a Pediatric Department, University Hospital of North Norway Trust, Tromsø, Norway
b Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway
c Institute for Educational Research, University of Oslo, Oslo, Norway
| ABSTRACT |
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OBJECTIVES. Our goal was to study the effects of an early-intervention program on parenting stress after a preterm birth until 1 year corrected age.
METHODS. A randomized, controlled trial was conducted including infants with a birth weight <2000 g treated at the University Hospital of North Norway Trust, which serves the 2 northern-most counties in Norway, to examine the effects of a modified version of the Mother-Infant Transaction Program on parenting stress measured by the Parenting Stress Index. A term control group was also recruited. The Parenting Stress Index was administered to the mothers at 6 and 12 months corrected age and to the fathers at 12 months corrected age. The intervention consisted of 8 sessions shortly before discharge and 4 home visits by specially trained nurses focusing on the infants unique characteristics, temperament, and developmental potential and the interaction between the infant and the parents.
RESULTS. Seventy-one infants were included in the preterm intervention group, and 69 were included in the preterm control group. The preterm groups were well balanced. Seventy-four infants were included in the term control group. Compared with the preterm controls, both the mothers and fathers in the preterm intervention group reported significant lower scores in child domain, parent domain, and total stress on all occasions except the mother-reported child domain at 12 months. These differences were not related to birth weight or gestational age. The level of stress among the preterm intervention group was comparable to their term peers. Both parents in the intervention group reported consistently lower scores within the distractibility/hyperactivity, reinforces parents, competence, and attachment subscales compared with the preterm control group. There were no differences in mean summary stress scores between the mothers and fathers in the 2 preterm groups at 12 months, but the intraclass correlation coefficient was higher in the intervention group.
CONCLUSIONS. This early-intervention program reduces parenting stress among both mothers and fathers of preterm infants to a level comparable to their term peers. We are now studying whether this will result in long-term beneficial effects.
Key Words: preterm infants parenting stress early intervention randomized controlled trial
Abbreviations: UNNUniversity Hospital North Norway Trust BWbirth weight GAgestational age MITPMother-Infant Transaction Program PSIParenting Stress Index ICCintraclass correlation coefficient CIconfidence interval ANCOVAanalysis of covariance VLBWvery low birth weight
Giving birth to a preterm infant is considered to be a stressful event for parents. Many studies have shown that mothers of these infants experience increased levels of stress in the neonatal period compared with mothers of term infants,14 and they are more likely to suffer from depression and anxiety at the time of hospital discharge.5,6 Recently, Carter et al7 found increased depressive symptoms also among fathers of preterm infants during the NICU stay. The long-term adaptation of the mothers to a normal life after a preterm birth is less studied, and the results are conflicting.810 There is even less information about the fathers adaptation.
Today there is increasing knowledge and concern about the long-term outcome in children born prematurely. Both cognitive delay and behavioral and emotional problems are reported in a large percentage of very preterm infants.11,12 Different early-intervention programs have had limited success in preventing these long-term sequelae and the behavioral problems in particular. Increased parenting stress during the first year of the infants life has been found to be an important risk factor for later behavioral problems in some studies,1317 but not all of them.18 It is assumed that increased parenting stress could interfere with the parent-child relationship during early childhood and consequently increase the risk for later behavioral problems. Reduced parenting stress might increase the parents sensitivity to different signals from their child and improve the parent-child interaction.
We therefore initiated a randomized, controlled trial of an early-intervention program that focuses on the interaction between the parents and their premature infant to examine whether the intervention could prevent later cognitive and behavioral problems in children born prematurely.
The main purpose of this first report is to examine if an early-intervention program could reduce parenting stress in both mothers and fathers during the first year after a premature birth.
| PATIENTS AND METHODS |
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The parents were informed about the study by the coordinating study nurse approximately 2 weeks before planned discharge and signed an informed consent form if they agreed to participate. The infants were randomly assigned into either the preterm intervention group or preterm control group. Both twins were always randomly assigned to the same group because of the character of the intervention. Randomization was arranged in random blocks of 4 and 6 using computer-generated random numbers and stratified by gestation (<28 and
28 weeks). The allocation was performed by using sealed opaque envelopes, identified by stratification group and consecutively numbered, which were opened after the completion of various questionnaires. The envelopes were prepared before the study started by the Office for Clinical Research at UNN and opened by the coordinating study nurse. A group of term controls with a gestational age (GA)
37 weeks and BW >2800 g, without congenital anomalies and with an uneventful pregnancy and birth, was also recruited from the hospitals well-infant nursery. Using the hospitals birth registry, the parents of the first term infant born after a preterm infant had been allocated to the preterm intervention group were asked to participate, and if they declined, the parents of the next born (and so forth) were approached.
Intervention
The intervention program was a modified version of the Mother-Infant Transaction Program (MITP),19 which was developed for and used in the Vermont Intervention Study.20 The modifications included an initial session in which the parents could vent experiences from the hospital stay and possibly their feelings of grief. Such feelings include feelings of grief for not having "a normal infant," guilt and blame about possible reasons for the preterm birth, anxiety about their infants survival, and concerns for the future normality of their infant.1 Second, we tried to adopt a more active participation from both the mother and the father in evaluating and handling the infants and their cues.
The MITP emphasizes the transactional nature of development21 and tries to enable the parents to appreciate their infants unique characteristics, temperament, and developmental potential. Furthermore, the intervention tries to sensitize the parents to their infants cues, especially those that signal stimulus overload, distress, and readiness for interaction, and teaches the parents to respond appropriately to those cues to facilitate mutually satisfying interactions. After the initial grief-handling session, the intervention was implemented by neonatal nurses through 1-hour daily sessions with the parents and infant on 7 consecutive days starting 1 week before planned discharge at a GA of at least 34 weeks. These daily sessions were followed-up by 4 home visits by the same intervention nurse 3, 14, 30, and 90 days after discharge. A detailed outline of the MITP and the content of the different interventional sessions has been given by Rauh et al19 and the Norwegian Manual (unpublished manuscript, 1997).
Eight experienced neonatal nurses working in the department were specially trained for the intervention. They kept a detailed logbook of every interventional session, and the logbooks were regularly reviewed and supervised by the coordinating nurse and a psychologist (J.A.R.) to maintain the consistency of the intervention.
The preterm control group followed the units standard protocol for discharge of preterm infants, which includes an examination and offer of training in infant massage from the units physical therapist, a clinical examination including visual and hearing screening, and a discharge consultation with one of the doctors.
The term control group went through a routine clinical examination on the third day of life. No other interventions were offered.
Instruments
The Parenting Stress Index22 (PSI) was used to measure stress in the parent-child relation. The PSI has been standardized with parents and children ranging in age from 1 month to 12 years in different cultures and is considered to be a reliable instrument across cultures. The self-reported questionnaire consists of 101 items that are scored on a 5-point Likert scale. The Norwegian version used was translated and back-translated by Abidin and J.A.R. The PSI consists of a child domain and a parent domain. The child domain score reflects parental stress associated with the childs individual characteristics as measured on 6 subscales: distractibility/hyperactivity, adaptability, reinforces parent, demandingness, mood, and acceptability. The parent domain reflects parental stress associated with the parental role and is measured on 7 subscales: competence, isolation, attachment, health, role restriction, depression, and spouse. Overall scores for the child and parent domains are obtained by summing the scores of their respective subscales, and a combination of the domain scores gives the total stress score. Higher scores indicate more stress. The life stress dimension of the PSI was also calculated. This dimension is a measure of negative life experience during the last 12 months. Missing values on different items were handled according to the PSI manual,22 so the numbers with valid summary scores, therefore, will vary slightly. The PSI was filled out by the mothers when the infant was at 6 months corrected age and by both parents at 12 months corrected age.
Perinatal variables were abstracted from the medical charts. GA was based on ultrasound examinations at 16 to 18 weeks of gestation. The Score for Neonatal Acute Physiology23 and Clinical Risk Index for Babies24 were calculated for the preterm infants as an indicator of severity of initial disease. Small for GA was defined as a BW >2 SD below the mean for GA. Norwegian BW data were used.25 Intraventricular hemorrhage was graded according to Papile et al,26 and periventricular leukomalacia was defined as the presence of echolucencies by cranial ultrasound. Social variables used in the analysis were obtained at discharge with a separate questionnaire.
All infants were examined clinically by an experienced neonatologist (L.B.D.) at 6 and 12 months corrected age for possible neurologic sequelae. The examiner was blinded to the infants group allocation.
Outcomes
Primary outcomes were the differences between the preterm intervention group and preterm control group in the PSI summary scores of child domain, parent domain, and total stress reported by the mothers at 6 and 12 months corrected age and by the fathers at 12 months corrected age.
Secondary outcomes were differences in the PSI subscales between the 2 preterm groups, differences in intervention effects related to BW, GA, and social factors, changes over time in group effects in stress scores reported by the mothers at 6 and 12 months corrected age, and differences between mothers and fathers.
Power Calculations
This study is part of a more comprehensive interventional study with long-term follow-up of the infants, and the study size was originally calculated on the basis of differences between the preterm groups in cognitive development at 2 years adjusted age. This power analysis indicated that 60 preterm infants needed to be included in the intervention and control groups, respectively. Allowing for loss in follow-up, the target group size was 70 infants, and a similar number of term controls were recruited. With group sizes of 70, there was 80% chance to detect a difference between the 2 preterm groups of .48 SD in the PSI scores with a level of significance of .05.
Statistics
Standard t tests were used for testing the a priori differences in continuous variables between the preterm groups. Multiple-regression analysis with appropriate interaction terms were used in subgroup analysis. Repeated-measures analysis of variance was used to test changes in group differences at 6 and 12 months corrected age. Paired t tests and intraclass correlation coefficients (ICCs)27 were used to test differences between stress scores in mothers and fathers at 12 months corrected age. Differences in continuous variables are given as mean difference with 95% confidence intervals (CIs) unless otherwise stated. Cohens d was used as a measure of effect size.28 Cohens d is the ratio between the mean difference and the pooled SDs for the sample. Analysis of covariance (ANCOVA) was used in a preplanned secondary analysis to adjust for possible confounding effects of socioeconomic status. All results are reported as intention to treat. All analyses were performed by using Stata 8.0.29 The study was approved by the Regional Committee for Medical Research Ethics and the Norwegian Data Inspectorate.
| RESULTS |
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Intervention
One infant allocated to the preterm intervention group did not receive the planned intervention. This infant is included in the intervention group in the analysis (intention to treat). All mothers participated in every intervention session, whereas 60 (94%) of 64 fathers participated in
1 session. The fathers participated in a median of 6 of 12 intervention sessions (home visits included) (interquartile range: 49 sessions).
Primary Outcome
Table 2 shows the child-domain, parent-domain, and total stress scores for the different groups of infants at 6 and 12 months corrected age for prematurity. The preterm intervention group had significantly lower scores in all scores at both 6 and 12 months compared with the preterm control group except child domain reported by the mothers at 12 months, where the difference was only borderline significant (P = .08). The effect sizes of the interventions were small to moderate, with Cohens d ranging from .30 to .50 (Table 2). There were no significant differences between the 2 preterm groups in the life stress dimension reported by the mothers at 6 and 12 months and fathers at 12 months.
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Subscales
The parents in the preterm intervention group had consistently lower scores than those in the preterm control group in all subscales in both the child and parent domains. However, the only subscales in which these differences reached statistical significance are shown in Table 3. The most consistent differences between the 2 preterm groups were found in the subscales of distractibility/hyperactivity, reinforces parents, competence, and attachment.
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Differences Between Mothers and Fathers
To test whether there were any differences in the reported stress between mothers and fathers at 12 months, we compared their reported mean stress scores by paired t tests and calculated the ICCs within each group (Table 4). There were no significant differences in mean scores between the genders in child or parent domain or total stress, although the differences in means tended to be somewhat lower in the preterm intervention group. In child domain, the ICC was substantially higher in the preterm intervention group than in the preterm control group and lowest in the term control group.
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= 0.33; P = .01). When this analysis was repeated on the various PSI subscales, we found a consistent pattern in which the fathers reported significantly higher mean scores in the subscales of reinforces parents and attachments within all 3 infant groups compared with the mothers at 12 months (Table 5). The ICCs were generally low, again with the highest values in the preterm intervention group and lowest in the term control group, although the differences were small. The mothers reported higher scores in the role-restriction subscale within all groups, whereas the mothers in both preterm groups reported higher scores in the spouse subscale (Table 5).
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The mothers and fathers education and income, number of siblings, and the mothers age were entered as independent variables in addition to group allocation (preterm control versus intervention). Total stress scores at the different time points were used as dependent variables. We first examined whether there were any significant interactions between the group variable and the other covariates, which would render the ANCOVA invalid. There were no such significant interactions.
These ANCOVAs resulted in adjusted group differences of 17.3 (95% CI: 5.4 to 29.2; P = .005) for the mother-reported total stress score at 6 months and 13.4 (95% CI: 1.1 to 25.8; P = .03) at 12 months. For the fathers, the adjusted group difference at 12 months was 12.2 (95% CI: 0.5 to 25.0; P = .06).
| DISCUSSION |
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One might argue that a preintervention measurement of parenting stress to demonstrate that there was no imbalance between the preterm groups at baseline would have strengthened our study. The PSI, however, is only validated in infants from 1 month of age. Despite this, we did in fact administer the PSI to the mothers before the intervention. Because of a vast number of unanswered items (up to two thirds in some items), it was impossible to use these results in the analysis. The strict randomization procedures undertaken in this study should result in comparable groups, and we found the preterm groups to be well balanced regarding GA, BW, initial disease severity, various neonatal complications, and different social factors. Furthermore, there were no differences between the groups in reported life stress on any occasions. Thus, there is substantial reason to attribute the observed reduction in parenting stress to the intervention program. The small, but significant difference in the length of the preterm mothers education is a result of chance. The importance of such an imbalance primarily depends on the correlation between the factor and outcome. We performed a preplanned ANCOVA as a secondary analysis to adjust for potential confounding effects of various social variables. The differences in total stress between the 2 preterm groups as reported by the mothers were only slightly changed by this adjustment. Among the fathers, the potential interventional effect was reduced from 14.8 to 12.2, which might indicate some confounding, although the change is small.
There was a significant negative correlation between total stress and the number of interventional sessions in which the fathers participated, which suggests a direct interventional effect. The effect among fathers could also, at least partly, be an indirect effect from the mother (ie, more confident and less stressed mothers could lead to reduced stress among their husbands).
The intervention effect was not related to differences in BW or GA, and there were no changes in the effect among mothers from 6 to 12 months.
The size of the interventional effect is somewhat difficult to interpret. A reduction in the total-stress score of 16.9 points as observed between preterm mothers at 6 months has no obvious meaning when compared with a similar reduction in, for example, intelligence quotients. We therefore used Cohens d as a measure of effect size. This is an extensively used measurement of effect size in behavioral research, and some researchers argue that it should be preferred to P values. A Cohens d of .5 is generally regarded as a moderate effect size, meaning that the intervention led to a .5 SD change in outcome. We found an effect size of .30 to .50, which compares favorably to other early preventive intervention studies in early childhood as found in a recent meta-analyses by Bakermans-Kranenburg et al.32
The effect of the intervention was also examined on the different PSI subscales. This must be considered as an exploratory analysis and the results interpreted with care because of the multiple comparisons that were performed. However, a quite distinct pattern emerged, indicating that the intervention had the greatest effects on the distractibility/hyperactivity, reinforces parents, competence, and attachment subscales, with some variation in both the fathers and mothers. We find this effect plausible in light of the character of the intervention. The interventional program (as described in "Patients and Methods") was focused on enabling the parents to interpret and act according to their infants cues, thereby strengthening the parent-infant relationship and making them feel more competent in handling their preterm infant.
Many studies have shown that mothers experience more stress than fathers both during the NICU stay and also later after discharge.10,3335 We found no mean differences between the fathers and mothers in any of the PSI summary scores 12 months after the premature birth. However, we found a markedly higher ICC in the child domain in the preterm intervention group compared with both control groups. It is possible that this may be a result of the intervention, which focused on teaching the parents to respond adequately to the infants cues. We speculate that this could result in more consistent judgements between the parents of stress related to the child also in later infanthood. Similarly, less involvement by the fathers in the infants newborn period and possibly later because of different social roles could explain the low ICCs in child domain found in the term control group.
Tommiska et al10 found a nonsignificant increase in total stress score measured by the Swedish Parenthood Stress Questionnaire (SPSQ) among mothers compared with fathers of extremely low BW infants 2 years after birth, the difference being largest in the incompetence and spouse-relationship subscales. However, the SPSQ measures stress mainly in dimensions included in the PSI parent domain and has no dimensions parallel to the PSI child domain, and the response rate from the fathers was very low. When analyzing the differences between mothers and fathers in the PSI subscales, we found a consistent pattern within both preterm groups but also in the term control group. The fathers scored higher in the child-related reinforces parents and attachment subscales, whereas the mothers scored higher in the parent-related role restriction and spouse subscales. This finding is consistent with the Tommiska et al findings, with increased maternal stress in the parent domain subscales. Our finding that these differences between mothers and fathers were similar across the different infant groups indicates that these differences are related to traditionally different roles of mothers and fathers in our societies and families, not to prematurity per se. This finding underlines the importance of including a term control group in studies such as this.
There has been some controversy in the literature about parenting stress after a preterm birth. Increased stress among the mothers during a stay in the NICU or during the first few months after discharge has been a common finding in various studies using different instruments, although the mothers in some studies seem to adapt rather quickly to their situation.34,36,37 Some cross-sectional studies have found a more sustained increase in parenting stress,33,38 whereas others have not.9,10,39 In one of the few longitudinal studies using the PSI to date, Singer et al8 found an increase in child domain scores in mothers of VLBW infants with bronchopulmonary dysplasia compared with mothers of term infants, but there was no difference in the parent domain. They found no differences between mothers of low-risk VLBW infants compared with their term peers. Our study was not designed to examine different risk strata of preterm infants, so a direct comparison is not possible, but a substantial part of our infants were low-risk preterm infants (Table 1). Our results when comparing the preterm and term control groups are in line with those studies finding a persistent increase in parenting stress at least during the first year after a preterm birth (Table 2). Our finding that the increased parenting stress is primarily due to an increase in the child domain is in accordance with other studies using the PSI.8,38
Reducing parenting stress may be important by itself, leading to better lives for families with a preterm child. However, because some studies have shown that parenting stress is a risk factor for later behavioral problems in both preterm1317 and other40 children, the reduction in parenting stress during the infants first year of life may potentially be an important factor in reducing long-term behavioral problems in these infants. To date, no studies have examined this possible effect of reduced parenting stress, but this will be an important aspect of the long-term follow-up of the infants included in our study.
| STRENGTHS AND WEAKNESSES |
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| CONCLUSIONS |
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| ACKNOWLEDGMENTS |
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We thank Bjørn Helge Handegård for statistical advice and the Office for Clinical Research at the University Hospital of North Norway Trust for help with the randomization procedures. We thank the neonatal nurses who implemented the intervention program and the coordinating nurse, Jorunn Tunby, in particular. Without their efforts, this study would not have been possible. We also thank the families and infants for participating.
| FOOTNOTES |
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Address correspondence to Per Ivar Kaaresen, MD, Pediatric Department, UNN, N-9038 Tromsø, Norway. E-mail: per.ivar.kaaresen{at}unn.no
The authors have indicated they have no financial relationships relevant to this article to disclose.
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