Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT03047356
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2017-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2017-02-06', 'lastUpdatePostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achieving recommended sleep levels', 'timeFrame': '1 month', 'description': 'The main outcome measure was adapted from the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, \\& Kupfer, 1989), and was designed to tap both quantity and quality of sleep. Sleep quantity was assessed by asking: "How many hours of actual sleep do you normally get on a night before school? \\_\\_\\_\\_\\_\\_\\_\\_\\_ hours," "What time do you normally go to bed on a night before school? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ pm," and "What time do you normally get up on a school day? \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ am."'}], 'secondaryOutcomes': [{'measure': 'Self-regulation', 'timeFrame': '1 month', 'description': 'Sniehotta, Nagy, and Scholz\'s (2006) six items were used to capture three facets of action control (Karoly, 1993) on 7-point (+1 to +7) strongly disagree-strongly agree scales. (e.g., "During the last month I constantly monitored my sleep on the nights before school")'}, {'measure': 'Habit', 'timeFrame': '1 month', 'description': 'Gardner et al.\'s (2012) self-report behavioral automaticity index, which consists of four items measured on 7-point strongly disagree-strongly agree scales. The items are: "Getting 9 hours\' sleep on the nights before school is something I do automatically," "Getting 9 hours\' sleep on the nights before school is something I do without thinking," "Getting 9 hours\' sleep on the nights before school is something I do without having to consciously remember," and "Getting 9 hours\' sleep on the nights before school is something I start doing before I realize I\'m doing it."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental']}, 'descriptionModule': {'briefSummary': 'A trial that tests whether implementation intentions improve sleep among adoelescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 12-16 years\n\nExclusion Criteria:\n\n* Unable or unwilling to complete the question'}, 'identificationModule': {'nctId': 'NCT03047356', 'briefTitle': 'Sleep Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Effects of "If-then" Plans ("Implementation Intentions") on Adolescent Sleep', 'orgStudyIdInfo': {'id': 'Carding_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First-person "if-then" plan', 'description': 'Participants are asked to form "if-then" plans and the instructions are presented in the first person ("if I...then I..."). "Ifs" are critical situations, "thens" are appropriate responses.', 'interventionNames': ['Behavioral: "If-then" plans']}, {'type': 'EXPERIMENTAL', 'label': 'Second-person "if-then" plan', 'description': 'Participants are asked to form "if-then" plans and the instructions are presented in the second person ("if you...then you..."). "Ifs" are critical situations, "thens" are appropriate responses.', 'interventionNames': ['Behavioral: "If-then" plans']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Participants are presented with "ifs "(critical situations) and "thens" but are not asked to form "if-then" plans.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': '"If-then" plans', 'type': 'BEHAVIORAL', 'description': '"If-then" plans (or "implementation intentions") involve linking in memory critical situations (e.g., temptations) with appropriate responses (e.g., substitution)', 'armGroupLabels': ['First-person "if-then" plan', 'Second-person "if-then" plan']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Exposure to critical situations (e.g., temptations) and appropriate responses (e.g., substitution) but not linked in memory', 'armGroupLabels': ['Control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Health Psychology', 'investigatorFullName': 'Christopher Armitage', 'investigatorAffiliation': 'University of Manchester'}}}}