Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT03730194
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alyson.hanish@unmc.edu', 'phone': '402-559-6731', 'title': 'Alyson E Hanish', 'organization': 'University of Nebraska Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.\n\nThe COVID-19 pandemic began March 2020, and may have impact on study results.'}}, 'adverseEventsModule': {'timeFrame': '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).', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Melatonin Only', 'description': 'Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 0, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bedtime Bank Only', 'description': 'Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.\n\nBedtime 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.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 0, 'otherNumAffected': 2, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Combination (Melatonin+Bedtime Bank)', 'description': 'Participants in this arm will take 3 mg melatonin 30 minutes before bedtime and utilize the Bedtime Bank, a behavioral sleep intervention.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime\n\nBedtime 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.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Actigraphy (Total Sleep Time)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Stage Melatonin', 'description': 'Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime'}, {'id': 'OG001', 'title': 'First Stage Bedtime Bank', 'description': 'Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.\n\nBedtime 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.08', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '7.03', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '7.16', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '7.01', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '7.06', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': '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.', 'unitOfMeasure': 'Time (hours.minutes of nightly sleep)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'AARP- Abbreviated Acceptability Rating Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Stage Melatonin', 'description': 'Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime'}, {'id': 'OG001', 'title': 'First Stage Bedtime Bank', 'description': 'Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.\n\nBedtime 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.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '38.84', 'spread': '7.19', 'groupId': 'OG000'}, {'value': '34.00', 'spread': '6.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '38.84', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '37.89', 'spread': '5.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)', 'description': '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.\n\nMin/Max Values: 8-48 Higher scores=more acceptable/better', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Urinary Melatonin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Stage Melatonin', 'description': 'Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime'}, {'id': 'OG001', 'title': 'First Stage Bedtime Bank', 'description': 'Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.\n\nBedtime 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.90', 'spread': '43.67', 'groupId': 'OG000'}, {'value': '78.58', 'spread': '31.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.', 'description': 'The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.', 'unitOfMeasure': 'ng/mg Cr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS Pediatric Item Bank Sleep Related Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Stage Melatonin', 'description': 'Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime'}, {'id': 'OG001', 'title': 'First Stage Bedtime Bank', 'description': 'Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.\n\nBedtime 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.73', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '58.37', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.87', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '53.56', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.76', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '51.62', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.', 'description': 'An 8-item questionnaire used to measure self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours.\n\nPROMIS 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', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'PROMIS Pediatric Item Bank Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Stage Melatonin', 'description': 'Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime'}, {'id': 'OG001', 'title': 'First Stage Bedtime Bank', 'description': 'Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.\n\nBedtime 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.37', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '64.160', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.46', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '59.20', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.57', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '56.65', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.', 'description': '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.\n\nPROMIS 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', 'unitOfMeasure': 'T score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Cleveland Adolescent Sleepiness Questionnaire (CASQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'First Stage Melatonin', 'description': 'Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime'}, {'id': 'OG001', 'title': 'First Stage Bedtime Bank', 'description': 'Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.\n\nBedtime 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.70', 'spread': '7.994', 'groupId': 'OG000'}, {'value': '41.50', 'spread': '10.430', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.21', 'spread': '8.911', 'groupId': 'OG000'}, {'value': '38.79', 'spread': '7.052', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.74', 'spread': '6.723', 'groupId': 'OG000'}, {'value': '38.42', 'spread': '8.952', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)', 'description': 'A sixteen-item instrument used to measure daytime sleepiness in adolescents 11-17 years of age.\n\nScore ranges between 16-80. Higher scores would indicate greater sleepiness', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Melatonin Only', 'description': 'In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.\n\nIn 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).'}, {'id': 'FG001', 'title': 'Bedtime Bank Only', 'description': 'In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.\n\nIn 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).'}, {'id': 'FG002', 'title': 'Melatonin Then Bedtime Bank', 'description': 'In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.\n\nIn stage 2, non-responders to melatonin will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.'}, {'id': 'FG003', 'title': 'Melatonin Then Melatonin+Bedtime Bank Combo', 'description': 'In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks\n\nIn 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.'}, {'id': 'FG004', 'title': 'Bedtime Bank Then Melatonin', 'description': 'In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.\n\nIn stage 2, non-responders to The Bedtime Bank will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.'}, {'id': 'FG005', 'title': 'Bedtime Bank Then Bedtime Bank+Melatonin Combo', 'description': 'In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.\n\nIn 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.'}], 'periods': [{'title': 'First Stage Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'This study utilizes a SMART Design.\n\n1 participant from the "Melatonin Only" group withdrew from the study. 1 participant from the "Bedtime Bank Only" group withdrew from the study.\n\n3 participants in the "Melatonin Only" group \\& 3 participants in the "Bedtime Bank Only" group did not complete all study requirements (e.g., minimum actigraph days). These 6 participants remained in the pilot SMART study (did not want to withdraw), and repeated there assigned treatment in the Second Stage.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Stage Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '\\*\\* 3 participants did not complete all study requirements during the first stage intervention (noted as protocol violation). Melatonin intervention repeated.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': '\\*\\* 3 participants did not complete all study requirements during the first stage intervention (noted as protocol violation). The Bedtime Bank intervention repeated.', 'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'See uploaded study protocol that includes recruitment details.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'First Stage Melatonin', 'description': 'Stage 1: Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime.\n\nMelatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime'}, {'id': 'BG001', 'title': 'First Stage Bedtime Bank', 'description': 'Stage 1: Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention.\n\nBedtime 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.45', 'spread': '2.95', 'groupId': 'BG000'}, {'value': '13.00', 'spread': '2.05', 'groupId': 'BG001'}, {'value': '13.23', 'spread': '2.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis', 'classes': [{'title': 'Autism (with or without ADHD)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'ADHD only', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '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.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-23', 'size': 431410, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-25T15:29', 'hasProtocol': True}, {'date': '2020-10-27', 'size': 212454, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-01T16:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2018-10-31', 'resultsFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2018-11-02', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-03', 'studyFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actigraphy (Total Sleep Time)', 'timeFrame': '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)', 'description': '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.'}, {'measure': 'AARP- Abbreviated Acceptability Rating Profile', 'timeFrame': 'Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Week 4 and Week 8)', 'description': '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.\n\nMin/Max Values: 8-48 Higher scores=more acceptable/better'}], 'secondaryOutcomes': [{'measure': 'Urinary Melatonin', 'timeFrame': 'Completed once during the baseline week prior to first stage randomization. Results reported by first stage randomization group.', 'description': 'The Genway Biotech Melatonin ELISA Kit (San Diego, CA) will allow for the analysis and quantification of endogenous melatonin.'}, {'measure': 'PROMIS Pediatric Item Bank Sleep Related Impairment', 'timeFrame': 'Baseline, Week 4, & Week 8-PROMIS Pediatric Item Bank Sleep Related Impairment t-score.', 'description': 'An 8-item questionnaire used to measure self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours.\n\nPROMIS 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'}, {'measure': 'PROMIS Pediatric Item Bank Sleep Disturbance', 'timeFrame': 'Baseline, Week 4, & Week 8 PROMIS Pediatric Item Bank Sleep Disturbance t-scores/SE.', 'description': '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.\n\nPROMIS 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'}, {'measure': 'Cleveland Adolescent Sleepiness Questionnaire (CASQ)', 'timeFrame': 'Data Reported on First Stage Randomization of Melatonin vs. Bedtime Bank (Data Collected at: Baseline, Week 4, and Week 8)', 'description': 'A sixteen-item instrument used to measure daytime sleepiness in adolescents 11-17 years of age.\n\nScore ranges between 16-80. Higher scores would indicate greater sleepiness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism Spectrum Disorder', 'Attention Deficit Hyperactivity Disorder', 'Sleep Disturbance', 'Melatonin', 'ASD', 'ADHD'], 'conditions': ['Autism Spectrum Disorder', 'Attention Deficit Hyperactivity Disorder', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'pmid': '22438190', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27448478', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 10-18 years and consistently living with parental (or legal guardian) supervision.\n* Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).\n* Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ\\>70).\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Unwillingness to stop melatonin 2 months prior to enrollment in the study.\n* Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).\n* Adolescents who are not able to take oral medication.\n* Adolescents who are visually impaired with known inability to detect light.\n* Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).\n* Unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial."}, 'identificationModule': {'nctId': 'NCT03730194', 'briefTitle': 'A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders', 'orgStudyIdInfo': {'id': '0775-18-FB'}, 'secondaryIdInfos': [{'id': '1K01NR017465-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K01NR017465-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melatonin Only', 'description': 'In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.\n\nIn 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).', 'interventionNames': ['Dietary Supplement: Melatonin']}, {'type': 'EXPERIMENTAL', 'label': 'The Bedtime Bank Only', 'description': 'In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.\n\nIn 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).', 'interventionNames': ['Behavioral: Bedtime Bank']}, {'type': 'EXPERIMENTAL', 'label': 'Melatonin than Bedtime Bank', 'description': 'In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.\n\nIn stage 2, non-responders to melatonin will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.', 'interventionNames': ['Dietary Supplement: Melatonin', 'Behavioral: Bedtime Bank']}, {'type': 'EXPERIMENTAL', 'label': 'Melatonin than Melatonin+Bedtime Bank Combo', 'description': 'In stage 1, participants in this arm will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.\n\nIn 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.', 'interventionNames': ['Dietary Supplement: Melatonin', 'Behavioral: Bedtime Bank']}, {'type': 'EXPERIMENTAL', 'label': 'Bedtime Bank than Melatonin', 'description': 'In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.\n\nIn stage 2, non-responders to The Bedtime Bank will take 3 mg of melatonin 30 minutes before bedtime for 4 weeks.', 'interventionNames': ['Dietary Supplement: Melatonin', 'Behavioral: Bedtime Bank']}, {'type': 'EXPERIMENTAL', 'label': 'Bedtime Bank than Bedtime Bank+Melatonin Combo', 'description': 'In stage 1, participants in this arm will utilize The Bedtime Bank, a behavioral sleep intervention, for 4 weeks.\n\nIn 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.', 'interventionNames': ['Dietary Supplement: Melatonin', 'Behavioral: Bedtime Bank']}], 'interventions': [{'name': 'Melatonin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime', 'armGroupLabels': ['Bedtime Bank than Bedtime Bank+Melatonin Combo', 'Bedtime Bank than Melatonin', 'Melatonin Only', 'Melatonin than Bedtime Bank', 'Melatonin than Melatonin+Bedtime Bank Combo']}, {'name': 'Bedtime Bank', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Bedtime Bank than Bedtime Bank+Melatonin Combo', 'Bedtime Bank than Melatonin', 'Melatonin than Bedtime Bank', 'Melatonin than Melatonin+Bedtime Bank Combo', 'The Bedtime Bank Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198-5330', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center, Center for Nursing Science', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Alyson E Hanish, PhD, MSN, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}