Abstract
Introduction: Introduction
Sleep disturbances are common in adolescents with neurodevelopmental disorders (NDDs). Inclusion of vulnerable populations such as adolescents with NDDs into sleep intervention efforts is essential as they are at high-risk for poor physical/mental health outcomes. The objective of this study is to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on treatment response, to optimize sleep health in adolescents with NDDs.
Methods: Methods
Recruitment began June 2019 using convenience sampling. The SMART pilot feasibility study includes 1-week of baseline sleep data, and two 4-week periods of a sleep intervention (9-week total study enrollment). Interventions include exogenous melatonin, The Bedtime Bank, and their combination. Exogenous melatonin (liquid, immediate release, 3mg) is administered 30 minutes before bedtime. The Bedtime Bank, a behavioral sleep intervention, is based upon contingency contracting that relies on a credit- or debt-based system to hold adolescents accountable for maintaining a consistent bedtime. At baseline participants completed demographics, PROMIS pediatric sleep questionnaires, the Cleveland Adolescent Sleepiness Questionnaire (CASQ), salivary & urinary endogenous melatonin measurement, and one week of actigraphy. Upon enrollment, participants were randomly assigned to either melatonin or The Bedtime Bank. Participants who respond (nightly increase in total sleep time (TST) ≥18 minutes) remain on the assigned intervention; if non-responsive participants are re-randomized to a different sleep intervention or combination.
Results: Results
At baseline, participants (n=29, aged 10–18 years) had an average TST of 7 hours 11 minutes. PROMIS Sleep Disturbance (M=64.3, SE=2.5), PROMIS Sleep-Related Impairment scores (M=58.9, SE=2.2), and CASQ scores (M=40.0, SD= 10.5) were higher than reported normative values. Salivary DLMO & urinary 6-sulfatoyxmelatonin analysis is ongoing. For participants who completed the full 9-week trial, nearly 30% (n=7/24) were responsive (increased baseline TST ≥18 minutes) to one of the 4-week interventions.
Conclusion: Conclusion
Baseline data of the enrolled participants demonstrates poor indicators of TST, sleep disturbance, and sleep related impairment. Preliminary results of this SMART indicate some adolescents are responsive to sleep interventions aimed to improve their TST.
Support (if any)
Support: This clinical trial is funded by the National Institute of Nursing Research, National Institutes of Health (1K01NR017465-01A1).
The Constitution as Source and Model: The Ethical Construction of New Repertoires Through Contingency Contracting