Sleep IntervEntion as Symptom Treatment for ADHD

NCT04723719 | Completed Results

• 1 other identifier: UZ Leuven
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ADHD; Sleep; CBT; Adolescents

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (14)

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

  From pre-test to post-test (+- 8 weeks)

• DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Follow-up

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

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

  From pre-test to post-test (+- 8 weeks)

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

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

• HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test

  From pre-test to post-test (+- 8 weeks)

Study Arms (2)

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).

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).

Other: Treatment as usual for ADHD

Interventions

SIESTA BEHAVIORAL

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

Also known as: Sleep IntervEntion as Symptom Treatment for ADHD

SIESTA training + treatment as usual for ADHD

Treatment as usual for ADHD OTHER

Participants continue their treatment as usual for ADHD.

Also known as: TAU

SIESTA training + treatment as usual for ADHD; Treatment as usual for ADHD only

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Research Foundation Flanders: collaborator
• KU Leuven: collaborator

Study Sites (1)

UPC Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 40423708 RESULT

• 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.

  PMID: 37055205 DERIVED

Related Links

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

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Prof. Saskia Van der Oord
• Organization: KU Leuven

saskia.vanderoord@kuleuven.be

016325824

Study Officials

• Saskia Van der Oord, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Stratified permuted block randomization, controlling for ADHD medication use (yes/no), is done by a masked/independent researcher.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Randomized Controlled Trial with training group and control group.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 26, 2021
• Study Start: January 28, 2021
• Primary Completion: November 7, 2023
• Study Completion: February 1, 2024
• Last Updated: February 13, 2026
• Results First Posted: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

BE (1)