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ISRCTN 48752250, registered Nov 2004
This trial aimed to find out whether a short Maternal and Child Health program could improve babies' sleep and mothers' wellbeing. The project began in 2003 when infants were 4 months old. Parents filled out the last questionnaire when children turned 2 in 2005. The children were re-enrolled into the Kids Sleep Study in 2009 when they were 6 years old.
695 babies and their mothers from six Melbourne local government areas took part. At 7 months of age, 328 mothers (47%) said their baby had a sleep problem. Of these mothers, two-thirds reported clinical levels of depression symptoms. Mothers who reported an infant sleep problem were randomly allocated to 2 groups. The "intervention" group was offered a brief program with their Maternal and Child Health nurse where they learned ways to manage their infants' sleep. Intervention nurses were trained to deliver the program. Other families were allocated to the "usual care" group. They didn't have extra visits with their nurse but could attend their routine checkups as usual.
The program was successful in reducing children's sleep problems up to 1 year of age and maternal depression up to 2 years. Based on the findings, the Department of Education and Early Childhood Development has since trained of all Victorian Maternal and Child Health Nurses in the program. The study findings have also been used in the 'Baby Sleep' pages of the Raising Children Website (http://raisingchildren.net.au) which provides information for parents about children from 0-8 years.
The Infant Sleep Study follows a highly successful efficacy study (publications included below). In 2010, the Infant Sleep Study won a Victorian Government Early Years Award.
Randomised controlled trial
Assoc Prof Harriet Hiscock firstname.lastname@example.org
Dr Jordana Bayer email@example.com
Prof Melissa Wake firstname.lastname@example.org
Hiscock H, Bayer J, Hampton A, Ukoumunne O, Wake M. Long-term mother and child mental health effects of a population-based infant sleep intervention: Cluster randomized controlled trial. Pediatrics 2008;122:e621-e627
Hiscock H, Bayer J, Hampton A, Ukoumunne O, Wake M. Improving infant sleep and maternal mental health: cluster randomised trial.Archives of Disease in Childhood 2007;92:952-958
Bayer J, Hiscock H, Hampton A, Wake M. Sleep problems in young infants and maternal mental and physical health. Journal of Paediatrics and Child Health 2007;43:66-73
Lam P, Hiscock H, Wake M. Outcome of infant sleep problems: a longitudinal study of sleep, behavior and maternal well-being. Pediatrics 2003;111:e203-e207
Hiscock H, Wake M. Randomised controlled trial of a behavioural infant sleep intervention to improve infant sleep and maternal mood. BMJ 2002;324:1062-1067
Hiscock H, Wake M. Infant Sleep Problems and Postnatal Depression: A Community Based Study. Pediatrics 2001;107:1317-1322
Sleep through the ages. The Australasian Sleep Association Annual Meeting, 2009, Melbourne, Australia.
Behavioural sleep disorders. Expert Session at the Royal Australasian College of Physicians Annual Scientific Meeting, 2009, Sydney, Australia.
Long-term outcomes of an infant sleep intervention. Tweddle Parenting Centre, Annual Meeting, 2008, Melbourne, Australia.
Long-term sleep, behavior, and maternal mental health impacts of a population-based infant sleep intervention: Cluster randomised trial. Pediatric Academic Societies Meeting, 2007, Toronto, Canada.
Effect of a brief community-delivered intervention on infant sleep problems and maternal health: a cluster randomised trial. Rue Wright Memorial Award finalist. Royal Australian College of Physicians Congress, 2006, Cairns, Australia.
Brief parenting intervention reduces infant sleep problems and improves maternal mental health: a cluster controlled trial. NIFTeY Conference, Prevention: invest now or pay later, 2006, Sydney, Australia.
Infant sleep and maternal wellbeing - effects and cost-effectiveness of a brief, nurse-led intervention. Department of Human Services - Annual Maternal and Child Health Nurse Conference, 2006.
The impact of an infant sleep intervention on early mental health. Early Childhood Evidence into Practice Conference: Queen Elizabeth Centre, 2006.
The Infant Sleep Study was the first large study to show that a brief infant sleep program can improve infant sleep and parent wellbeing into toddlerhood. Parents were very positive about the program. Despite this, experts still wonder about the long term benefits of simple infant sleep strategies, and even whether there may be adverse effects. New research has also suggested possible links between early sleep patterns and children's weight.
In 2009-10, the Kids Sleep Study followed-up these children when they were 6 years old. It aimed to answer these questions: does the original sleep program have long-term effects on:
Families took part in a home visit and parent-questionnaire. We collected a wide range of information. Children and parents reported on sleep and physical and mental health; we measured children's height, weight and activity levels; and collected biological makers of children's stress where possible.
At 6 years, we found that there were no lasting effects of the infant sleep program on children's emotional and behavioural well-being and stress, parent's well-being, or children's weight, height and general health.
Longitudinal follow up of a randomised controlled trial
Start: 2009 Finish: 2011
Centre for Community Child Health
Effects of an infant sleep intervention at child age 6 years: Randomised controlled trial. Price A, Hiscock H, Ukoumunne O, Wake M. Invited presentation for 'Problematic sleep in infancy: interventions, outcomes and controversies' Symposium. Sleep Down Under, Australasian Sleep Association Annual Conference, Sydney, Australia 27-29 October 2011.
Ongoing early child sleep problems predict poorer child emotional and global health at school-entry. Price A, Ukoumunne O, Wake M, Hiscock H. Winner of the Emerging Researchers Student Award Round. Royal Children's Hospital Campus Research Week, Melbourne, Australia 29 June-1 July 2011.
Does improving infant sleep prevent childhood overweight/obesity? Cluster randomized trial. [Poster presentation] Clifford S, Wake M, Price A, Ukoumunne OC, Hiscock H. ISBNPA (International Society for Behavioral Nutrition and Physical Activity) Annual Meeting, Melbourne, Australia 15-18 June 2011.
Outcomes Of "Controlled Comforting" At Child Age 6 Years: Randomised Controlled Trial. Price A, Hiscock H, Ukoumunne O, Wake M. IPSA (International Pediatric Sleep Association) Annual Conference, Rome, Italy 3-5 December 2010.
6-Year-Old Obesity Outcomes Of An Intervention That Improved Infant Sleep: Randomised Population-Based Trial [Poster presentation] Wake M, Price A, Clifford S, Ukoumunne O, Hiscock H. IPSA (International Pediatric Sleep Association) Annual Conference, Rome, Italy 3-5 December 2010.
Association Of Infant And Concurrent Sleep Problems With Child And Parent Wellbeing At School-Entry: Follow Up Of A Randomised Trial [Poster presentation] Price A, Hiscock H, Ukoumunne O, Wake M. IPSA (International Pediatric Sleep Association) Annual Conference, Rome, Italy 3-5 December 2010.
6 Year Outcomes Of An Infant Behavioural Sleep Intervention: Randomised Controlled Trial. Price A, Hiscock H, Ukoumunne O, Wake M. Accepted for the Emerging Researchers Student Award Round. Royal Children's Hospital Campus Research Week, Melbourne, Australia 4-8 October 2010.
6 Year Outcomes Of An Infant Behavioural Sleep Intervention: Randomised Controlled Trial. [Poster presentation.] Public Health Association of Australia Annual Conference 2010, Adelaide, Australia.
6 Glycosylated Haemoglobin: A Biomarker Of Child Mental Health And Quality Of Life? [Poster presentation.] Public Health Association of Australia Annual Conference 2010, Adelaide, Australia.
Impact Of "Controlled-Crying" On Child And Parent Mental Health To 6 Years: Randomized Controlled Trial. [Poster presentation.] Pediatric Academic Societies, 2010, Vancouver, Canada.
6-Year-Old Obesity Outcomes Of An Intervention That Improved Infant Sleep: Randomised Population-Based Trial. [Poster presentation.] Pediatric Academic Societies, 2010, Vancouver, Canada.
Impact Of "Controlled-Crying" On Child And Parent Mental Health To 6 Years: Randomised Controlled Trial. World Congress of International Medicine and the Royal Australian College of Physicians Congress 2010, Melbourne, Australia Pediatric Research Society of Australia and New Zealand (PRSANZ) Student Award Finalist.
Price A, Maayan T, Wake M, Hiscock H. Is glycosylated haemoglobin associated with psychosocial stress in non-diabetic 6-year-olds? Journal of Paediatrics and Child Health Provisionally accepted April 2 2013.
Price A, Wake M, Ukoumunne O, Hiscock H. Five-Year Follow-up of Harms and Benefits of Behavioral Infant Sleep Intervention: Randomized Trial. Pediatrics, originally published online 10 September 2012 doi: 10.1542/peds.2008-1536.
Independent commentary: Richdale, A. L. Behavioural infant sleep intervention does not have long-lasting effects on children's emotions or behaviour, or maternal outcomes. Evidence Based Mental Health 2013; Epub ahead of print 24 January 2013 doi: 10.1136/eb-2012-101123.
Price A, Hiscock H, Gradisar M. Let’s help parents help themselves: A Letter to the Editor supporting the safety of behavioural sleep techniques. Early Human Development 2012; originally published online 9 August 2012 doi:10.1016/j.earlhumdev.2012.07.018.
Price A, Wake M, Ukoumunne O, Hiscock H. Outcomes at 6 years of age for children with infant sleep problems: Longitudinal community-based study. Sleep Medicine 2012; 13: 991-998; originally published online 1 Jul 2012 doi:10.1016/j.sleep.2012.04.014.
Wake M, Price A, Clifford S, Ukoumunne OC, Hiscock H. Does an intervention that improves infant sleep also improve overweight at age 6? Follow-up of a randomised trial. Archives of Disease in Childhood 2011;96(6):526-532; originally published online 14 Mar 2011 doi:10.1136/adc.2010.196832.
Wake M, Price A, Hiscock H. Commentary: Does an intervention that improves infant sleep also improve overweight at age 6? Follow-up of a randomised trial. In: Lee-Chiong T, editor. Best of sleep medicine 2012. Denver, Colorado: CreateSpace. p. 186-88.