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

NCT ID: NCT03730194

Last Updated: 2023-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Sleep Disturbance

Keywords

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Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Sleep Disturbance Melatonin ASD ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Melatonin Only

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).

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

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

The Bedtime Bank Only

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).

Group Type EXPERIMENTAL

Bedtime Bank

Intervention Type 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.

Melatonin than Bedtime Bank

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Bedtime Bank

Intervention Type 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.

Melatonin than Melatonin+Bedtime Bank Combo

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Bedtime Bank

Intervention Type 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.

Bedtime Bank than Melatonin

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Bedtime Bank

Intervention Type 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.

Bedtime Bank than Bedtime Bank+Melatonin Combo

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

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

Bedtime Bank

Intervention Type 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.

Interventions

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Melatonin

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alyson E Hanish, PhD, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska Medical Center, Center for Nursing Science

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22438190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27448478 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1K01NR017465-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0775-18-FB

Identifier Type: -

Identifier Source: org_study_id