Back to resultsSleep IntervEntion as Symptom Treatment for ADHD (SIESTA)
Primary Purpose
ADHD, Sleep, Adolescents
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SIESTA
Treatment as usual for ADHD
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- UPC Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SIESTA training + treatment as usual for ADHD
Treatment as usual for ADHD only
Arm Description
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).
Participants continue their treatment as usual for ADHD (mostly ADHD-medication).
Outcomes
Primary Outcome Measures
Sleep architecture objective TST pre-test to post-test
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
Sleep architecture objective SOL pre-test to post-test
objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)
Sleep architecture objective SE pre-test to post-test
objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)
Sleep architecture objective NoA pre-test to post-test
objective (actigraphy) sleep architecture (specified as NoA)
Sleep architecture subjective TST pre-test to post-test
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
Sleep architecture subjective SOL pre-test to post-test
subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)
Sleep architecture subjective SE pre-test to post-test
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)
Sleep architecture subjective NoA pre-test to post-test
subjective (sleep logs) sleep architecture (specified as NoA)
Sleep architecture objective TST pre-test to follow-up
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
Sleep architecture objective SOL pre-test to follow-up
objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)
Sleep architecture objective SE pre-test to follow-up
objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)
Sleep architecture objective NoA pre-test to follow-up
objective (actigraphy) sleep architecture (specified as NoA)
Sleep architecture subjective TST pre-test to follow-up
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
Sleep architecture subjective SOL pre-test to follow-up
subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)
Sleep architecture subjective SE pre-test to follow-up
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)
Sleep architecture subjective NoA pre-test to follow-up
subjective (sleep logs) sleep architecture (specified as NoA)
Sleep problems SSHS pre-test to post-test
subjective sleep problems assessed by questionnaires (SSHS)
Sleep problems CSRQ pre-test to post-test
subjective sleep problems assessed by questionnaires (CSRQ)
Sleep problems CSHQ pre-test to post-test
subjective sleep problems assessed by questionnaires (CSHQ)
Sleep problems SSHS pre-test to follow-up
subjective sleep problems assessed by questionnaires (SSHS)
Sleep problems CSRQ pre-test to follow-up
subjective sleep problems assessed by questionnaires (CSRQ)
Sleep problems CSHQ pre-test to follow-up
subjective sleep problems assessed by questionnaires (CSHQ)
Sleep hygiene pre-test to post-test
subjective sleep hygiene assessed by questionnaires (ASHSr)
Sleep hygiene pre-test to follow-up
subjective sleep hygiene assessed by questionnaires (ASHSr)
Secondary Outcome Measures
ADHD symptoms pre-test to post-test
Assessed by parents (DBDRS)
ADHD symptoms pre-test to follow-up
Assessed by parents (DBDRS)
Parent-adolescent conflict pre-test to post-test
Assessed by parents (CBQ)
Parent-adolescent conflict pre-test to follow-up
Assessed by parents (CBQ)
Homework problems pre-test to post-test
Assessed by parents (HPC)
Academic competence pre-test to post-test
Assessed by teacher (CPS)
Homework problems pre-test to follow-up
Assessed by parents (HPC)
Academic competence pre-test to follow-up
Assessed by teacher (CPS)
Comorbidities: oppositional-defiant disorder pre-test to post-test
Assessed by parents (DBDRS)
Comorbidities: anxiety pre-test to post-test
Assessed by adolescent (SCARED-R)
Comorbidities: depression pre-test to post-test
Assessed by adolescent (CDI-2)
Comorbidities: oppositional-defiant disorder pre-test to follow-up
Assessed by parents (DBDRS)
Comorbidities: anxiety pre-test to follow-up
Assessed by adolescent (SCARED-R)
Comorbidities: depression pre-test to follow-up
Assessed by adolescent (CDI-2)
Full Information
NCT ID
NCT04723719
First Posted
January 12, 2021
Last Updated
May 4, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Research Foundation Flanders, KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04723719
Brief Title
Sleep IntervEntion as Symptom Treatment for ADHD
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Research Foundation Flanders, KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Sleep, Adolescents, CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial with training group and control group.
Masking
Investigator
Masking Description
Stratified permuted block randomization, controlling for ADHD medication use (yes/no), is done by a masked/independent researcher.
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SIESTA training + treatment as usual for ADHD
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment as usual for ADHD only
Arm Type
Active Comparator
Arm Description
Participants continue their treatment as usual for ADHD (mostly ADHD-medication).
Intervention Type
Behavioral
Intervention Name(s)
SIESTA
Other Intervention Name(s)
Sleep IntervEntion as Symptom Treatment for ADHD
Intervention Description
SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.
Intervention Type
Other
Intervention Name(s)
Treatment as usual for ADHD
Other Intervention Name(s)
TAU
Intervention Description
Participants continue their treatment as usual for ADHD.
Primary Outcome Measure Information:
Title
Sleep architecture objective TST pre-test to post-test
Description
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep architecture objective SOL pre-test to post-test
Description
objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep architecture objective SE pre-test to post-test
Description
objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep architecture objective NoA pre-test to post-test
Description
objective (actigraphy) sleep architecture (specified as NoA)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep architecture subjective TST pre-test to post-test
Description
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep architecture subjective SOL pre-test to post-test
Description
subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep architecture subjective SE pre-test to post-test
Description
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep architecture subjective NoA pre-test to post-test
Description
subjective (sleep logs) sleep architecture (specified as NoA)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep architecture objective TST pre-test to follow-up
Description
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep architecture objective SOL pre-test to follow-up
Description
objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep architecture objective SE pre-test to follow-up
Description
objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep architecture objective NoA pre-test to follow-up
Description
objective (actigraphy) sleep architecture (specified as NoA)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep architecture subjective TST pre-test to follow-up
Description
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep architecture subjective SOL pre-test to follow-up
Description
subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep architecture subjective SE pre-test to follow-up
Description
subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep architecture subjective NoA pre-test to follow-up
Description
subjective (sleep logs) sleep architecture (specified as NoA)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep problems SSHS pre-test to post-test
Description
subjective sleep problems assessed by questionnaires (SSHS)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep problems CSRQ pre-test to post-test
Description
subjective sleep problems assessed by questionnaires (CSRQ)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep problems CSHQ pre-test to post-test
Description
subjective sleep problems assessed by questionnaires (CSHQ)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep problems SSHS pre-test to follow-up
Description
subjective sleep problems assessed by questionnaires (SSHS)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep problems CSRQ pre-test to follow-up
Description
subjective sleep problems assessed by questionnaires (CSRQ)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep problems CSHQ pre-test to follow-up
Description
subjective sleep problems assessed by questionnaires (CSHQ)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Sleep hygiene pre-test to post-test
Description
subjective sleep hygiene assessed by questionnaires (ASHSr)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Sleep hygiene pre-test to follow-up
Description
subjective sleep hygiene assessed by questionnaires (ASHSr)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Secondary Outcome Measure Information:
Title
ADHD symptoms pre-test to post-test
Description
Assessed by parents (DBDRS)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
ADHD symptoms pre-test to follow-up
Description
Assessed by parents (DBDRS)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Parent-adolescent conflict pre-test to post-test
Description
Assessed by parents (CBQ)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Parent-adolescent conflict pre-test to follow-up
Description
Assessed by parents (CBQ)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Homework problems pre-test to post-test
Description
Assessed by parents (HPC)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Academic competence pre-test to post-test
Description
Assessed by teacher (CPS)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Homework problems pre-test to follow-up
Description
Assessed by parents (HPC)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Academic competence pre-test to follow-up
Description
Assessed by teacher (CPS)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Comorbidities: oppositional-defiant disorder pre-test to post-test
Description
Assessed by parents (DBDRS)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Comorbidities: anxiety pre-test to post-test
Description
Assessed by adolescent (SCARED-R)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Comorbidities: depression pre-test to post-test
Description
Assessed by adolescent (CDI-2)
Time Frame
From pre-test to post-test (+- 8 weeks)
Title
Comorbidities: oppositional-defiant disorder pre-test to follow-up
Description
Assessed by parents (DBDRS)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Comorbidities: anxiety pre-test to follow-up
Description
Assessed by adolescent (SCARED-R)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
Title
Comorbidities: depression pre-test to follow-up
Description
Assessed by adolescent (CDI-2)
Time Frame
From pre-test to follow-up (+-3 months after posttest)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saskia Van der Oord, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPC Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
After all waves of the study are finished and data analyzed. This is expected to happen in 2024. Data will be available 25 years after the study.
Learn more about this trial
Sleep IntervEntion as Symptom Treatment for ADHD
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