A SMART Design to Improve Sleep in Adolescents with Neurodevelopmental Disorders is a study that seeks to improve sleep in adolescents with neurodevelopmental disorders using a behavioral intervention, The Bedtime Bank, and supplemental melatonin.
Participants are eligible if they meet the following criteria:
- 10-18 years of age and consistently living with parental (or legal guardian) supervision
- Diagnostic report of confirmed NDD diagnosis (Autism Spectrum Disorder or Attention-Deficit/Hyperactivity Disorder)
- Sleeping ≤ 8 hours in bed per night on 3 or more nights per week in the past month
- Medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medications (unless provider directed) during study participation
Participation includes:
- Enrolling in a 9-week clinical trial
- Wearing an activity monitor on the wrist (like a watch) throughout the 9-week trial
- Completing a sleep diary (3 minutes every morning) and sleep questionnaires (5 minutes every 4 weeks)
- Participation in open discussion regarding the adolescent’s sleep (10 minutes every 4 weeks)
- Attending three (3) in person meetings
- Meetings will be scheduled at times and locations convenient to you
Interested participants will receive screening by phone. Participants who are enrolled in this study will be randomly selected to receive one of the two sleep interventions (behavioral intervention or supplemental melatonin). Participants will receive all study-related material.
Participants will be compensated for their time.
IRB#775-18-FB. A SMART Design to Improve Sleep in Adolescents with Neurodevelopmental Disorders is funded by a grant from the National Institutes of Health – 1K01NR017465-01A1.
Further study information is available at link