SIESTA Sleep IntervEntion as Symptom Treatment for ADHD - Blended CBT Sleep Intervention to Improve Sleep, ADHD Symptoms and Related Problems in Adolescents With ADHD
概览
- 阶段
- 不适用
- 干预措施
- SIESTA
- 疾病 / 适应症
- ADHD
- 发起方
- Universitaire Ziekenhuizen KU Leuven
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Saskia Van der Oord
Prof. Dr.
KU Leuven
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SIESTA training + treatment as usual for ADHD
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).
干预措施: SIESTA
SIESTA training + treatment as usual for ADHD
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).
干预措施: Treatment as usual for ADHD
Treatment as usual for ADHD only
Participants continue their treatment as usual for ADHD (mostly ADHD-medication).
干预措施: Treatment as usual for ADHD
结局指标
主要结局
Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Post-test
时间窗: From pre-test to post-test (+- 8 weeks)
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Post-test
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From pre-test to follow-up (+-3 months after posttest)
objective (actigraphy) sleep architecture (specified as NoA: Number of Awakenings)
Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test
时间窗: From pre-test to post-test (+/-8 weeks)
objective (actigraphy) sleep architecture (specified as TST in hours and minutes)
Sleep Architecture Objective SOL [Sleep Onset Latency] Pre-test to Post-test
时间窗: 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
时间窗: 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
时间窗: From pre-test to post-test (+- 8 weeks)
Sleep architecture objective (actigraphy) sleep architecture (specified as Number of Awakenings)
Sleep Architecture Subjective SOL [Sleep Onset Latency] Pre-test to Follow-up
时间窗: 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
时间窗: 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
时间窗: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as NoA: Number of Awakenings)
Sleep Architecture Subjective TST [Total Sleep Time] Pre-test to Follow-up
时间窗: From pre-test to follow-up (+-3 months after posttest)
subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)
Sleep Problems SSHS [School Sleep Habits Survey] [ Pre-test to Post-test
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Post-test(From pre-test to post-test (+- 8 weeks))
- DBDRS [Disruptive Behavior Disorders Rating Scale] ADHD Symptoms Pre-test to Follow-up(From pre-test to follow-up (+-3 months after posttest))
- CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Post-test(From pre-test to post-test (+- 8 weeks))
- CBQ [Conflict Behavior Questionnaire] Parent-adolescent Conflict Pre-test to Follow-up(From pre-test to follow-up (+-3 months after posttest))
- HPC [Homework Problems Checklist] Homework Problems Pre-test to Post-test(From pre-test to post-test (+- 8 weeks))
- CPS [Classroom Performance Scale] Academic Competence Pre-test to Post-test(From pre-test to post-test (+- 8 weeks))
- HPC [Homework Problems Checklist] Homework Problems Pre-test to Follow-up(From pre-test to follow-up (+-3 months after posttest))
- CPS [Classroom Performance Scale] Academic Competence Pre-test to Follow-up(From pre-test to follow-up (+-3 months after posttest))
- DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Post-test(From pre-test to post-test (+- 8 weeks))
- SCARED-R [Screen for Child Anxiety Related Emotional Disorders Comorbidities] Anxiety Pre-test to Post-test(From pre-test to post-test (+- 8 weeks))
- CDI [Children's Depression Inventory] Depression Pre-test to Post-test(From pre-test to post-test (+- 8 weeks))
- DBDRS [Disruptive Behavior Disorders Rating Scale] Oppositional-defiant Disorder Pre-test to Follow-up(From pre-test to follow-up (+-3 months after posttest))
- 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))
- CDI [Children's Depression Inventory] Depression Pre-test to Follow-up(From pre-test to follow-up (+-3 months after posttest))