protocolSection identificationModule nctId: NCT06351930, orgStudyIdInfo id: EA210473, briefTitle: CBT for Insomnia in Adolescents With ADHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Kwai Chung Hospital, Hong Kong, descriptionModule briefSummary: Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms as well as overall functional improvement., conditionsModule conditions: Insomnia, conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomised, assessor-blind, parallel group controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: CBT-I + UC group, outcomesModule primaryOutcomes measure: Change in Insomnia Symptoms, secondaryOutcomes measure: Change in ADHD Symptoms (Self-report), secondaryOutcomes measure: Change in Internalising and Externalising Symptoms (Parent-rated), secondaryOutcomes measure: Change in depressive symptoms (Self-report), secondaryOutcomes measure: Change in anxiety symptoms (Self-report), secondaryOutcomes measure: Change in Sleep Diary Measure - Time in Bed (TIB), secondaryOutcomes measure: Change in Sleep Diary Measure - Total Sleep Time (TST), secondaryOutcomes measure: Change in Sleep Diary Measure - Sleep Onset Latency (SOL), secondaryOutcomes measure: Change in Sleep Diary Measure - Wake After Sleep Onset (WASO), secondaryOutcomes measure: Change in Sleep Diary Measure - Sleep Efficiency (SE), secondaryOutcomes measure: Change in Objective Sleep Measures - Time in Bed (TIB), secondaryOutcomes measure: Change in Objective Sleep Measures - Total Sleep Time (TST), secondaryOutcomes measure: Change in Objective Sleep Measures - Sleep Onset Latency (SOL), secondaryOutcomes measure: Change in Objective Sleep Measures - Wake After Sleep Onset (WASO), secondaryOutcomes measure: Change in Objective Sleep Measures - Sleep Efficiency (SE), secondaryOutcomes measure: Change in Individual Beliefs and Attitude about Sleep, secondaryOutcomes measure: Change in Adolescent Sleep Hygiene, secondaryOutcomes measure: Change in Quality of Life, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Waiyan Vivian CHIU, Clinical Psychologist, role: CONTACT, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Shirley X Li, PhD, DClinPsy, role: CONTACT, phone: 852-39177035, email: shirley.li@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False