Scale will be summarized and presented. Funding: This four-year study is being funded by an R01 research award from the National Institute for Nursing Research of NIH.
paper
COSI ( Crying or Sleeping Infants) is a recently completed randomised control trial of the use within the first three months of a behavioural programme designed to prevent long-tem infant crying and sleeping problems. The behavioural programme was compared to an educational intervention and to routine services. The behavioural programme asked parents to take three main steps: (i) to introduce a regular 'focal feed' between 10pm and midnight; (ii) to settle baby in the cot rather than while carried and maximise day:night differences in the environment; (iii) to 'stretch' the intervals between night-time feeds once infants were growing satisfactorily beyond three weeks of age. In an exploratory trial of this programme all 13 infants 'slept through the night' ( defined as not waking between midnight and 5am on at least 2 of 3 nights) by 8 weeks of age.The educational intervention provided parents with an information booklet based on best practice, together with a telephone helpline. Because the behavioural programme is prescriptive, the educational intervention was included to show whether the same results could be achieved by providing information and guidance.The control group families received the routine services, as did the other groups.205 infants were assigned at random to the behavioural programme, 202 to the educational intervention, and 203 to the control group. Behaviour diaries, kept prospectively at 1,3,6,9 and 12 weeks were used to confirm implementation and measure infant sleep and crying. Infant health, use of medications and weight gain were monitored. Questionnaires were used to measure the impact of sleep and crying problems on parents, mothers' satisfaction with their approach to care, and maternal wellbeing. Follow-up measures were obtained at 9 months of age.This presentation will report two main findings. First, we will examine which elements of the interventions parents implemented. This is particularly important, given the young age of the babies, reluctance of some parents to use behavioural methods in previous studies, and failure to confirm implementation in earlier research. We found no evidence that the educational intervention changed parental behaviour, whereas some elements of the behavioural programme, but not others, were implemented. Second, we will report the effects of the interventions on infant crying and sleeping. The behavioural programme led to a 10% increase in the number of infants who slept through the night by 12 weeks of age, with a marked effect on infants who were 'at risk' of long-term sleep problems. The interventions' impact on parents, parents' evaluations, and the 9 month measures will be summarised. The cost-effectiveness of the behavioural intervention will be reported separately in this symposium.
paper
Objectives: The objectives of this paper were to estimate the cost of infant crying and sleeping problems in the first 12 weeks of life and to assess the cost-effectiveness of behavioural and educational interventions aimed at reducing infant crying and sleeping problems relative to usual services. The perspective taken was that of the UK National Health Service (NHS).Design: The analysis was conducted using data from the Crying Or Sleeping Infants (COSI) Study, a three-armed prospective randomised controlled trial that randomly allocated 610 mothers to a behavioural intervention (n3D205), an educational intervention (n3D202) or existing services (control, n3D203). Setting: West Berkshire, UK, between March 1997 and February 1998.Main outcome measures: Effectiveness was measured in terms of interruption-free nights gained from the behavioural and educational interventions relative to the control, where an interruption-free night was defined as a night in which the baby slept for five hours or more between the hours of 10pm and 6am. Cost components included the cost of each intervention and the cost of contacts with health care professionals pertaining to infant crying and sleeping. In order to calculate the annual total cost to the NHS of infant crying and sleeping problems in the first 12 weeks we multiplied the mean cost per baby of NHS contacts for infant crying and sleeping problems in the control group by the number of live births in that year in the UK. Cost-effectiveness was measured in terms of the incremental cost per interruption-free night gained for behavioural and educational interventions relative to control.Results: The mean interruption-free nights per baby across the whole 12 week period were 40.22 (SD3D20.25) for the behavioural intervention group, 39.03 (22.06) for the educational intervention group, and 37.02 (21.83) for the control group. Combining intervention costs and the cost of NHS contacts the mean cost per baby was A392.45 (SD3D116.92) for the behavioural intervention group, A398.96 (127.88) for the educational intervention group, and A390.64 (123.30) for the control group. The annual total cost to the NHS of infant crying and sleeping problems in the first 12 weeks was A365,000,000. Incremental costs per interruption-free night gained for the behavioural intervention relative to control were A30.56. For the educational intervention relative to control they were A34.13. Results were subjected to univariate and statistical sensitivity analysis.Conclusions: The annual total cost to the NHS of infant crying and sleeping problems is substantial. In the cost-effectiveness analysis, both the behavioural and educational interventions incurred a small additional cost for a small additional benefit. It is up to health care decision-makers to judge the attractiveness of these interventions and decide whether the extra costs are worth the extra benefits.