Sleep IntervEntion as Symptom Treatment for ADHD (SIESTA)

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.

Study Overview

• Status: Completed
• Conditions: Sleep; ADHD; CBT; Adolescents
• Intervention / Treatment: Behavioral: SIESTA; Other: Treatment as usual for 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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UPC Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Attending secondary education and between 13-17 years old
2. prior diagnosis of ADHD (any presentation) and confirmation of DSM-5 criteria of ADHD in current study

3. Displaying sleep problems for at least 3 nights per week for at least 3 months

   1. sleep onset latency of at least 20-30 minutes
   2. and/or wake after sleep onset greater than 30 min
   3. and/or an average sleep time of less than 7 hours
   4. and at least one poor sleep hygiene practice
   5. and experienced distress as indicated by parent/guardian and/or adolescent.
4. estimated IQ≥80
5. 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:

1. 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
2. acute crisis situation at home
3. physical problems that interfere with sleep (e.g. pain) or medical disorders and related medication that could affect sleep
4. participation in a behaviorally based sleep intervention in the 6 months prior to our study
5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: SIESTA; 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; Other: Treatment as usual for ADHD; Participants continue their treatment as usual for ADHD.; Other Names: TAU
Active Comparator: Treatment as usual for ADHD only; Participants continue their treatment as usual for ADHD (mostly ADHD-medication).	Other: Treatment as usual for ADHD; Participants continue their treatment as usual for ADHD.; Other Names: TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven; Research Foundation Flanders
• Investigators: Principal Investigator: Saskia Van der Oord, PhD, KU Leuven

Publications and helpful links

General 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.
• 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.

Helpful Links

• Study website containing articles, intervention materials, online module to train clinicians in providing the intervention, list of trained clinicians and supervisors

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): November 7, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity; Therapeutics
• Other Study ID Numbers: UZ Leuven (UZ leuven)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No