ADHD, Adolescents, CBT, Sleep
Conditions
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 3-4 months follow-up effectiveness of the blended cognitive behavioral sleep intervention in adolescents with ADHD.
Detailed description
To test effectiveness a randomized controlled trial in conducted in which adolescents with ADHD and sleep problems are randomized to either their Treatment as Usual for ADHD or their Treatment as usual for ADHD combined with the SIESTA cognitive behavioral sleep interventions. Effects on sleep, ADHD behavior and co-occuring problems are assessed at pretest, post test and at 3-4 months follow-up.
Interventions
BEHAVIORALSIESTA
SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.
Participants continue their treatment as usual for ADHD.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Research Foundation Flanders
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Stratified permuted block randomization, controlling for ADHD medication use (yes/no), is done by a masked/independent researcher.
Intervention model description
Randomized Controlled Trial with training group and control group.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | subjective (sleep logs) sleep architecture (specified as TST in hours and minutes) |
| Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | objective (actigraphy) sleep architecture (specified as SOL in hours and minutes) |
| Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage) |
| Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | Sleep architecture objective (actigraphy) sleep architecture (specified as Number of Awakenings) |
| Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test | From pre-test to post-test (+/-8 weeks) | objective (actigraphy) sleep architecture (specified as TST in hours and minutes) |
| Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes) |
| Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage) |
| Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings) |
| Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | objective (actigraphy) sleep architecture (specified as TST in hours and minutes) |
| Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | objective (actigraphy) sleep architecture (specified as SOL in hours and minutes) |
| Sleep Architecture Objective SE [Sleep Efficiency] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage) |
| Sleep Architecture Objective NoA [Number of Awakenings] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | objective (actigraphy) sleep architecture (specified as NoA: Number of Awakenings) |
| Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | subjective (sleep logs) sleep architecture (specified as TST in hours and minutes) |
| Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes) |
| Sleep Architecture Subjective SE [Sleep Efficiency] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage) |
| Sleep Architecture Subjective NoA [Number of Awakenings] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings) |
| Sleep Problems SSHS [School Sleep Habits Survey] [ Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | subjective sleep problems assessed by questionnaires (SSHS) School Sleep Habits Survey: questions are scored on a 5-point Likert scale, with higher scores indicating a worse outcome, minimum 10 - maximum 50 |
| Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | subjective sleep problems assessed by questionnaires (CSRQ) Chronic Sleep Reduction Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 20 - maximum 60 |
| Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | subjective sleep problems assessed by questionnaires (CSHQ) Children Sleep Habits Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 33 - maximum 99 |
| Sleep Problems SSHS [School Sleep Habits Survey] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | subjective sleep problems assessed by questionnaires (SSHS) School Sleep Habits Survey: questions are scored on a 5-point Likert scale, with higher scores indicating a worse outcome, minimum 10 - maximum 50 |
| Sleep Problems CSRQ [Chronic Sleep Reduction Questionnaire] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | subjective sleep problems assessed by questionnaires (CSRQ) Chronic Sleep Reduction Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 20 - maximum 60 |
| Sleep Problems CSHQ [Children Sleep Habits Questionnaire] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | subjective sleep problems assessed by questionnaires (CSHQ) Children Sleep Habits Questionnaire: questions are scored on a 3-point Likert scale, with higher scores indicating a worse outcome, minimum 33 - maximum 99 |
| ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | subjective sleep hygiene assessed by questionnaires (ASHSr) Revised Adolescent Sleep Hygiene Scale: questions are scored on a 6-point Likert scale, with higher scores indicating a better outcome, minimum 1 - maximum 6 |
| ASHSr [Revised Adolescent Sleep Hygiene Scale] Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | subjective sleep hygiene assessed by questionnaires (ASHSr) Revised Adolescent Sleep Hygiene Scale: questions are scored on a 6-point Likert scale, with higher scores indicating a better outcome, minimum 1 - maximum 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: questions are scored on a 4-point Likert scale, with higher scores indicating a worse outcome, minimum 0 - maximum 54 |
| DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: questions are scored on a 4-point Likert scale, with higher scores indicating a worse outcome, minimum 0 - maximum 54 |
| CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome |
| CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | Assessed by parents (CBQ) Conflict Behavior Questionnaire: rated true-false, minimum 0 - maximum 20, higher scores indicate worse outcome |
| HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | Assessed by parents (HPC) : rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome |
| CPS [Classroom Performance Scale] Academic Competence Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome |
| HPC [Homework Problems Checklist] Homework Problems Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | Assessed by parents (HPC) Homework Problems Checklist: rated on a 4-point Likert scale, minimum 0 - maximum 60, higher scores indicate worse outcome |
| CPS [Classroom Performance Scale] Academic Competence Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | Assessed by teacher (CPS) Classroom Performance Scale: rated on a 5-point Likert scale, minimum 13 - maximum 65, higher scores indicate worse outcome |
| DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: rated on a 4-point Likert scale, minimum 0 - maximum 24, higher scores mean worse outcome |
| SCARED-R [Screen for Child Anxiety Related Emotional Disorders Comorbidities] Anxiety Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | Assessed by adolescent (SCARED-R) Screen for Child Anxiety Related Emotional Disorders: rated on a 3-point Likert scale, minimum 0 - maximum 82, higher scores indicate worse outcome |
| CDI [Children's Depression Inventory] Depression Pre-test to Post-test | From pre-test to post-test (+- 8 weeks) | Assessed by adolescent (CDI-2) Children's Depression Inventory, Second Edition: rated on a 3-point Likert scale, minimum 0 - maximum 56, higher scores indicate worse outcome |
| DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | Assessed by parents (DBDRS) Disruptive Behavior Disorders Rating Scale: rated on a 4-point Likert scale, minimum 0 - maximum 24, higher scores mean worse outcome |
| SCARED-R [Screen for Child Anxiety Related Emotional Disorders] Anxiety Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | Assessed by adolescent (SCARED-R) Screen for Child Anxiety Related Emotional Disorders: rated on a 3-point Likert scale, minimum 0 - maximum 82, higher scores indicate worse outcome |
| CDI [Children's Depression Inventory] Depression Pre-test to Follow-up | From pre-test to follow-up (+-3 months after posttest) | Assessed by adolescent (CDI-2) Children's Depression Inventory, Second Edition: rated on a 3-point Likert scale, minimum 0 - maximum 56, higher scores indicate worse outcome |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORSaskia Van der Oord, PhD
KU Leuven
Baseline characteristics
| Characteristic | — |
|---|---|
| ADHD presentation Combined | 21 Participants |
| ADHD presentation Hyperactive-impulsive | 4 Participants |
| ADHD presentation Inattentive | 20 Participants |
| Age, Continuous | 14.36 years STANDARD_DEVIATION 1.43 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 0 |
| other Total, other adverse events | 0 / 47 | 0 / 0 |
| serious Total, serious adverse events | 1 / 47 | 0 / 0 |
Outcome results
None listed