Sleep IntervEntion as Symptom Treatment for ADHD (SIESTA)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Adolescents; CBT; ADHD; Sleep

Treatments: Other: Treatment as usual for ADHD; Behavioral: SIESTA

Study type: Interventional

Funder types: Other

Identifiers

NCT04723719

UZ Leuven (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

SIESTA training + treatment as usual for ADHD

Experimental group

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).

Treatment:

Behavioral: SIESTA

Other: Treatment as usual for ADHD

Treatment as usual for ADHD only

Active Comparator group

Description:

Participants continue their treatment as usual for ADHD (mostly ADHD-medication).

Treatment:

Other: Treatment as usual for ADHD