Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-03-11 @ 11:38 PM
Study NCT ID:
NCT03263156
Status:
UNKNOWN
Last Update Posted:
2021-04-27
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Brief Parent-based Sleep Intervention for ADHD Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-29', 'size': 790859, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-08-29T02:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-24', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-08-25', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Child: Change of child's sleep", 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': "Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ), and sleep problems rated by parent (none, mild, moderate, severe)"}], 'secondaryOutcomes': [{'measure': 'Child: Change of daytime sleepiness', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Pediatric Daytime Sleepiness Scale (PDSS) - parent report'}, {'measure': 'Child: Change of other sleep measures', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Daily sleep diary and actigraphic assessment for consecutive seven days'}, {'measure': 'Child: Change of ADHD symptoms', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report'}, {'measure': "Child: Change of child's behaviour & other clinical symptoms", 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report'}, {'measure': 'Child: Change of quality of life', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report'}, {'measure': 'Child: Change of cognitive performance (sustained attention)', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Continuous Performance Test (CPT)'}, {'measure': 'Child: Change of cognitive performance (auditory attention span)', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Digit Span'}, {'measure': 'Child: Change of cognitive performance (working memory)', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'N-back'}, {'measure': 'Child: Change of cognitive performance (cognitive processing)', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Letter-digit substitution task'}, {'measure': 'Child: Change of cognitive performance (cognitive flexibility)', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Bergs Card Sorting Test (BCST)'}, {'measure': 'Child: Change of cognitive performance (planning skills)', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Tower of London (TOL)'}, {'measure': 'Change of parental self-reported sleep quality', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Change of parental insomnia symptoms', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Insomnia Severity Index (ISI)'}, {'measure': 'Change of parental daytime sleepiness', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Epworth Sleepiness Questionnaire (ESS)'}, {'measure': 'Change of parental sleep parameters as measured by actigraphy', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Actigraphic sleep parameters'}, {'measure': 'Change of parental sleep hygiene practice', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Sleep Hygiene Index (SHI)'}, {'measure': 'Change of parental stress', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Parental Stress Index - Short Form (PSI-SF)'}, {'measure': 'Change of parental mood symptoms', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Depression Anxiety Stress Scales - 21 item (DASS-21)'}, {'measure': 'Change of parental daytime fatigue', 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Multidimensional Fatigue Inventory (MFI)'}, {'measure': "Parent's satisfaction to the treatment", 'timeFrame': 'Baseline, 1-week and 3-month posttreatment', 'description': 'Treatment satisfaction rating scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'ADHD', 'behavioural intervention', 'insomnia'], 'conditions': ['ADHD', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%, and often pose significant challenges and stress to the families. Sleep problems in ADHD children are strongly associated with the exacerbation of daytime symptoms, impaired physical health, and poor parental mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ADHD (aged 6-12). Eligible participants will be randomised to either intervention (two face-to-face consultation sessions and one follow-up phone call) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), one-week after the intervention (post-treatment), and 3 months after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 6-12 years old;\n* With a clinical diagnosis of ADHD (any subtype), as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);\n* With parent-reported insomnia (difficulty initiating sleep and/or maintaining sleep).\n\nExclusion Criteria:\n\n* Children with a serious medical condition (e.g. severe cerebral palsy) or intellectual disability (IQ\\<70);\n* Children with a neurological and/or medical condition that may lead to disordered sleep;\n* Suspected clinical sleep disorders (e.g. obstructive sleep apnea, OSA) that may potentially contribute to a disruption in sleep continuity and quality, as assessed by the Children's Sleep Habits Questionnaire (CSHQ). If the child is suspected of a clinical sleep disorder, he/she will be referred to appropriate services;\n* Children who are already receiving specialised help (behavioural intervention) for their sleep from a psychologist or at a specialized sleep clinic."}, 'identificationModule': {'nctId': 'NCT03263156', 'briefTitle': 'A Brief Parent-based Sleep Intervention for ADHD Children', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '30160604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': "The intervention will involve two face-to-face consultation sessions and one follow-up phone call with parents to help them learn sleep hygiene practices and specific behavioural strategies to improve their child's sleep and follow up on the progress.", 'interventionNames': ['Behavioral: Sleep hygiene practices and behavioural intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting-list control', 'description': 'Children in the waiting-list control group will receive usual clinical care.'}], 'interventions': [{'name': 'Sleep hygiene practices and behavioural intervention', 'type': 'BEHAVIORAL', 'description': "The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem for the next two weeks. The second session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. A follow-up phone call will be made two weeks later to provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kelly YC Lai, MRCPsych,FHKAM(Psych)', 'role': 'CONTACT', 'email': 'kellylai@cuhk.edu.hk', 'phone': '(852)26076025'}, {'name': 'Ka Sin Caroline Shea, FHKCPsy', 'role': 'CONTACT', 'email': 'carolinesks@gmail.com', 'phone': '(852)26076724'}], 'facility': 'Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shirley Xin Li, PhD,DClinPsy', 'role': 'CONTACT', 'email': 'shirley.li@hku.hk', 'phone': '852-39177035'}], 'facility': 'Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Shirley Xin Li, PhD,DClinPsy', 'role': 'CONTACT', 'email': 'shirley.li@hku.hk', 'phone': '852-39177035'}], 'overallOfficials': [{'name': 'Shirley Xin Li, PhD,DClinPsy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychology, The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Shirley Xin Li', 'investigatorAffiliation': 'The University of Hong Kong'}}}}