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

University of Nebraska40 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Sleep Disturbance

Interventions

MelatoninDIETARY_SUPPLEMENT

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

Bedtime BankBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Nebraska Medical Center, Center for Nursing Science

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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.

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)

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

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

Secondary Outcomes

Urinary Melatonin

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.

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

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

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

Data from ClinicalTrials.gov

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