Clinical trial NCT03730194: A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Official title: A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Sleep Disturbance
Keywords: Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Sleep Disturbance
Melatonin
ASD
ADHD
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 10-18 years and consistently living with parental (or legal guardian) supervision.
* Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).
* Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ\>70).
* Parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the Children's Sleep Habits Questionnaire.
* 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 medication (unless provider directed) during study participation.

Exclusion Criteria:

* Unwillingness to stop melatonin 2 months prior to enrollment in the study.
* Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).
* Adolescents who are not able to take oral medication.
* Adolescents who are visually impaired with known inability to detect light.
* Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).
* Unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial.

Primary outcomes:
measure: Actigraphy (Total Sleep Time)
timeFrame: To be worn daily for the entirety of the study (9 weeks total). Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)
measure: AARP- Abbreviated Acceptability Rating Profile
timeFrame: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)
Secondary outcomes:
measure: Urinary Melatonin
timeFrame: Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.
measure: PROMIS Pediatric Item Bank Sleep Related Impairment
timeFrame: Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.
measure: PROMIS Pediatric Item Bank Sleep Disturbance
timeFrame: Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.
measure: Cleveland Adolescent Sleepiness Questionnaire (CASQ)
timeFrame: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Center for Nursing Science
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Alyson E Hanish, PhD, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
citation: Gruber R, Somerville G, Bergmame L, Fontil L, Paquin S. School-based sleep education program improves sleep and academic performance of school-age children. Sleep Med. 2016 May;21:93-100. doi: 10.1016/j.sleep.2016.01.012. Epub 2016 Feb 15.