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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
| KU Leuven | OTHER |
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Up to 72% of adolescents with ADHD portray sleep problems. The most common sleep difficulties in adolescents with ADHD are initial insomnia, nocturnal awakenings, non-restorative or restless sleep. These difficulties seem to be causally related to increased ADHD symptom impairment, oppositional and depressive symptomatology, and functional impairments in daily life, resulting in a vicious circle of sleep problems and impairment. Thus, reducing sleep problems is an important intervention target. However, to date there is no evidence-based cognitive behavioral sleep treatment available. Sleep-focused treatments need adaptation towards this developmental phase/disorder for effectiveness, as ADHD and sleep problems are bi-directional. Therefore, a blended treatment targeting the core deficits integrating motivational interviewing, planning skills and sleep interventions is needed. Thus, the aim of this project is testing the short and 3-4 months follow-up effectiveness of the blended cognitive behavioral sleep intervention in adolescents with ADHD.
To test effectiveness a randomized controlled trial in conducted in which adolescents with ADHD and sleep problems are randomized to either their Treatment as Usual for ADHD or their Treatment as usual for ADHD combined with the SIESTA cognitive behavioral sleep interventions. Effects on sleep, ADHD behavior and co-occuring problems are assessed at pretest, post test and at 3-4 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIESTA training + treatment as usual for ADHD | Experimental | We developed a cognitive behavioral therapy for sleep problems in adolescents with ADHD. This includes seven individual sessions with the adolescent and two individual sessions with the parent(s)/guardian(s). Participants receive this CBT training called SIESTA next to their treatment as usual for ADHD symptomatology (mostly ADHD-medication). |
|
| Treatment as usual for ADHD only | Active Comparator | Participants continue their treatment as usual for ADHD (mostly ADHD-medication). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIESTA | Behavioral | SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test | objective (actigraphy) sleep architecture (specified as TST in hours and minutes) | From pre-test to post-test (+/-8 weeks) |
| Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test | objective (actigraphy) sleep architecture (specified as SOL in hours and minutes) | From pre-test to post-test (+- 8 weeks) |
| Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Post-test | objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage) | From pre-test to post-test (+- 8 weeks) |
| Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Post-test | Sleep architecture objective (actigraphy) sleep architecture (specified as Number of Awakenings) | From pre-test to post-test (+- 8 weeks) |
| Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test | subjective (sleep logs) sleep architecture (specified as TST in hours and minutes) | From pre-test to post-test (+- 8 weeks) |
| Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test | subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes) | From pre-test to post-test (+- 8 weeks) |
| Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Post-test |
| Measure | Description | Time Frame |
|---|---|---|
| DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Post-test | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: questions are scored on a 4-point Likert scale, with higher scores indicating a worse outcome, minimum 0 - maximum 54 | From pre-test to post-test (+- 8 weeks) |
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Inclusion Criteria:
Attending secondary education and between 13-17 years old
prior diagnosis of ADHD (any presentation) and confirmation of DSM-5 criteria of ADHD in current study
Displaying sleep problems for at least 3 nights per week for at least 3 months
estimated IQ≥80
stable ADHD medication use at least 4 weeks before start of treatment and no dose or medication type changes planned during active treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saskia Van der Oord, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPC Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40423708 | Result | Keuppens L, Marten F, Baeyens D, Boyer B, Roose A, Becker S, Danckaerts M, Van der Oord S. Effectiveness of a cognitive-behavioral sleep hygiene intervention for adolescents with ADHD: a randomized controlled trial. Eur Child Adolesc Psychiatry. 2025 Nov;34(11):3415-3426. doi: 10.1007/s00787-025-02755-0. Epub 2025 May 27. | |
| 37055205 |
| Label | URL |
|---|---|
| Study website containing articles, intervention materials, online module to train clinicians in providing the intervention, list of trained clinicians and supervisors | View source |
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Data will be stored in the data repository of the KU Leuven (research data repository https://rdr.kuleuven.be/). Upon request of researchers (see below for access criteria) anonymous data will be shared by secured transfer to other researchers
Data will be shared from May 2025 (all data processed/ RCT paper written). Data is available for 25 years after publication of our RCT paper.
All relevant pre-post and follow-up individual participant data outcomes of all adolescents (and their parents) that provided informed consent/participated in our study will be shared with researchers that are conducting an IPD meta-analysis or researchers thar are assessing another relevant research question. Before transfer data will be completely anonymized to the researchers that will receive the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | SIESTA Training + Treatment as Usual for ADHD | We developed a cognitive behavioral therapy for sleep problems in adolescents with ADHD. This includes seven individual sessions with the adolescent and two individual sessions with the parent(s)/guardian(s). Participants receive this CBT training called SIESTA next to their treatment as usual for ADHD symptomatology (mostly ADHD-medication). SIESTA: SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization. Treatment as usual for ADHD: Participants continue their treatment as usual for ADHD. |
| FG001 | Treatment as Usual for ADHD Only | Participants continue their treatment as usual for ADHD (mostly ADHD-medication). Treatment as usual for ADHD: Participants continue their treatment as usual for ADHD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall study (Pre-test) |
| |||||||||||||
| Intervention (SIESTA) |
| |||||||||||||
| Post-test |
| |||||||||||||
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SIESTA Training + Treatment as Usual for ADHD | We developed a cognitive behavioral therapy for sleep problems in adolescents with ADHD. This includes seven individual sessions with the adolescent and two individual sessions with the parent(s)/guardian(s). Participants receive this CBT training called SIESTA next to their treatment as usual for ADHD symptomatology (mostly ADHD-medication). SIESTA: SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization. Treatment as usual for ADHD: Participants continue their treatment as usual for ADHD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test | objective (actigraphy) sleep architecture (specified as TST in hours and minutes) | Posted | Mean | Standard Deviation | hours | From pre-test to post-test (+/-8 weeks) |
|
Adverse events were monitored only in the active treatment arm where there was weekly therapeutic contact with the adolescent (N=47) not in the TAU arm, AE were collected in the active treatment arm from week 1 to week 8 [during which the active treatment took place], in week 1 and 2 AE were spontaneously reported, from week 3 onwards the AE were explicitly asked from session 3 (from then on an established working relationship to ask about AE).
AE were monitored during the active treatment arm of SIESTA, by explicitly asking about events at danger to the adolescent by the clinician (e.g suicial threat). Documented events were reported immediately to the Ethical Committee Research at UZ/KU Leuven. For each event, the description, timing, severity, relationship to the study, and outcome were recorded.
Other adverse events/ mortality were/was not explicitly monitored/ no adolescents deceased during the study.
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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 | SIESTA Training + Treatment as Usual for ADHD | We developed a cognitive behavioral therapy for sleep problems in adolescents with ADHD. This includes seven individual sessions with the adolescent and two individual sessions with the parent(s)/guardian(s). Participants receive this CBT training called SIESTA next to their treatment as usual for ADHD symptomatology (mostly ADHD-medication). SIESTA: SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization. Treatment as usual for ADHD: Participants continue their treatment as usual for ADHD. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide ideation and threat | Psychiatric disorders | Systematic Assessment | Deemed not related to study protocol by Ethical Committee Research of UZ/KU Leuven, but external circumstances |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Saskia Van der Oord | KU Leuven | 016325824 | saskia.vanderoord@kuleuven.be |
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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 | Feb 13, 2023 | Jan 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Randomized Controlled Trial with training group and control group.
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Stratified permuted block randomization, controlling for ADHD medication use (yes/no), is done by a masked/independent researcher.
|
| Treatment as usual for ADHD | Other | Participants continue their treatment as usual for ADHD. |
|
|
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage) |
| From pre-test to post-test (+- 8 weeks) |
| Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Post-test | subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings) | From pre-test to post-test (+- 8 weeks) |
| Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Follow-up | objective (actigraphy) sleep architecture (specified as TST in hours and minutes) | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Follow-up | objective (actigraphy) sleep architecture (specified as SOL in hours and minutes) | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Follow-up | objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage) | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Follow-up | objective (actigraphy) sleep architecture (specified as NoA: Number of Awakenings) | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Follow-up | subjective (sleep logs) sleep architecture (specified as TST in hours and minutes) | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Follow-up | subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes) | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Follow-up | subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage) | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Follow-up | subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings) | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Problems SSHS [School Sleep Habits Survey] [ Pre-test to Post-test | subjective sleep problems assessed by questionnaires (SSHS) School Sleep Habits Survey: questions are scored on a 5-point Likert scale, with higher scores indicating a worse outcome, minimum 10 - maximum 50 | From pre-test to post-test (+- 8 weeks) |
| Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Post-test | subjective sleep problems assessed by questionnaires (CSRQ) Chronic Sleep Reduction Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 20 - maximum 60 | From pre-test to post-test (+- 8 weeks) |
| Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Post-test | subjective sleep problems assessed by questionnaires (CSHQ) Children Sleep Habits Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 33 - maximum 99 | From pre-test to post-test (+- 8 weeks) |
| Sleep Problems SSHS [School Sleep Habits Survey] Pre-test to Follow-up | subjective sleep problems assessed by questionnaires (SSHS) School Sleep Habits Survey: questions are scored on a 5-point Likert scale, with higher scores indicating a worse outcome, minimum 10 - maximum 50 | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Follow-up | subjective sleep problems assessed by questionnaires (CSRQ) Chronic Sleep Reduction Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 20 - maximum 60 | From pre-test to follow-up (+-3 months after posttest) |
| Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Follow-up | subjective sleep problems assessed by questionnaires (CSHQ) Children Sleep Habits Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 33 - maximum 99 | From pre-test to follow-up (+-3 months after posttest) |
| ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Post-test | subjective sleep hygiene assessed by questionnaires (ASHSr) Revised Adolescent Sleep Hygiene Scale: questions are scored on a 6-point Likert scale, with higher scores indicating a better outcome, minimum 1 - maximum 6 | From pre-test to post-test (+- 8 weeks) |
| ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Follow-up | subjective sleep hygiene assessed by questionnaires (ASHSr) Revised Adolescent Sleep Hygiene Scale: questions are scored on a 6-point Likert scale, with higher scores indicating a better outcome, minimum 1 - maximum 6 | From pre-test to follow-up (+-3 months after posttest) |
| DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Follow-up |
Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: questions are scored on a 4-point Likert scale, with higher scores indicating a worse outcome, minimum 0 - maximum 54 |
| From pre-test to follow-up (+-3 months after posttest) |
| CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Post-test | Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome | From pre-test to post-test (+- 8 weeks) |
| CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Follow-up | Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome | From pre-test to follow-up (+-3 months after posttest) |
| HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test | Assessed by parents (HPC) : rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome | From pre-test to post-test (+- 8 weeks) |
| CPS [Classroom Performance Scale] Academic Competence Pre-test to Post-test | Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome | From pre-test to post-test (+- 8 weeks) |
| HPC [Homework Problems Checklist] Homework Problems Pre-test to Follow-up | Assessed by parents (HPC) Homework Problems Checklist: rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome | From pre-test to follow-up (+-3 months after posttest) |
| CPS [Classroom Performance Scale] Academic Competence Pre-test to Follow-up | Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome | From pre-test to follow-up (+-3 months after posttest) |
| DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Post-test | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: rated on a 4-point Likert scale, minimum 0 - maximum 24, higher scores mean worse outcome | From pre-test to post-test (+- 8 weeks) |
| SCARED-R [Screen for Child Anxiety Related Emotional Disorders Comorbidities] Anxiety Pre-test to Post-test | Assessed by adolescent (SCARED-R) Screen for Child Anxiety Related Emotional Disorders: rated on a 3-point Likert scale, minimum 0 - maximum 82, higher scores indicate worse outcome | From pre-test to post-test (+- 8 weeks) |
| CDI [Children's Depression Inventory] Depression Pre-test to Post-test | Assessed by adolescent (CDI-2) Children's Depression Inventory, Second Edition: rated on a 3-point Likert scale, minimum 0 - maximum 56, higher scores indicate worse outcome | From pre-test to post-test (+- 8 weeks) |
| DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Follow-up | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: rated on a 4-point Likert scale, minimum 0 - maximum 24, higher scores mean worse outcome | From pre-test to follow-up (+-3 months after posttest) |
| SCARED-R [Screen for Child Anxiety Related Emotional Disorders] Anxiety Pre-test to Follow-up | Assessed by adolescent (SCARED-R) Screen for Child Anxiety Related Emotional Disorders: rated on a 3-point Likert scale, minimum 0 - maximum 82, higher scores indicate worse outcome | From pre-test to follow-up (+-3 months after posttest) |
| CDI [Children's Depression Inventory] Depression Pre-test to Follow-up | Assessed by adolescent (CDI-2) Children's Depression Inventory, Second Edition: rated on a 3-point Likert scale, minimum 0 - maximum 56, higher scores indicate worse outcome | From pre-test to follow-up (+-3 months after posttest) |
| Keuppens L, Marten F, Baeyens D, Boyer B, Danckaerts M, van der Oord S. Sleep IntervEntion as Symptom Treatment for ADHD (SIESTA)-Blended CBT sleep intervention to improve sleep, ADHD symptoms and related problems in adolescents with ADHD: Protocol for a randomised controlled trial. BMJ Open. 2023 Apr 13;13(4):e065355. doi: 10.1136/bmjopen-2022-065355. |
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| BG001 | Treatment as Usual for ADHD Only | Participants continue their treatment as usual for ADHD (mostly ADHD-medication). Treatment as usual for ADHD: Participants continue their treatment as usual for ADHD. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ADHD presentation | Count of Participants | Participants |
|
| OG001 |
| Treatment as Usual for ADHD Only |
Participants continue their treatment as usual for ADHD (mostly ADHD-medication). Treatment as usual for ADHD: Participants continue their treatment as usual for ADHD. |
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| Primary | Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test | objective (actigraphy) sleep architecture (specified as SOL in hours and minutes) | Posted | Mean | Standard Deviation | hours | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Post-test | objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage) | Posted | Mean | Standard Deviation | percentage | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Post-test | Sleep architecture objective (actigraphy) sleep architecture (specified as Number of Awakenings) | Posted | Mean | Standard Deviation | number of awakenings | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test | subjective (sleep logs) sleep architecture (specified as TST in hours and minutes) | Posted | Mean | Standard Deviation | hours | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test | subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes) | Posted | Mean | Standard Deviation | hours | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Post-test | subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage) | Posted | Mean | Standard Deviation | percentage | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Post-test | subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings) | Posted | Mean | Standard Deviation | number of awakenings | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Follow-up | objective (actigraphy) sleep architecture (specified as TST in hours and minutes) | Posted | Mean | Standard Deviation | hours | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Follow-up | objective (actigraphy) sleep architecture (specified as SOL in hours and minutes) | Posted | Mean | Standard Deviation | hours | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Follow-up | objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage) | Posted | Mean | Standard Deviation | percentage | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Follow-up | objective (actigraphy) sleep architecture (specified as NoA: Number of Awakenings) | Posted | Mean | Standard Deviation | number of awakenings | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Follow-up | subjective (sleep logs) sleep architecture (specified as TST in hours and minutes) | Posted | Mean | Standard Deviation | hours | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Follow-up | subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes) | Posted | Mean | Standard Deviation | hours | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Follow-up | subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage) | Posted | Mean | Standard Deviation | percentage | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Follow-up | subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings) | Posted | Mean | Standard Deviation | number of awakenings | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Problems SSHS [School Sleep Habits Survey] [ Pre-test to Post-test | subjective sleep problems assessed by questionnaires (SSHS) School Sleep Habits Survey: questions are scored on a 5-point Likert scale, with higher scores indicating a worse outcome, minimum 10 - maximum 50 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Post-test | subjective sleep problems assessed by questionnaires (CSRQ) Chronic Sleep Reduction Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 20 - maximum 60 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Post-test | subjective sleep problems assessed by questionnaires (CSHQ) Children Sleep Habits Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 33 - maximum 99 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Primary | Sleep Problems SSHS [School Sleep Habits Survey] Pre-test to Follow-up | subjective sleep problems assessed by questionnaires (SSHS) School Sleep Habits Survey: questions are scored on a 5-point Likert scale, with higher scores indicating a worse outcome, minimum 10 - maximum 50 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Follow-up | subjective sleep problems assessed by questionnaires (CSRQ) Chronic Sleep Reduction Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 20 - maximum 60 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Follow-up | subjective sleep problems assessed by questionnaires (CSHQ) Children Sleep Habits Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 33 - maximum 99 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Primary | ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Post-test | subjective sleep hygiene assessed by questionnaires (ASHSr) Revised Adolescent Sleep Hygiene Scale: questions are scored on a 6-point Likert scale, with higher scores indicating a better outcome, minimum 1 - maximum 6 | Posted | Mean | Standard Error | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Primary | ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Follow-up | subjective sleep hygiene assessed by questionnaires (ASHSr) Revised Adolescent Sleep Hygiene Scale: questions are scored on a 6-point Likert scale, with higher scores indicating a better outcome, minimum 1 - maximum 6 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Secondary | DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Post-test | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: questions are scored on a 4-point Likert scale, with higher scores indicating a worse outcome, minimum 0 - maximum 54 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Secondary | DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Follow-up | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: questions are scored on a 4-point Likert scale, with higher scores indicating a worse outcome, minimum 0 - maximum 54 | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Secondary | CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Post-test | Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Secondary | CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Follow-up | Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Secondary | HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test | Assessed by parents (HPC) : rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome | Posted | Mean | Standard Error | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Secondary | CPS [Classroom Performance Scale] Academic Competence Pre-test to Post-test | Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Secondary | HPC [Homework Problems Checklist] Homework Problems Pre-test to Follow-up | Assessed by parents (HPC) Homework Problems Checklist: rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Secondary | CPS [Classroom Performance Scale] Academic Competence Pre-test to Follow-up | Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Secondary | DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Post-test | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: rated on a 4-point Likert scale, minimum 0 - maximum 24, higher scores mean worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Secondary | SCARED-R [Screen for Child Anxiety Related Emotional Disorders Comorbidities] Anxiety Pre-test to Post-test | Assessed by adolescent (SCARED-R) Screen for Child Anxiety Related Emotional Disorders: rated on a 3-point Likert scale, minimum 0 - maximum 82, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Secondary | CDI [Children's Depression Inventory] Depression Pre-test to Post-test | Assessed by adolescent (CDI-2) Children's Depression Inventory, Second Edition: rated on a 3-point Likert scale, minimum 0 - maximum 56, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to post-test (+- 8 weeks) |
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| Secondary | DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Follow-up | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: rated on a 4-point Likert scale, minimum 0 - maximum 24, higher scores mean worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Secondary | SCARED-R [Screen for Child Anxiety Related Emotional Disorders] Anxiety Pre-test to Follow-up | Assessed by adolescent (SCARED-R) Screen for Child Anxiety Related Emotional Disorders: rated on a 3-point Likert scale, minimum 0 - maximum 82, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| Secondary | CDI [Children's Depression Inventory] Depression Pre-test to Follow-up | Assessed by adolescent (CDI-2) Children's Depression Inventory, Second Edition: rated on a 3-point Likert scale, minimum 0 - maximum 56, higher scores indicate worse outcome | Posted | Mean | Standard Deviation | score on a scale | From pre-test to follow-up (+-3 months after posttest) |
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| 0 |
| 47 |
| 1 |
| 47 |
| 0 |
| 47 |
| EG001 | Treatment as Usual for ADHD Only | Participants continue their treatment as usual for ADHD (mostly ADHD-medication). Treatment as usual for ADHD: Participants continue their treatment as usual for ADHD. | 0 | 0 | 0 | 0 | 0 | 0 |
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Not provided
Not provided
| Combined |
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Sample size was determined based on power analysis; a CBT sleep study in adolescents without ADHD showed a large effect on sleep and medium effect on ADHD symptoms; therefore a moderate to large effect size was anticipated. Using G*power, at least 40 participants per condition were necessary (power .8/alpha .05); to account for potential drop-outs an additional 15% was recruited, resulting in 92 participants (Keuppens et al., 2023).