What is infantile colic?
Infantile colic is a condition where a seemingly healthy infant up to the age of four months has periods of inconsolable and unexplained crying. These periods of crying tend to last more than three or more hours per day, and occur three days per week for at least three weeks. This can cause parents to become exhausted and concerned whilst attempting to comfort their child.
What are parent training programmes?
Parent training programmes involve providing training, support and psychological interventions to parents, to help reduce their infant’s symptoms and parents' anxiety levels.
What did the researchers investigate?
This Cochrane Review aimed to assess the effectiveness and safety of parent training programmes for managing infantile colic, and to identify the educational content and attributes of such programmes.
This review found seven relevant, small, randomised controlled trials (a type of experiment in which participants are randomly allocated to two or more groups), with 1187 participants. All studies included infants younger than four months of age. The duration of the interventions varied, with the shortest being six days and the longest being three months. Four studies were conducted in the USA, one in Canada, one in the Netherlands and one in Iran. Four studies stated their funding sources, which included national research institutes, foundations and nutritional companies.
Five of the studies compared a parent training programme with a control (reassurance, no intervention or rocking the baby in their crib). One of these studies also compared training programmes to a third group who received a specialised baby seat. One study compared a parent training programme against a milk-exclusion diet. The last study compared a parent training programme to the same parent training programme plus swaddling. Details of the content of training was limited, but most interventions commonly focused on one or a combination of the following: soothing techniques for crying infants (six studies); general care advice including sleep (four studies); feeding advice (two studies); stress reduction and empathic counselling for parents (two studies); and positive play interaction advice (one study).
We found evidence to suggest that parent training programmes may reduce infants' crying time compared to control. However, the evidence for this comes from just three small studies (157 infants) that suffered from a range of weaknesses. We therefore considered the overall certainty of these findings to be low. We found evidence from one small study (20 infants) that crying time at completion was shorter for infants on a milk-exclusion/soy milk formula than for parent training. For the comparisons ʻParent training versus specialised baby seatʼ and ʻParent training plus swaddlingʼ we found no useable data on which to draw conclusions.
None of the included studies explicitly reported the occurrence of adverse effects of parent training.
Although our analyses suggest that crying times may be reduced amongst infants whose parents attend parent training programmes, the certainty of the evidence is low. Further, better-designed randomised controlled trials are needed to answer questions on the effectiveness and safety of parent training programmes for managing infantile colic.
There is limited evidence on the effectiveness and safety of parent training programmes for managing infantile colic. Despite a single meta-analysis showing that parent training may reduce crying times for infants, compared to control, the certainty of the evidence was low. Evidence for other comparisons was sparse. We were unable to identify comprehensively the educational content and attributes of the included programmes due to a lack of information in study reports. Further RCTs are needed: they should define interventions clearly to ensure replicability, address all appropriate outcome measures, and minimise risk of bias in order to assess definitively the role of parent training programmes in managing infantile colic.
Infantile colic has an effect on both infants and their parents, who become exhausted and concerned as they attempt to comfort their child. Common approaches have focused upon physical treatments to reduce symptoms, with inconclusive evidence as to their effectiveness. An alternative approach seeks to provide training, support and psychological interventions for parents. This approach is known as parent training programmes. Programmes can include soothing techniques, advice on feeding or normalisation material in any form. The teaching format can vary including face-to-face courses, online learning, printed materials, home visits and remote support and counselling. Here, we aim to collate the evidence on the effectiveness of these interventions and examine their effectiveness at reducing infantile colic symptoms and parental anxiety levels, and their safety.
1. To evaluate the effectiveness and safety of parent training programmes for managing colic in infants under four months of age.
2. To identify the educational content and attributes of such published programmes.
In June 2019 we searched CENTRAL, MEDLINE, Embase, 13 other databases and two trials registers. We also handsearched conference abstracts, inspected the references of included studies and contacted leaders in the field for more trials.
Randomised controlled trials (RCTs) and quasi-RCTs investigating the effectiveness of any form of parental training programmes, alone or in combination, versus another intervention(s) or control, on infantile colic.
Two authors independently selected studies for inclusion, extracted data, and assessed the risk of bias within the included studies. We used Review Manager 5 to analyse the data. We assessed the certainty of the evidence using GRADE methodology.
Our search found 6064 records from which we selected 20 for full-text review. From these, we identified seven studies with 1187 participants that met our inclusion criteria. All of the studies included infants under the age of four months suffering from infantile colic. Four studies were conducted in the USA, one in Canada, one in the Netherlands and one in Iran. Four studies stated their funding sources, which included national research institutes, foundations and nutritional companies. Five studies assessed parent training versus a control group that received reassurance or routine care; and of these, one study was three-armed and also examined the effectiveness of using a specialised baby seat. One study examined parent training programmes against a milk-exclusion diet and one study assessed a parent training programme versus the same parent training programme plus swaddling. The duration of the interventions varied, with the shortest being six days and the longest being three months.
Generally, most studies had low participant numbers and were at high risk of bias, prone to selection bias, performance bias, and the placebo effect.
We could not complete the planned qualitative analysis (objective 2) due to lack of data in study reports and no further information being supplied by authors on request. Instead, we completed a descriptive content analysis with the limited information available. The parent training interventions were found to focus on one or a combination of the following: soothing techniques for crying infants (six studies); general care advice, including sleep (four studies); feeding advice (two studies); stress reduction and empathic programme for parents (two studies); and positive play interaction advice (one study). One study taught 'kangaroo care', a specific form of skin-to-skin cuddling. The control groups consisted of reassurance (two studies), advice to rock the infant in the crib (one study), or no intervention (two studies).
Parent training versus control
We conducted a meta-analysis using data from three studies (157 infants) that assessed the primary outcome of 'crying time at completion of study period'. Parent training was more effective than control: mean difference (MD) −113.58 m/d, 95% confidence interval (CI) −144.19 m/d to −82.96 m/d; low-certainty evidence (downgraded due to imprecision and some concerns with risk of bias).
Parent training versus specialised baby seat
One study (38 participants) found no difference in mean crying time at completion between the parent training group and the specialised baby seat group, but did not report specific figures.
Parent training versus a milk-exclusion/soy milk formula
One study (20 participants) comparing parent training with a milk-exclusion/soy milk formula found crying time at completion of the study to be 2.03 hours versus 1.08 hours, respectively.
Parent training versus parent training plus swaddling
One study (398 participants) comparing parental training with the same intervention plus training on how to swaddle an infant did not report separate data for each group.
No adverse effects were reported, but these were not explicitly reported in any study.