Does melatonin improve sleep and functioning in children with Fetal Alcohol Spectrum Disorder? A comparison with placebo.

Not Applicable

• Conditions: Chronic Insomnia Disorder; Fetal Alcohol Spectrum Disorder; Delayed Sleep-Wake Phase Disorder; Mental Health - Other mental health disorders; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12619001360101
• Lead Sponsor: Griffith University

Brief Summary

Data being processed

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-03
• Study Completion: 2022-09-05
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Children aged between 5- and 12-years with confirmed prenatal alcohol exposure and who have been assessed using the Australian Guidelines for the diagnosis of FASD to have either FASD with 3 Sentinel Facial Features (SFF); FASD with < 3 SFF or At Risk” of FASD (Bower & Elliott, 2016), and with reported sleep problems (see Inclusion Criteria).
Sleep Problem Inclusion Criteria
Children will be included in the study if their parents/caregivers report that they have problems with sleep initiation, whereby sleep onset latency is equal to or greater than 30 minutes, three nights or more a week, for equal to or more than three months.

Exclusion Criteria

1) Are not currently receiving sedative medications,
2) Who have changed place of residence or primary carers in the last three months (as this instability may be contributing to sleep problems independent from FASD).
3) Have been diagnosed with Type 1 diabetes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep behaviour measured using a sleep diary and actigraphy[ Daily for 10 weeks]