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

University of Nebraska

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder; Sleep Disturbance

Treatments: Behavioral: Bedtime Bank; Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03730194

1K01NR017465-01A1 (U.S. NIH Grant/Contract)

0775-18-FB

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 6 patient groups

Melatonin Only

Experimental group

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).

Treatment:

Dietary Supplement: Melatonin

The Bedtime Bank Only

Experimental group

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).

Treatment:

Behavioral: Bedtime Bank

Melatonin than Bedtime Bank

Experimental group

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.

Treatment:

Behavioral: Bedtime Bank

Dietary Supplement: Melatonin

Melatonin than Melatonin+Bedtime Bank Combo

Experimental group

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.

Treatment:

Behavioral: Bedtime Bank

Dietary Supplement: Melatonin

Bedtime Bank than Melatonin

Experimental group

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.

Treatment:

Behavioral: Bedtime Bank

Dietary Supplement: Melatonin

Bedtime Bank than Bedtime Bank+Melatonin Combo

Experimental group

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.

Treatment:

Behavioral: Bedtime Bank

Dietary Supplement: Melatonin