Sleep IntervEntion as Symptom Treatment for ADHD

NCT ID: NCT04723719

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2024-02-01

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.

Conditions

ADHD; Sleep; Adolescents; CBT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

SIESTA

Intervention Type: BEHAVIORAL

SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.

Treatment as usual for ADHD

Intervention Type: OTHER

Participants continue their treatment as usual for ADHD.

Treatment as usual for ADHD only

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

Group Type: ACTIVE_COMPARATOR

Treatment as usual for ADHD

Intervention Type: OTHER

Participants continue their treatment as usual for ADHD.

Interventions

SIESTA

SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.

Intervention Type: BEHAVIORAL

Treatment as usual for ADHD

Participants continue their treatment as usual for ADHD.

Intervention Type: OTHER

Other Intervention Names

Sleep IntervEntion as Symptom Treatment for ADHD; TAU

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Saskia Van der Oord

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saskia Van der Oord, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

UPC Leuven

Leuven, Vlaams Brabant, Belgium

Countries

Belgium

References

Keuppens L, Marten F, Baeyens D, Boyer B, Danckaerts M, van der Oord S. Sleep IntervEntion as Symptom Treatment for ADHD (SIESTA)-Blended CBT sleep intervention to improve sleep, ADHD symptoms and related problems in adolescents with ADHD: Protocol for a randomised controlled trial. BMJ Open. 2023 Apr 13;13(4):e065355. doi: 10.1136/bmjopen-2022-065355.

Reference Type: DERIVED

PMID: 37055205 (View on PubMed)

Other Identifiers

UZ Leuven

Identifier Type: -

Identifier Source: org_study_id