Sleep in Children With Autism and Intellectual Disability

NCT06403969 | Not Yet Recruiting

• 1 other identifier: 281174
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Insomnia; Autism; Intellectual Disability

Keywords

applied behavior analysis; polysomnography; insomnia; autism

Outcome Measures

Primary Outcomes (3)

• Total Sleep Time

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

  One week after completed intervention,

• Wakefulness After Sleep Onset

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

  One week after completed intervention,

• Night time awakenings

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

  One week after completed intervention,

Secondary Outcomes (3)

• Sleep diary measures of Total Sleep Time

  One week after completed intervention

• Sleep diary measures of Wakefulness After Sleep Onset

  One week after completed intervention

• Sleep diary measures of Night time awakenings

  One week after completed intervention

Study Arms (1)

Single case experimental arm

EXPERIMENTAL

ABA intervention with multiple baselines and follow up measurements

Behavioral: Applied Behavior Analysis

Interventions

Applied Behavior Analysis BEHAVIORAL

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.

Single case experimental arm

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Insomnia AND
• Autism AND
• Intellectual Disability.

You may not qualify if:

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

Sponsors & Collaborators

• Värmland County Council, Sweden: lead
• Uppsala University: collaborator
• Uppsala County Council, Sweden: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Autistic Disorder; Intellectual Disability

Interventions

Applied Behavior Analysis

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sverre Wikström

  Region Värmland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sverre Wikström, Assoc Prof

CONTACT

+46703456327; sverre.wikstrom@regionvarmland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single Case Experimental Design

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 8, 2024
• Study Start: May 14, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share