Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Restriction Therapy | Experimental | Participants attend telehealth sessions once per week for three weeks and implement sleep restriction therapy in between sessions and for 4 weeks during a follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Restriction Therapy | Behavioral | Therapist led sleep restriction therapy sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability 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. | 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. | 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. | At end of treatment (approximately week 10) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma K Baker, MPsych(Clin), PhD | Contact | 6507361235 | ekbaker@stanford.edu | |
| Robin Libove, BS | Contact | 6507361235 | rlibove@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Emma K Baker, MPsych(Clin), PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35635067 | Background | Han GT, Trevisan DA, Abel EA, Cummings EM, Carlos C, Bagdasarov A, Kala S, Parker T, Canapari C, McPartland JC. Associations between sleep problems and domains relevant to daytime functioning and clinical symptomatology in autism: A meta-analysis. Autism Res. 2022 Jul;15(7):1249-1260. doi: 10.1002/aur.2758. Epub 2022 May 30. | |
| 35712855 |
Not provided
Not provided
No current plan to share data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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). | 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). | 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) | Baseline, Week 1, Week 2 |
| Cain N, Richardson C, Bartel K, Whittall H, Reeks J, Gradisar M. A randomised controlled dismantling trial of sleep restriction therapies for chronic insomnia disorder in middle childhood: effects on sleep and anxiety, and possible contraindications. J Sleep Res. 2022 Dec;31(6):e13658. doi: 10.1111/jsr.13658. Epub 2022 Jun 17. |