A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- "Attention Deficit Hyperactivity Disorder"
- Autism Spectrum Disorder
- Sleep Disturbance
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: First, participants are randomly assigned to either melatonin or The Bedtime Bank. Response (>/= 18 minute nightly increase in total sleep time [TST]) will be measured at week 4 and 8. Participants who respond remain on the assigned treatment. Participants who are non-responsive are re-randomized to a different treatment option.Masking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 10 years and 18 years
- Gender
- Both males and females
Description
The investigators propose to conduct 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 ...
The investigators propose to conduct 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 NDDs. SMARTs allow for a 3-arm trial offering a significant advantage in comparing interventions and combinations of interventions within a single study design. First, participants are randomly assigned to either melatonin or The Bedtime Bank. Response (>/= 18 minute nightly increase in total sleep time [TST]) will be measured at Week 4 and 8. Participants who respond remain on the assigned treatment. Participants who are non-responsive are re-randomized to a different treatment option. To the knowledge of the investigators, a clinically meaningful increase in TST has not been reported in children. However, a nightly increase of 18 minutes in TST has been reported to improve school-performance. After a careful review of the literature, investigators chose to aim for a nightly increase of 18 minutes as a meaningful increase in TST.
Tracking Information
- NCT #
- NCT03730194
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Principal Investigator: Alyson E Hanish, PhD, MSN, RN University of Nebraska
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