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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01NR017465-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin Only | Experimental | 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). |
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| The Bedtime Bank Only | Experimental | 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). |
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| Melatonin than Bedtime Bank | Experimental | 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. |
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| Melatonin than Melatonin+Bedtime Bank Combo | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Dietary Supplement | Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Melatonin | The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyson E Hanish, PhD, MSN, RN | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center, Center for Nursing Science | Omaha | Nebraska | 68198-5330 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22438190 | Background | 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. | |
| 27448478 | Background | 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. |
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See uploaded study protocol that includes recruitment details.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | Melatonin Then 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. |
| FG003 | Melatonin Then 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. |
| FG004 | Bedtime Bank Then 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. |
| FG005 | Bedtime Bank Then 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 ill take 3 mg of melatonin 30 minutes before bedtime for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Stage Treatment |
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| Second Stage Treatment |
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This trial is a pilot SMART design. At the first stage randomization participants were randomly assigned to "Melatonin" Only or "Bedtime Bank Only". The "Combination" intervention is not an option until the second stage randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | First Stage Melatonin | Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime. Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime |
| BG001 | First Stage Bedtime Bank |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8). Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders. | Posted | Mean | Standard Deviation | Time (hours.minutes of nightly sleep) | 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) |
|
Adverse events were monitored by the Data Safety Monitoring Board at the University of Nebraska Medical Center in conjunction with IRB protocols. Adverse event data were collected over the 2 years of the study (2019-2021) from initial consent to end of the trials (approximately 9 weeks).
Adverse events were reported to the DSMB per university protocol. AEs were monitored/assessed according to the intervention received in stage one or stage two. 1 participant had abdominal pain during the baseline week, unrelated to the intervention. 4 participants had mild skin irritation potentially due to wearing the wrist actigraph device (unrelated to intervention). All participants recovered prior to study ending. All-Cause Mortality was not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin Only | Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime. Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
This K01 study was a pilot feasibility SMART design, which will inform implementation of a future full-scale SMART design to construct adaptive biobehavioral sleep intervention strategies. Pilot SMARTs provide preliminary knowledge about the direction of the effect, and the aims focus on preliminary knowledge; however, conducting formal tests of outcomes or effect size estimation is not justified.
The COVID-19 pandemic began March 2020, and may have impact on study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alyson E Hanish | University of Nebraska Medical Center | 402-559-6731 | alyson.hanish@unmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2021 | Jan 25, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 27, 2020 | Feb 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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.
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| Bedtime Bank than Melatonin | Experimental | 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. |
|
| Bedtime Bank than Bedtime Bank+Melatonin Combo | Experimental | 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. |
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| 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. |
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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 |
| 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 | Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE. |
| 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 | Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8) |
| Protocol Violation |
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| COMPLETED |
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| NOT COMPLETED |
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Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diagnosis | Count of Participants | Participants |
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| OG001 | First Stage Bedtime Bank | Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention. 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. |
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| Primary | 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 | Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8). Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders. | Posted | Mean | Standard Deviation | units on a scale | Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8) |
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| Secondary | Urinary Melatonin | The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin. | First morning void urinary 6-sulphatoxymelatonin (Urine 6SM). Urine 6SM concentrations were expressed in ng per mg of creatinine (ng/mg Cr) to control for renal function and dilution of urine. | Posted | Mean | Standard Deviation | ng/mg Cr | Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group. |
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| Secondary | 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 | Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score. Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders. | Posted | Mean | Standard Error | T-score | Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score. |
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| Secondary | 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 | Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE. Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders. | Posted | Mean | Standard Error | T score | Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE. |
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| Secondary | 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 | Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8). Data was analyzed based on first stage randomization regardless of whether participants were responders or non-responders. | Posted | Mean | Standard Deviation | units on a scale | Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8) |
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| 0 |
| 0 |
| 0 |
| 27 |
| 3 |
| 27 |
| EG001 | Bedtime Bank Only | Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention. 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. | 0 | 0 | 0 | 26 | 2 | 26 |
| EG002 | Combination (Melatonin+Bedtime Bank) | Participants in this arm will take 3 mg melatonin 30 minutes before bedtime and utilize the Bedtime Bank, a behavioral sleep intervention. Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime 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. | 0 | 0 | 0 | 13 | 0 | 13 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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