A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Condition: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Sleep Disturbance
MeSH terms: Hyperkinesis; Dyssomnias; Parasomnias; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Neurodevelopmental Disorders
Study type: Interventional

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.
    

Intervention name(s): Melatonin; Bedtime Bank
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime; 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.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The investigators utilized a sequential, multiple assignment, randomized trial (SMART) pilot feasibility study design 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.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Sleep Disturbance; Melatonin; ASD; ADHD