Salisbury 2012.

Methods	Study design: randomised controlled trial of a family‐based intervention for infantile colic vs control (standard paediatric care) Location: USA Setting: intervention applied at clinic appointment
Participants	Sample size: 71 infants Number of dropouts/withdrawals: 1 infant Mean age: intervention group = 38.88 weeks (SD = 1.51), control group = 39.16 (SD = 1.32) Inclusion criteria: Infant: healthy singletons met Wessel's criteria for colic born at 37 weeks or later 4 to 8 weeks of age at enrolment not received greater than 4 days of nursery care after birth no congenital anomalies not been exposed to recreational drugs in utero did not have fetal alcohol syndrome Parent: able to speak English Mother: over 17 years of age without a history of psychiatric hospitalisation not involved with child protective services Exclusion criteria: not explicitly stated
Interventions	Intervention group (n = 30): psycho‐social family treatment, which consisted of 2 clinicians (behavioural paediatrician and mental health clinician) assessing together the causes of and responses to the infant's crying. The mental health clinician focused on reducing stress and self‐criticism. They provided information on normative sleeping, feeding and crying patterns. Methods to manage their stress and the distress of the infant were also provided. This culminated in an individualised family treatment plan provided as written recommendations. Control group (n = 31): standard paediatric care, which involved a brief office visit. Did not provide written recommendations or mental health management Duration of interventions: 6 weeks
Outcomes	Primary outcomes Crying time, recorded by parental diaries Intervention group: mean crying time at baseline = 4.89 hours (95% CI 4.13 to 5.65); mean crying time at 6 weeks = 3.10 hours. This equates to a 64% reduction in crying time (95% CI 60 to 69). Control group: mean crying time at baseline = 3.64 hours (95% CI 3.11 to 4.18); mean crying time at 6 weeks = 0.97 hours. This equates to a 27% reduction in crying time (95% CI 24 to 30). Secondary outcomes Parental or family quality of life: parental stress, measured using Parental Stress Index (PSI) at baseline and at 10 weeks. The study reported no group differences between parent training and control group. No values were provided. Infant sleeping, measured with diaries at 2 weeks. The study authors state that infants in the intervention group were sleeping more than the infants in the control group (P = 0.032). The study shows the mean hours per day on a graph at baseline, 2 weeks, 6 weeks and 10 weeks. However, it is not possible to elicit the values from the graph. Depression, measured using Becks Depression Inventory (BDI) at baseline and 10 weeks. Intervention group: mean BDI score at baseline = 14.48 (SD = 1.31); at 10 weeks, 25 mothers had a minimum 3‐point reduction. Control group: mean BDI score at baseline = 9.80 (SD = 0.29); at 10 weeks, 12 mothers had a minimum 3‐point reduction. Study authors did not state mean BDI scores and SD at post‐intervention. When adjusted for baseline scores, we deemed the difference to be not statistically significant (value not stated in paper).
Notes	Study start date: not stated Study end date: not stated Declared DOI: none stated Perceived DOI: none perceived Funding source: supported by Gerber foundation Other comments: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: parents selected their group assignment from a container in the presence of a research assistant
Allocation concealment (selection bias)	Low risk	Comment: parents selected their group assignment from a container
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: participant aware of intervention received
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: researcher aware of personnel in study arms
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: 1 infant dropped out and was not included in analysis
Selective reporting (reporting bias)	Low risk	Comment: all outcomes reported
Other bias	Unclear risk	Comment: supported by the Gerber Foundation