N/A N=92 Randomized Single-blind Treatment

Sleep IntervEntion as Symptom Treatment for ADHD

ADHD · Sleep · Adolescents · CBT

Bottom Line

View on ClinicalTrials.gov: NCT04723719 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Feb 2026

Primary outcome: Primary: Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test — 8.11; 7.94; 8.03; 8.07 hours — p=.17

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SIESTA (Behavioral); Treatment as usual for ADHD (Other)
Age: Pediatric · 13+ yrs
Sex: All
Sponsor: Universitaire Ziekenhuizen KU Leuven
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test	8.11; 7.94; 8.03; 8.07	.17
PRIMARY Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test	.56; .74; .54; .51	.3
PRIMARY Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Post-test	92; 90; 92; 92	.33
PRIMARY Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Post-test	40.79; 37.75; 39.95; 39.18	.92
PRIMARY Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test	7.57; 7.47; 7.62; 7.68	.74
PRIMARY Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test	1.06; 1.16; .77; .9	.65
PRIMARY Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Post-test	84; 83; 87; 87	.79
PRIMARY Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Post-test	.55; .43; .30; .26	.81
PRIMARY Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Follow-up	8.11; 7.94; 8.2; 8.11	.22
PRIMARY Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Follow-up	.56; .74; .40; .56	.09
PRIMARY Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Follow-up	92; 90; 94; 92	.07
PRIMARY Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Follow-up	40.79; 37.75; 40.7; 39.08	.61
PRIMARY Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Follow-up	7.57; 7.47; 7.78; 7.72	.82
PRIMARY Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Follow-up	1.06; 1.16; .64; .88	.23
PRIMARY Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Follow-up	84; 83; 89; 86	.37
PRIMARY Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Follow-up	.55; .43; .19; .29	.14
PRIMARY Sleep Problems SSHS [School Sleep Habits Survey] [ Pre-test to Post-test	21.77; 20.78; 19.52; 20.77	.04 sig
PRIMARY Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Post-test	41.83; 38.79; 36.25; 39.36	<.001 sig
PRIMARY Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Post-test	52.69; 52.19; 49.03; 51.95	.07
PRIMARY Sleep Problems SSHS [School Sleep Habits Survey] Pre-test to Follow-up	21.77; 20.78; 19.51; 19.71	.29
PRIMARY Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Follow-up	41.83; 38.79; 36.21; 36.85	.11
PRIMARY Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Follow-up	52.69; 52.19; 49.00; 50.89	.39
PRIMARY ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Post-test	4.23; 4.30; 4.55; 4.18	<.001 sig
PRIMARY ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Follow-up	4.23; 4.30; 4.47; 4.34	.005 sig
SECONDARY DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Post-test	27.15; 28.24; 24.04; 24.56	.97
SECONDARY DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Follow-up	27.15; 28.24; 22.78; 22.26	.61
SECONDARY CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Post-test	12.79; 12.11; 11.78; 11.22	.94
SECONDARY CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Follow-up	12.79; 12.11; 10.79; 9.75	.91
SECONDARY HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test	45.31; 46.6; 42.59; 46.08	.17
SECONDARY CPS [Classroom Performance Scale] Academic Competence Pre-test to Post-test	40.12; 34.80; 38.60; 36.52	.75
SECONDARY HPC [Homework Problems Checklist] Homework Problems Pre-test to Follow-up	45.31; 46.6; 40.88; 43.12	.62
SECONDARY CPS [Classroom Performance Scale] Academic Competence Pre-test to Follow-up	40.12; 34.80; 40.07; 37.28	.77
SECONDARY DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Post-test	7.04; 7.21; 6.19; 6.68	.47
SECONDARY SCARED-R [Screen for Child Anxiety Related Emotional Disorders Comorbidities] Anxiety Pre-test to Post-test	39.58; 40.65; 32.51; 40.40	.06
SECONDARY CDI [Children's Depression Inventory] Depression Pre-test to Post-test	15.52; 15.97; 12.48; 15.98	.007 sig
SECONDARY DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Follow-up	7.04; 7.21; 6.63; 5.41	.05
SECONDARY SCARED-R [Screen for Child Anxiety Related Emotional Disorders] Anxiety Pre-test to Follow-up	39.58; 40.65; 28.94; 37.67	.59
SECONDARY CDI [Children's Depression Inventory] Depression Pre-test to Follow-up	15.52; 15.97; 11.26; 13.67	.62

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04723719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.