None listed
Conditions
Brief summary
Autism is a lifelong neurodevelopmental disorder characterised by differences in social communication, repetitive and restricted behaviours and sensitivities to sensory input (Diagnostic and Statistical Manual of Mental Disorders 5th ed: DSM-5; APA, 2013). Along with autism symptomology, autism is linked to a greater incidence of insomnia, with the prevalence estimated at 60- 86% in school aged children, compared to 5-30% among their non-autistic peers (Paine & Gradisar, 2011; Papadopoulos et al., 2019; Liu et al., 2006). Consequences of poor sleep include behavioural problems, impaired adaptive behaviour, psychopathology and exacerbated autism symptomology (Paine & Gradisar, 2011; Papadopoulos et al., 2019). Resultingly, effective treatment for insomnia is imperative in order to reduce negative consequences. Cognitive Behavioural Therapy for insomnia (CBTi) is recommended as a primary treatment for insomnia (American Academy of Sleep, 2005) and has demonstrated efficacious outcomes (Quaseem et al., 2016). However, there is scant research on CBTi as a treatment for insomnia among individuals with autism, with the majority of studies focusing on pharmaceutical options (Cortesi et al., 2012). Therefore, the present study aims to establish the efficacy of Cognitive Behaviour Therapy for Insomnia (CBTi) in children aged 7-12 with autism, compared to a waitlist control group of children aged 7-12 with autism. Hypotheses Children who receive CBTi will have significantly greater improvements in sleep parameters including sleep onset latency, wake after sleep onset, sleep duration and sleep efficiency compared to a waitlist controlled autistic group. Additionally, children who receive CBTi will have significantly greater improvements in anxiety, depression and daytime sleepiness compared to the waitlist controlled autistic group.
Interventions
Following enrollment in the study, participants will be randomly allocated to either the CBTi or a waitlist control group. Random allocation to condition will be achieved using a computer-generated permuted block schedule. This computerised randomised scheduling will ensure even numbers of participants across the two groups, and ensures the researchers are blind to treatment allocation as this occurs before participants enter the study). All eligible families will be provided with the materials
Following enrollment in the study, participants will be randomly allocated to either the CBTi or a waitlist control group. Random allocation to condition will be achieved using a computer-generated permuted block schedule. This computerised randomised scheduling will ensure even numbers of participants across the two groups, and ensures the researchers are blind to treatment allocation as this occurs before participants enter the study). All eligible families will be provided with the materials for their baseline week, including a sleep diary and questionnaires. CBTi will be delivered by a registered or provisional psychologist and will include three manualised 1-hour therapy sessions, based on readily available clinical resources, which will be conducted via telehealth. Sessions will occur once per week on a set day. These sessions will address: (1) sleep education (children’s sleep needs, the stages of sleep, sleep homeostasis) and sleep hygiene (practices and habits that support good sleep, such as a bedtime routine, avoiding caffeine and stimulants, and having a quiet and dark bedroom environment) (Paine & Gradisar, 2011); (2) sleep restriction therapy (restricting time in bed to baseline total nightly sleep duration for one week by shifting bedtimes later) (Spielman, Yang & Glovinsky, 2011); (3) graduated exposure (Rapee, Wignall, Hudson, & Schniering, 2000) to night-time separation from parent (including rewards for successful achievements and practice) and relaxation and coping self-talk. Therapists will use a checklist to indicate attendance and topics covered for each session, which will be reviewed by the chief investigator. The sleep diary is a readily available resource (Carney et al., 2012). The sleep diary is a daily log of the sleep of the participant, including information about bedtime, sleep onset latency, wake after sleep onset and sleep duration. The sleep diary takes less than 5 minutes to complete each day. The one-week sleep diary will be used at baseline, each week following the treatment sessions, at post-intervention and at one-month follow up. Wrist actigraphy will not be used in this study.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnoses of autism and insomnia. The inclusion criteria for families is that one parent/care-giver has basic written and spoken English
Exclusion criteria
Intellectual disability for the child. If the parent of care-giver does not have spoken and written English proficiency to the level that they are able to complete study measures and support the child during therapy sessions.
Outcome results
None listed