The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Therapist led sleep restriction therapy sessions.
Stanford University
Stanford, California, United States
RECRUITINGAcceptability of Sleep Restriction Therapy
Acceptability will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least acceptable and 5 being the most acceptable.
Time frame: At end of treatment (approximately week 10)
Tolerability of Sleep Restriction Therapy
Tolerability will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least tolerable and 5 being the most tolerable.
Time frame: At end of treatment (approximately week 10)
Feasibility of Sleep Restriction Therapy
Feasibility will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least feasible and 5 being the most feasible.
Time frame: At end of treatment (approximately week 10)
Change from baseline on the Sleep Disturbance Scale for Children
The Sleep Disturbance Scale for Children (SDSC) evaluates various sleep disorders including difficulties in falling asleep and staying asleep, sleep-disordered breathing, arousal disorders, sleep-wake transition disorders, excessive sleepiness, and excessive sweating during sleep. Scores range from 26 to 130. Higher scores on the SDSC are indicative of greater sleep disturbance. This outcome measure will determine the effectiveness of sleep restriction therapy in improving sleep disturbances in children with autism spectrum disorder.
Time frame: Screening, Baseline, End of Week 2 Treatment, End of Treatment (approximately week 10)
Change in sleep onset latency (Sleep-Wake Diary)
This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average sleep onset latency will be calculated from the diary for the purposes of this study.
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Time frame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
Change in sleep efficiency (Sleep-Wake Diary)
This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average sleep efficiency will be calculated from the diary for the purposes of this study.
Time frame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
Change in wake after sleep onset duration (Sleep-Wake Diary)
This study utilizes a brief sleep-wake diary to collect parent-reported sleep variables (e.g., what time did your child try to sleep last night). Average wake after sleep onset will be calculated from the diary for the purposes of this study.
Time frame: Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10)
Change in sleep onset latency (Actigraphy)
Children wear an actigraphy monitor for the purposes of collecting objective information about sleep onset latency (time taken to fall asleep).
Time frame: Baseline, Week 1, Week 2
Change in sleep efficiency (Actigraphy)
Children wear an actigraphy monitor for the purposes of collecting objective information about sleep efficiency (percentage of time in bed that the child is actually asleep).
Time frame: Baseline, Week 1, Week 2
Change in Wake After Sleep Onset (Actigraphy)
Children wear an actigraphy monitor for the purposes of collecting objective information about wake after sleep onset duration (the amount of time spent awake after falling asleep)
Time frame: Baseline, Week 1, Week 2