A randomised controlled trial of behavioural interventions for infant sleep disturbance.

Completed

• Conditions: Sleep disorder; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12612000813886
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Infants identified by their parents as possessing a sleep problem; sleep onset latency > 30 min; wake after sleep onset > 60 min; number of awakenings > 3.

Exclusion Criteria

Atypically developing infants (physical and mental); clinical levels of maternal post-natal depression.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep (including sleep onset latency and wake after sleep onset, both in minutes; and the number of nocturnal awakenings). Outcome assessed with parent-completed 7-day sleep diaries of their infant's sleep, as well as a activity monitor worn on the infant's ankle.[Pre-treatment, 1 week after beginning treatment, 1 month after, 3 months after and 12 months after.]

Secondary Outcome Measures

Name	Time	Method
Infant stress (salivary cortisol).[pre-treatment, 1 week-, 1 month-, 3 months- and 12 months after treatment.];Parental (self-reported) stress, as measured by the Stress subscale of the Depression Anxiety Stress Scale (Short Form).[pre-treatment, 1 week-, 1 month-, 3 months- and 12 months after treatment.]