Sleep IntervEntion as Symptom Treatment for ADHD

Study Overview
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Brief Summary
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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.

Official Title
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SIESTA Sleep IntervEntion as Symptom Treatment for ADHD - Blended CBT Sleep Intervention to Improve Sleep, ADHD Symptoms and Related Problems in Adolescents With ADHD

Conditions
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ADHD, Sleep, Adolescents, CBT

Intervention / Treatment
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* Behavioral: SIESTA
* Other: Treatment as usual for ADHD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial with training group and control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SIESTA training + treatment as usual for ADHD<br>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). | Behavioral: SIESTA<br>* SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.<br>* Other names: Sleep IntervEntion as Symptom Treatment for ADHD;Other: Treatment as usual for ADHD<br>* Participants continue their treatment as usual for ADHD.<br>* Other names: TAU;|
| Active Comparator: Treatment as usual for ADHD only<br>Participants continue their treatment as usual for ADHD (mostly ADHD-medication). | Other: Treatment as usual for ADHD<br>* Participants continue their treatment as usual for ADHD.<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| Sleep architecture objective NoA pre-test to post-test | objective (actigraphy) sleep architecture (specified as NoA) | From pre-test to post-test (+- 8 weeks) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| Sleep problems SSHS pre-test to post-test | subjective sleep problems assessed by questionnaires (SSHS) | From pre-test to post-test (+- 8 weeks) | 
| Sleep problems CSRQ pre-test to post-test | subjective sleep problems assessed by questionnaires (CSRQ) | From pre-test to post-test (+- 8 weeks) | 
| Sleep problems CSHQ pre-test to post-test | subjective sleep problems assessed by questionnaires (CSHQ) | From pre-test to post-test (+- 8 weeks) | 
| 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) | 
| 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) | 
| 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) | 
| Sleep hygiene pre-test to post-test | subjective sleep hygiene assessed by questionnaires (ASHSr) | From pre-test to post-test (+- 8 weeks) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD symptoms pre-test to post-test | Assessed by parents (DBDRS) | From pre-test to post-test (+- 8 weeks) | 
| ADHD symptoms pre-test to follow-up | Assessed by parents (DBDRS) | From pre-test to follow-up (+-3 months after posttest) | 
| Parent-adolescent conflict pre-test to post-test | Assessed by parents (CBQ) | From pre-test to post-test (+- 8 weeks) | 
| Parent-adolescent conflict pre-test to follow-up | Assessed by parents (CBQ) | From pre-test to follow-up (+-3 months after posttest) | 
| Homework problems pre-test to post-test | Assessed by parents (HPC) | From pre-test to post-test (+- 8 weeks) | 
| Academic competence pre-test to post-test | Assessed by teacher (CPS) | From pre-test to post-test (+- 8 weeks) | 
| Homework problems pre-test to follow-up | Assessed by parents (HPC) | From pre-test to follow-up (+-3 months after posttest) | 
| Academic competence pre-test to follow-up | Assessed by teacher (CPS) | From pre-test to follow-up (+-3 months after posttest) | 
| Comorbidities: oppositional-defiant disorder pre-test to post-test | Assessed by parents (DBDRS) | From pre-test to post-test (+- 8 weeks) | 
| Comorbidities: anxiety pre-test to post-test | Assessed by adolescent (SCARED-R) | From pre-test to post-test (+- 8 weeks) | 
| Comorbidities: depression pre-test to post-test | Assessed by adolescent (CDI-2) | From pre-test to post-test (+- 8 weeks) | 
| Comorbidities: oppositional-defiant disorder pre-test to follow-up | Assessed by parents (DBDRS) | From pre-test to follow-up (+-3 months after posttest) | 
| Comorbidities: anxiety pre-test to follow-up | Assessed by adolescent (SCARED-R) | From pre-test to follow-up (+-3 months after posttest) | 
| Comorbidities: depression pre-test to follow-up | Assessed by adolescent (CDI-2) | From pre-test to follow-up (+-3 months after posttest) |