NCT03730194

A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this K01 study was to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize sleep health in adolescents 10-18 years of age with neurodevelopmental disorders (NDDs).

Detailed description

The investigators conducted a sequential, multiple assignment, randomized trial (SMART) pilot feasibility study to inform implementation of a future full-scale SMART design that will be used to construct adaptive biobehavioral sleep intervention strategies involving melatonin, a behavioral sleep intervention (The Bedtime Bank), and their combination for the management of sleep disturbance in adolescents with neurodevelopmental (NDDs). Participants completed 1 week of baseline data collection, and than were randomly assigned to either melatonin or The Bedtime Bank. Response (\>/= 18 minute average nightly increase in total sleep time \[TST\]) was measured at Week 4 and Week 8. Participants who responded (\>/= 18 minute average nightly increase in TST) at Week 4 remained on the assigned intervention. Participants who were non-responsive at Week 4 were re-randomized to a different sleep intervention or combined interventions.

Conditions

• Autism Spectrum Disorder
• Attention Deficit Hyperactivity Disorder
• Sleep Disturbance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin	Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
BEHAVIORAL	Bedtime Bank	The Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time.

Timeline

• Start date: 2019-05-31
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2018-11-05
• Last updated: 2023-12-22
• Results posted: 2023-04-04

Locations

1 site across 1 country: United States