The Effect of an Infant Sleep Behavioural Intervention to Treat Infant Sleep Problems on Infant Sleep and Maternal Mental and Physical Health: A Clustered Controlled Trial
- Conditions
- Concurrent maternal psychological (depression symptoms) and physical wellbeing which may or may not be related to the infant's sleeping patterns.Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)Mental Health - DepressionSleep problems (e.g. frequent night waking) in babies aged 6 to 12 months.
- Registration Number
- ACTRN12607000036415
- Lead Sponsor
- DR Harriet Hiscock
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 270
Families recruited were attending community well-child clinics across 6 Melbourne local government areas when infants were 4 months postpartum in October/November 2003. Families were recruited from a broad sociodemographic sample. Infants whose parents reported a problem with their sleep at 7-8 months were then eligible to take part in the intervention trial.
Infants born before 32 weeks gestation, mothers with insufficient English to complete brief written questionnaires, and mothers who did not report an infant sleep problem at 7-8 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maternal report of an infant sleep problem when infants turned 10 and 12 months old [When infants are 10 and 12 months old (ie approximately 2 and 4 months post randomisation).]
- Secondary Outcome Measures
Name Time Method Maternal psychological and physical wellbeing, maternal sleep quantity and quality.[When infants turned 10 and 12 months old ];Economic evaluation (cost consequences).[When infants turned 10 and 12 months old ]