Sleep in Children With Autism and Intellectual Disability
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorVärmland County Council, Sweden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Insomnia AND
Autism AND
Intellectual Disability.
Disqualifiers
Started puberty OR
Epilepsy OR
Ongoing melatonin treatment OR
Obstructive sleep apnea
Trial design
Design model
Single group
Treatments tested in this trial
Applied Behavior Analysis
BehavioralApplied 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Single case experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total Sleep Time
Change from baseline to follow up regarding Total Sleep Time (TST), based on actigraphy.
Time frame
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
Time frame
One week after completed intervention,3
Night time awakenings
Change from baseline to follow up regarding Night time awakenings based on actigraphy
Time frame
One week after completed intervention,Secondary outcomes
1
Sleep diary measures of Total Sleep Time
Change from baseline to follow up regarding Total Sleep Time (TST), based on sleep diaries.
Time frame
One week after completed intervention2
Sleep diary measures of Wakefulness After Sleep Onset
Change from baseline to follow up regarding Wakefulness After Sleep Onset (WASO) based on sleep diary
Time frame
One week after completed intervention3
Sleep diary measures of Night time awakenings
Change from baseline to follow up regarding nighttime awakenings based on sleep diary
Time frame
One week after completed interventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Värmland County Council, Sweden
Lead sponsor
Uppsala University
Collaborator
Uppsala County Council, Sweden
Collaborator
Source ClinicalTrials.gov
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