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Completed

NCT Number: NCT03730194

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

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).

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Key information

Conditions

Autism Spectrum Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder Attention Deficit and Disruptive Behavior Disorders Child Development Disorders, Pervasive Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Parasomnias Sleep Disturbance Sleep Wake Disorders

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center, Center for Nursing Science

Omaha, Nebraska, 68198-5330, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

melatonin

Dietary Supplement

Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime

Bedtime Bank

Behavioral

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 outcomes

  1. Actigraphy (Total Sleep Time)

    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)

    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.

  2. AARP- Abbreviated Acceptability Rating Profile

    Time frame: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)

    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 outcomes

  1. Urinary Melatonin

    Time frame: Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.

    The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.

  2. PROMIS Pediatric Item Bank Sleep Related Impairment

    Time frame: Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.

    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

  3. PROMIS Pediatric Item Bank Sleep Disturbance

    Time frame: Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.

    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

  4. Cleveland Adolescent Sleepiness Questionnaire (CASQ)

    Time frame: Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)

    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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2018
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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