Back to resultsA SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Primary Purpose
Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Bedtime Bank
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance, Melatonin, ASD, ADHD
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.
Sites / Locations
- University of Nebraska Medical Center, Center for Nursing Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Melatonin Only
The Bedtime Bank Only
Melatonin than Bedtime Bank
Melatonin than Melatonin+Bedtime Bank Combo
Bedtime Bank than Melatonin
Bedtime Bank than Bedtime Bank+Melatonin Combo
Arm Description
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks).
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks).
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, non-responders to melatonin will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. In stage 2, non-responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, non-responders to The Bedtime Bank will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks. In stage 2, non-responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Urinary Melatonin
The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.
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
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
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
Full Information
NCT ID
NCT03730194
First Posted
October 31, 2018
Last Updated
April 3, 2023
Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT03730194
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance
Keywords
Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Sleep Disturbance, Melatonin, ASD, ADHD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melatonin Only
Arm Type
Experimental
Arm Description
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 2, responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks).
Arm Title
The Bedtime Bank Only
Arm Type
Experimental
Arm Description
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 2, responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks).
Arm Title
Melatonin than Bedtime Bank
Arm Type
Experimental
Arm Description
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 2, non-responders to melatonin will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
Arm Title
Melatonin than Melatonin+Bedtime Bank Combo
Arm Type
Experimental
Arm Description
In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
In stage 2, non-responders to melatonin will take 3 mg of melatonin 30 minutes before bedtime for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
Arm Title
Bedtime Bank than Melatonin
Arm Type
Experimental
Arm Description
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 2, non-responders to The Bedtime Bank will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
Arm Title
Bedtime Bank than Bedtime Bank+Melatonin Combo
Arm Type
Experimental
Arm Description
In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.
In stage 2, non-responders to The Bedtime Bank will utilize The Bedtime Bank, a behavioral sleep intervention for an additional 4 weeks (repeat stage 1, for a total of 8 weeks) AND take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
Intervention Type
Behavioral
Intervention Name(s)
Bedtime Bank
Intervention Description
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.
Primary Outcome Measure Information:
Title
Actigraphy (Total Sleep Time)
Description
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.
Time Frame
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)
Title
AARP- Abbreviated Acceptability Rating Profile
Description
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
Time Frame
Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)
Secondary Outcome Measure Information:
Title
Urinary Melatonin
Description
The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.
Time Frame
Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.
Title
PROMIS Pediatric Item Bank Sleep Related Impairment
Description
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
Time Frame
Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.
Title
PROMIS Pediatric Item Bank Sleep Disturbance
Description
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
Time Frame
Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.
Title
Cleveland Adolescent Sleepiness Questionnaire (CASQ)
Description
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
Time Frame
Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyson E Hanish, PhD, MSN, RN
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, Center for Nursing Science
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5330
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22438190
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.
Results Reference
background
PubMed Identifier
27448478
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.
Results Reference
background
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A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
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