Clinical trial NCT04723719: Sleep IntervEntion as Symptom Treatment for ADHD
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Sleep
Adolescents
CBT
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: KU Leuven
First posted: 2021-01-26
Enrollment: 92
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with training group and control group.
Primary purpose: TREATMENT

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 months follow-up effectiveness of the blended CBT sleep intervention in adolescents with ADHD.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep architecture objective TST pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep architecture objective SOL pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep architecture objective SE pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep architecture objective NoA pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep architecture subjective TST pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep architecture subjective SOL pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep architecture subjective SE pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep architecture subjective NoA pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep architecture objective TST pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep architecture objective SOL pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep architecture objective SE pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep architecture objective NoA pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep architecture subjective TST pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep architecture subjective SOL pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep architecture subjective SE pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep architecture subjective NoA pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep problems SSHS pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep problems CSRQ pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep problems CSHQ pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep problems SSHS pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep problems CSRQ pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep problems CSHQ pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Sleep hygiene pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Sleep hygiene pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
Secondary outcomes:
measure: ADHD symptoms pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: ADHD symptoms pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Parent-adolescent conflict pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Parent-adolescent conflict pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Homework problems pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Academic competence pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Homework problems pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Academic competence pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Comorbidities: oppositional-defiant disorder pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Comorbidities: anxiety pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Comorbidities: depression pre-test to post-test
timeFrame: From pre-test to post-test (+- 8 weeks)
measure: Comorbidities: oppositional-defiant disorder pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Comorbidities: anxiety pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
measure: Comorbidities: depression pre-test to follow-up
timeFrame: From pre-test to follow-up (+-3 months after posttest)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UPC Leuven
state: Vlaams Brabant
Study officials:
affiliation: KU Leuven
name: Saskia Van der Oord, PhD
role: PRINCIPAL_INVESTIGATOR
References: