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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730194
• Other study ID #: 0775-18-FB
• Secondary ID: 1K01NR017465-01A
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Autism Spectrum Disorder
• Dyssomnias
• Hyperkinesis
• Neurodevelopmental Disorders
• Parasomnias
• Sleep Disturbance

Intervention

Dietary Supplement:
• Melatonin
Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime

Behavioral:
• Bedtime Bank
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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Center for Nursing Science	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actigraphy (Total Sleep Time)	Objective measure of sleep patterns based on the correlation between sleep-wake state and motor activity. A sleep diary was utilized to guide data analysis.	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)
Primary	AARP- Abbreviated Acceptability Rating Profile	Parents completed the Abbreviated Acceptability Rating Profile (AARP), which will be used to indicate minimal treatment acceptability. Parent(s) and adolescent completed a semi-structured interview to discuss treatment acceptability.; Min/Max Values: 8-48 Higher scores=more acceptable/better	Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)
Secondary	Urinary Melatonin	The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.	Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.
Secondary	PROMIS Pediatric Item Bank Sleep Related Impairment	An 8-item questionnaire used to measure self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours.; PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). Higher scores=worse sleep related impairment	Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.
Secondary	PROMIS Pediatric Item Bank Sleep Disturbance	An 8-item questionnaire used to measure self-reported perceptions of sleep quality, depth, and restoration. This includes perceived difficulties getting to sleep and staying asleep, as well as sleep satisfaction.; PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). Higher scores=worse sleep disturbance	Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.
Secondary	Cleveland Adolescent Sleepiness Questionnaire (CASQ)	A sixteen-item instrument used to measure daytime sleepiness in adolescents 11-17 years of age.; Score ranges between 16-80. Higher scores would indicate greater sleepiness	Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)