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

ClinicalTrials.gov · COMPLETED, 2021

40 participants

Abstract

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).

Conditions: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance.

Primary outcome: Actigraphy (Total Sleep Time); AARP- Abbreviated Acceptability Rating Profile.

Enrollment: 40 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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