Sleep IntervEntion as Symptom Treatment for ADHD

Sleep Clinical Trial

— SIESTA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04723719
• Other study ID #: UZ Leuven
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Adolescents
• CBT
• Sleep

Intervention

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:
• Treatment as usual for ADHD
Participants continue their treatment as usual for ADHD.

Locations

Country	Name	City	State
Belgium	UPC Leuven	Leuven	Vlaams Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven, Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep architecture objective TST pre-test to post-test	objective (actigraphy) sleep architecture (specified as TST in hours and minutes)	From pre-test to post-test (+- 8 weeks)
Primary	Sleep architecture objective SOL pre-test to post-test	objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)	From pre-test to post-test (+- 8 weeks)
Primary	Sleep architecture objective SE 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)
Primary	Sleep architecture objective NoA pre-test to post-test	objective (actigraphy) sleep architecture (specified as NoA)	From pre-test to post-test (+- 8 weeks)
Primary	Sleep architecture subjective TST 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)
Primary	Sleep architecture subjective SOL 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)
Primary	Sleep architecture subjective SE 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)
Primary	Sleep architecture subjective NoA pre-test to post-test	subjective (sleep logs) sleep architecture (specified as NoA)	From pre-test to post-test (+- 8 weeks)
Primary	Sleep architecture objective TST 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)
Primary	Sleep architecture objective SOL 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)
Primary	Sleep architecture objective SE 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)
Primary	Sleep architecture objective NoA pre-test to follow-up	objective (actigraphy) sleep architecture (specified as NoA)	From pre-test to follow-up (+-3 months after posttest)
Primary	Sleep architecture subjective TST 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)
Primary	Sleep architecture subjective SOL 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)
Primary	Sleep architecture subjective SE 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)
Primary	Sleep architecture subjective NoA pre-test to follow-up	subjective (sleep logs) sleep architecture (specified as NoA)	From pre-test to follow-up (+-3 months after posttest)
Primary	Sleep problems SSHS pre-test to post-test	subjective sleep problems assessed by questionnaires (SSHS)	From pre-test to post-test (+- 8 weeks)
Primary	Sleep problems CSRQ pre-test to post-test	subjective sleep problems assessed by questionnaires (CSRQ)	From pre-test to post-test (+- 8 weeks)
Primary	Sleep problems CSHQ pre-test to post-test	subjective sleep problems assessed by questionnaires (CSHQ)	From pre-test to post-test (+- 8 weeks)
Primary	Sleep problems SSHS pre-test to follow-up	subjective sleep problems assessed by questionnaires (SSHS)	From pre-test to follow-up (+-3 months after posttest)
Primary	Sleep problems CSRQ pre-test to follow-up	subjective sleep problems assessed by questionnaires (CSRQ)	From pre-test to follow-up (+-3 months after posttest)
Primary	Sleep problems CSHQ pre-test to follow-up	subjective sleep problems assessed by questionnaires (CSHQ)	From pre-test to follow-up (+-3 months after posttest)
Primary	Sleep hygiene pre-test to post-test	subjective sleep hygiene assessed by questionnaires (ASHSr)	From pre-test to post-test (+- 8 weeks)
Primary	Sleep hygiene pre-test to follow-up	subjective sleep hygiene assessed by questionnaires (ASHSr)	From pre-test to follow-up (+-3 months after posttest)
Secondary	ADHD symptoms pre-test to post-test	Assessed by parents (DBDRS)	From pre-test to post-test (+- 8 weeks)
Secondary	ADHD symptoms pre-test to follow-up	Assessed by parents (DBDRS)	From pre-test to follow-up (+-3 months after posttest)
Secondary	Parent-adolescent conflict pre-test to post-test	Assessed by parents (CBQ)	From pre-test to post-test (+- 8 weeks)
Secondary	Parent-adolescent conflict pre-test to follow-up	Assessed by parents (CBQ)	From pre-test to follow-up (+-3 months after posttest)
Secondary	Homework problems pre-test to post-test	Assessed by parents (HPC)	From pre-test to post-test (+- 8 weeks)
Secondary	Academic competence pre-test to post-test	Assessed by teacher (CPS)	From pre-test to post-test (+- 8 weeks)
Secondary	Homework problems pre-test to follow-up	Assessed by parents (HPC)	From pre-test to follow-up (+-3 months after posttest)
Secondary	Academic competence pre-test to follow-up	Assessed by teacher (CPS)	From pre-test to follow-up (+-3 months after posttest)
Secondary	Comorbidities: oppositional-defiant disorder pre-test to post-test	Assessed by parents (DBDRS)	From pre-test to post-test (+- 8 weeks)
Secondary	Comorbidities: anxiety pre-test to post-test	Assessed by adolescent (SCARED-R)	From pre-test to post-test (+- 8 weeks)
Secondary	Comorbidities: depression pre-test to post-test	Assessed by adolescent (CDI-2)	From pre-test to post-test (+- 8 weeks)
Secondary	Comorbidities: oppositional-defiant disorder pre-test to follow-up	Assessed by parents (DBDRS)	From pre-test to follow-up (+-3 months after posttest)
Secondary	Comorbidities: anxiety pre-test to follow-up	Assessed by adolescent (SCARED-R)	From pre-test to follow-up (+-3 months after posttest)
Secondary	Comorbidities: depression pre-test to follow-up	Assessed by adolescent (CDI-2)	From pre-test to follow-up (+-3 months after posttest)