Keefe 2006.

Methods	Study design: randomised clinical trial of REST routine and video vs control (routine care) Location: USA Setting: interventions carried out in the patients' homes in Charleston (SC), Denver (CO)
Participants	Sample size: 137 infants Number of dropouts/withdrawals: 16 infants Mean age: 5.1 weeks Inclusion criteria: full term healthy aged between 2 and 6 weeks living within a 2‐hour radius of the metropolitan area had an average of 3 hours per day or more of unexplained crying over the past week or 2, as a minimum Exclusion criteria: none stated
Interventions	Intervention group (n = 64): REST programme, which is a home‐based intervention where a nurse provides support for the family. 4 home visits were conducted at weekly intervals and lasted 1 hour. The REST programme consisted of informing the parents to protect infants from exhaustion and overstimulation. To achieve this, parents aimed to synchronize the infant's sleep‐wake cycle and use various holds and positions repetitively. Educational material with videos and worksheets was also provided. Nurses aimed to provide support and reassurance to the parents. Control group (n = 57): received standard routine care, which was not described in the study Duration of intervention: 8 weeks
Outcomes	Primary outcome: crying time, measured using the Fussiness Rating Scale, which was completed by parents. Intervention group: mean crying time at baseline = 5.5 hours; mean crying time at 8‐week follow‐up = 1.29 hours (SD = 1.21) Control group: mean crying time at baseline = 5.9 hours; mean crying time at 8‐week follow‐up = 2.94 hours (SD = 3.17). P value < 0.02 Secondary outcome: parental or family quality of life: parental stress, measured using the Parental Stress Index Short Form (PSI‐SF). There was a reduction in total mean PSI‐SF scores for both the intervention and control groups. Intervention group: total mean PSI‐SF score at baseline = 87.0; total mean PSI‐SF score at 4 weeks = 76.6; 8 weeks = 71.0 Control group: total mean PSI‐SF score at: baseline = 92.5; total mean PSI‐SF score at 4 weeks = 78.8; 8 weeks = 77.2 The study also found reduced parental stress on the subscale for parental‒child dysfunctional interaction in the parent group compared to the control (P = 0.04).
Notes	Study start date: not stated Study end date: not stated Declared DOI: none stated Perceived DOI: study led by developer of REST technique Funding source: National Institute of Nursing Research Other comments: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: authors state only participants randomly assigned
Allocation concealment (selection bias)	Unclear risk	Comment: not mentioned
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: participants aware of interventions received
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: participants and personnel aware of interventions received. The data collection team were unaware of the group assignments or the intervention content.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: data from 16 participants lost to follow‐up not included in analysis
Selective reporting (reporting bias)	Low risk	Comment: all outcomes reported
Other bias	Unclear risk	Comment: study led by developer of REST technique