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InsomniaSLEEP-AID ITNCT06403969

Sleep in Children With Autism and Intellectual Disability

A study testing Applied Behavior Analysis in people with Insomnia and Autism, run by Värmland County Council, Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Purposes: Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined; To explore the diagnostic yield of polysomnography for these individuals; To examine the feasibility and treatment effect of Applied… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Insomnia, Autism, Intellectual Disability
What is being tested?
Applied Behavior Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
14 May 2024to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Insomnia AND
  • Autism AND
  • Intellectual Disability.

Who cannot join

  • Started puberty OR
  • Epilepsy OR
  • Ongoing melatonin treatment OR
  • Obstructive sleep apnea

Trial locations and contacts

No sites are listed yet.

Sverre Wikström, Assoc Prof contact

+46703456327

sverre.wikstrom@regionvarmland.se

About this study

Official title: SLEEP - in Children With Autism and Intellectual Disability: Investigation and Treatment

Purposes: Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined; To explore the diagnostic yield of polysomnography for these individuals; To examine the feasibility and treatment effect of Applied Behavior Analysis (ABA) for insomnia, focusing on sleep maintenance difficulties, in these children.

Method: Single-case experimental design with multiple baselines and with multiple participants, with a focus on feasibility. N=15 prepubertal children, aged 6-12 years, with autism and intellectual disabilities combined, and difficulties in maintaining nighttime sleep. Assessment with home polysomnography + actigraphy. Intervention with ABA, including functional analysis, measurable goals, and behavior modification based on the functional analysis. Outcome measures from actigraphy and sleep diary with multiple data points at baseline and after treatment. Feasibility is examined as adherence to assessment and treatment, as well as in a qualitative study of parental experiences.

Read the detailed description

Pilot study with a feasibility focus using a single-case experimental design, employing multiple baselines and involving multiple participants. Children aged 6-12 with autism and intellectual disabilities, along with sleep maintenance difficulties, are recruited. Following diagnostic assessment of insomnia, up to two weeks of sleep registration using sleep diaries and actigraphy is initiated. Polysomnography will be used to identify, characterize, and map out the sleep disorder. Registration is conducted at home over one night and supplemented with a home visit. If no significant physiological explanations are discovered, treatment with Applied Behavior Analysis (ABA) conducted by a psychologist is then commenced. The intervention begins with goal formulation. Subsequently, a functional analysis is carried out to analyze the underlying function of a behavior contributing to and maintaining the sleep disorder. This assessment follows the ABC model and is based on clinical interviews, observations, sleep diaries, and actigraphy. Next, a treatment plan with measurable goals and strategies to achieve them is formulated. Interventions are based on both antecedents and consequences, with a strong emphasis on positive reinforcement of favorable sleep behaviors. Overall, the intervention is individualized, and most treatment components from cognitive behavioral therapy may be relevant. Examples include education in sleep hygiene, changes in the sleep environment, and positive reinforcement of favorable behaviors. Stimulus control techniques, such as going to bed when tired and establishing good bedtime routines with visual support, are included. Sleep restriction, limiting naps, and bedtime fading are also part of the intervention. Modified extinction techniques with parental presence may be applied, especially if co-sleeping is problematic, gradually phasing out immediate parental presence in or near the bed while remaining responsive to the child's need for security, with a clear intention to cease co-sleeping. The intervention continues until treatment goals are achieved or for a maximum of eight sessions (up to 60 minutes each) spread over a maximum of eight weeks. Sleep diaries are continued daily throughout the study period, including up to two weeks after the intervention ends. Actigraphy registration is restarted one week after the intervention ends and continues for the same duration as during the baseline registration. Sleep diaries are also recorded in the same manner for a follow-up three months after the intervention ends.

Primary outcomes are change from baseline to follow up one week after completed intervention, regarding Total Sleep Time (TST), Wakefulness After Sleep Onset (WASO), and frequency of night-time awakenings, based on actigraphy. Secondary outcomes are change from baseline to follow up regarding TST, WASO, night-time awakenings and sleep efficiency, based on sleep diaries. Specified outcome is also feasibility of investigation and intervention, as below.

Feasibility of the sleep assessment, including polysomnography, is evaluated in terms of frequency and proportion of completed assessments, as well as parental acceptance of the assessment in the qualitative component below. Method adaptation needs are described. The diagnostic yield of the assessment is reported, patient by patient, and summarized with a hypothesis-generating approach. Parents' experiences of the intervention and its feasibility are qualitatively explored and described. The interview is semi-structured, conducted one month after the intervention ends, and analyzed using qualitative content analysis. Feasibility of the ABA intervention is also evaluated in terms of frequency of completed treatments, therapist ratings of families' adherence to treatment, intervention duration, and therapists' adherence to the study protocol.

Being tested
Applied Behavior Analysis
Keywords
applied behavior analysis, polysomnography, insomnia, autism
Medical subject headings
Sleep Initiation and Maintenance Disorders, Autistic Disorder, Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Applied Behavior AnalysisBehavioural

    Applied Behavior Analysis focusing on nocturnal awakenings. It starts with identification of target behaviors and goals. A functional analysis is conducted to analyze the underlying function of a behavior in connection to the problem. A treatment plan is formulated, including strategies to achieve the goals, and methods to evaluate. Families receive education sleep hygiene. Adaptations focus on antecedents and consequences, with an emphasis on positive reinforcement of favorable behaviors. Various components of Cognitive Behavioral Therapy may be applicable. These include changes in sleep environment, stimulus control, bedtime routines with visual support and prompting. Sleep restriction and bedtime fading are included. Modified extinction techniques with parental presence can be applied, gradually phasing out parental immediate presence. The intervention continues until goals are achieved or for a maximum of 8 sessions (each lasting up to 60 minutes) spread over 8 weeks.

Study groups in NCT06403969
Study groupRoleWhat they receive
Single case experimental armExperimentalABA intervention with multiple baselines and follow up measurements
Receives: Behavioral: Applied Behavior Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Sleep Time

    Change from baseline to follow up regarding Total Sleep Time (TST), based on actigraphy.

    Measured: One week after completed intervention,

  2. Wakefulness After Sleep Onset

    Change from baseline to follow up regarding Wakefulness After Sleep Onset (WASO) based on actigraphy

    Measured: One week after completed intervention,

  3. Night time awakenings

    Change from baseline to follow up regarding Night time awakenings based on actigraphy

    Measured: One week after completed intervention,

Secondary outcomes (3)
  1. Sleep diary measures of Total Sleep Time

    Change from baseline to follow up regarding Total Sleep Time (TST), based on sleep diaries.

    Measured: One week after completed intervention

  2. Sleep diary measures of Wakefulness After Sleep Onset

    Change from baseline to follow up regarding Wakefulness After Sleep Onset (WASO) based on sleep diary

    Measured: One week after completed intervention

  3. Sleep diary measures of Night time awakenings

    Change from baseline to follow up regarding nighttime awakenings based on sleep diary

    Measured: One week after completed intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start14 May 2024 (estimated)
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Case Experimental Design
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06403969
Sponsor's protocol ID
281174
Acronym
SLEEP-AID IT
Status last verified
May 2024
First submitted
10 Apr 2024
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Applied Behavior Analysis in people with Insomnia and Autism, run by Värmland County Council, Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sverre Wikström, Assoc Prof (+46703456327, sverre.wikstrom@regionvarmland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Sleep Time (time frame: One week after completed intervention,). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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