CompletedNot Applicable

Sleep IntervEntion as Symptom Treatment for ADHD

Belgium92 participantsStarted 2021-01-28

Plain-language 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.

Who can participate

Age range13 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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

What they're measuring

Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test

Timeframe: From pre-test to post-test (+/-8 weeks)

Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test

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

Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Post-test

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

Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Post-test

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

Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test

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

Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test

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

Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Post-test

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

Trial details

NCT IDNCT04723719

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-07

Results submitted2024-11-13

View on ClinicalTrials.gov More ADHD trials

Plain-language summary

Who can participate

Age range13 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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

What they're measuring

Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test

Timeframe: From pre-test to post-test (+/-8 weeks)

Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test

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

Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Post-test

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

Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Post-test

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

Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test

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

Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test

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

Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Post-test

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