ADHDSIESTANCT04723719
Sleep IntervEntion as Symptom Treatment for ADHD
A study testing SIESTA and Treatment as usual for ADHD in people with ADHD and Sleep, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- ADHD, Sleep, Adolescents
- What is being tested?
- SIESTA and Treatment as usual for ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jan 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- sleep onset latency of at least 20-30 minutes
- and/or wake after sleep onset greater than 30 min
- and/or an average sleep time of less than 7 hours
Show all 10Show fewer
- and at least one poor sleep hygiene practice
- and experienced distress as indicated by parent/guardian and/or adolescent.
- 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
Who cannot join
- the following comorbidities: sleep-breathing disorder, restless leg syndrome, narcolepsy, conduct disorder, depressive disorder with suicide risk or active suicidality, autism spectrum disorder, or substance use disorder, with an exception for nicotine
- acute crisis situation at home
- physical problems that interfere with sleep (e.g. pain) or medical disorders and related medication that could affect sleep
- participation in a behaviorally based sleep intervention in the 6 months prior to our study
- currently taking pharmacological medication for sleep (including melatonin), anxiety or depression. Participation will be allowed after a two-week wash-out period of the medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SIESTA Sleep IntervEntion as Symptom Treatment for ADHD - Blended CBT Sleep Intervention to Improve Sleep, ADHD Symptoms and Related Problems in Adolescents With ADHD
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.
Read the detailed description
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.
- Conditions
- ADHD, Sleep, Adolescents, CBT
- Being tested
- SIESTA, Treatment as usual for ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIESTABehavioural
Also called Sleep IntervEntion as Symptom Treatment for ADHD
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 ADHDOther
Also called TAU
Participants continue their treatment as usual for ADHD.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: SIESTA; Other: Treatment as usual for ADHD |
| Treatment as usual for ADHD only | Active comparator | Participants continue their treatment as usual for ADHD (mostly ADHD-medication). Receives: Other: Treatment as usual for ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From pre-test to post-test (+- 8 weeks)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From pre-test to follow-up (+-3 months after posttest)
Secondary outcomes (14)
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
Measured: From pre-test to post-test (+- 8 weeks)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From pre-test to follow-up (+-3 months after posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start28 Jan 2021
- Primary completion7 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with training group and control group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven
- Responsible party
- Principal investigator, Saskia Van der Oord, KU Leuven
- Investigators
- Saskia Van der Oord, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723719
- Sponsor's protocol ID
- UZ Leuven
- Acronym
- SIESTA
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2021
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 40423708Keuppens 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.
PubMed 37055205
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIESTA Sleep IntervEntion as Symptom Treatment for ADHD - Blended CBT Sleep Intervention to Improve Sleep, ADHD Symptoms and Related Problems in Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT04723719
- Acronym / sponsor ID
- SIESTA / UZ Leuven
- Conditions
- ADHD, Sleep, Adolescents, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with training group and control group.
| Arm | Type | Receives |
|---|---|---|
| SIESTA training + treatment as usual for ADHD | Experimental | Behavioral: SIESTA, Other: Treatment as usual for ADHDWe 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 | Other: Treatment as usual for ADHDParticipants continue their treatment as usual for ADHD (mostly ADHD-medication). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- the following comorbidities: sleep-breathing disorder, restless leg syndrome, narcolepsy, conduct disorder, depressive disorder with suicide risk or active suicidality, autism spectrum disorder, or substance use disorder, with an exception for nicotine
- acute crisis situation at home
- physical problems that interfere with sleep (e.g. pain) or medical disorders and related medication that could affect sleep
- participation in a behaviorally based sleep intervention in the 6 months prior to our study
- currently taking pharmacological medication for sleep (including melatonin), anxiety or depression. Participation will be allowed after a two-week wash-out period of the medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIESTAAlso: Sleep IntervEntion as Symptom Treatment for ADHDSIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization. | Behavioural | SIESTA training + treatment as usual for ADHD |
| Treatment as usual for ADHDAlso: TAUParticipants continue their treatment as usual for ADHD. | Other | SIESTA training + treatment as usual for ADHD, Treatment as usual for ADHD only |
Primary outcome
Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test
Time frame: From pre-test to post-test (+/-8 weeks)
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)
Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)
Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
Sleep architecture objective (actigraphy) sleep architecture (specified as Number of Awakenings)
Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)
Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)
Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings)
Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)
Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)
Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as NoA: Number of Awakenings)
Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)
Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)
Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings)
Sleep Problems SSHS [School Sleep Habits Survey] [ Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
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
Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
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
Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
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
Sleep Problems SSHS [School Sleep Habits Survey] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
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
Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
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
Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
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
ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
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
ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
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
14 secondary outcomes
DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
CPS [Classroom Performance Scale] Academic Competence Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
HPC [Homework Problems Checklist] Homework Problems Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
CPS [Classroom Performance Scale] Academic Competence Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
SCARED-R [Screen for Child Anxiety Related Emotional Disorders Comorbidities] Anxiety Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
CDI [Children's Depression Inventory] Depression Pre-test to Post-test
Time frame: From pre-test to post-test (+- 8 weeks)
DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Follow-up
Time frame: 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
Time frame: From pre-test to follow-up (+-3 months after posttest)
CDI [Children's Depression Inventory] Depression Pre-test to Follow-up
Time frame: From pre-test to follow-up (+-3 months after posttest)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40423708Keuppens 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.
- Derived from this study: PubMed 37055205Keuppens 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.
- Study website containing articles, intervention materials, online module to train clinicians in providing the intervention, list of trained clinicians and supervisorsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saskia Van der Oord, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIESTA and Treatment as usual for ADHD in people with ADHD and Sleep, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test (time frame: From pre-test to post-test (+/-8 weeks)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723719, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.