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Completed

NCT Number: NCT04723719

Sleep IntervEntion as Symptom Treatment for 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.

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Key information

Conditions

ADHD Adolescents Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders CBT Mental Disorders Neurodevelopmental Disorders Sleep

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPC Leuven

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

SIESTA

Behavioral

SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.

Other names: Sleep IntervEntion as Symptom Treatment for ADHD

Treatment as usual for ADHD

Other

Participants continue their treatment as usual for ADHD.

Other names: TAU

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

Secondary outcomes

  1. DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Post-test

    Time frame: From pre-test to post-test (+- 8 weeks)

    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

  2. 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)

    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

  3. CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Post-test

    Time frame: From pre-test to post-test (+- 8 weeks)

    Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome

  4. CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Follow-up

    Time frame: From pre-test to follow-up (+-3 months after posttest)

    Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome

  5. HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test

    Time frame: From pre-test to post-test (+- 8 weeks)

    Assessed by parents (HPC)

    : rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome

  6. CPS [Classroom Performance Scale] Academic Competence Pre-test to Post-test

    Time frame: From pre-test to post-test (+- 8 weeks)

    Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome

  7. HPC [Homework Problems Checklist] Homework Problems Pre-test to Follow-up

    Time frame: From pre-test to follow-up (+-3 months after posttest)

    Assessed by parents (HPC)

    Homework Problems Checklist: rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome

  8. CPS [Classroom Performance Scale] Academic Competence Pre-test to Follow-up

    Time frame: From pre-test to follow-up (+-3 months after posttest)

    Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome

  9. DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Post-test

    Time frame: From pre-test to post-test (+- 8 weeks)

    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

  10. 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)

    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

  11. CDI [Children's Depression Inventory] Depression Pre-test to Post-test

    Time frame: From pre-test to post-test (+- 8 weeks)

    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

  12. 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)

    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

  13. 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)

    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

  14. CDI [Children's Depression Inventory] Depression Pre-test to Follow-up

    Time frame: From pre-test to follow-up (+-3 months after posttest)

    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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven
  • Research Foundation Flanders

Registry information

Official study 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

Acronym: SIESTA

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 26, 2021
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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