Trial results for the SweetDreams Sleep Study, investigating an online behavioral sleep intervention for children with Autism Spectrum Disorder and Insomnia, were posted on ClinicalTrials.gov on 2025-12-02. The study, which enrolled 20 participants, reported a mean reduction of 8.78 units on the Children's Sleep Habits Questionnaire (CSHQ) for the intervention group.
Background
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by challenges in social interaction, communication, and repetitive behaviors. Insomnia and other sleep disturbances are highly prevalent among children with ASD, significantly impacting their development, behavior, and overall family quality of life. Effective sleep health care is crucial for this population, but access to specialized behavioral sleep interventions can be limited. This study aimed to explore the feasibility and effectiveness of an innovative, scalable online delivery strategy for improving sleep in preschool-aged children with ASD.
Trial design
This completed study, designated as Phase NA, enrolled 20 participants with conditions including Autism Spectrum Disorder and Insomnia. The trial investigated an online adaptation of existing behavioral sleep interventions for preschool-aged children. Participants were assigned to either the SweetDreams intervention group or a Waitlist Control group to assess changes in sleep habits and quality.
Key results
The trial reported key measurements related to changes in sleep habits and quality:
- Change in Children's Sleep Habits Questionnaire (CSHQ) (units on a scale):
- For the SweetDreams group, the mean change was -8.78 (Standard Deviation 12.3).
- For the Waitlist Control group, the mean change was -0.59 (Standard Deviation 12.7).
- Change in Pittsburgh Sleep Quality Index (PSQI) (units on a scale):
- For the SweetDreams group, the mean change was -3.36 (Standard Deviation 4.17).
- For the Waitlist Control group, the mean change was 0.24 (Standard Deviation 3.99).
What this means
The results indicate that the SweetDreams online behavioral sleep intervention led to improvements in sleep habits and quality for preschool-aged children with Autism Spectrum Disorder and Insomnia. The intervention group showed a notable decrease in CSHQ and PSQI scores, suggesting better sleep, in contrast to the minimal change observed in the waitlist control group. These preliminary data support the potential of online, scalable strategies to address sleep challenges in this vulnerable population, offering a promising direction for improving access to care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04452045, titled "SweetDreams Sleep Study for Children With Autism", were posted on 2025-12-02 on clinicaltrials.gov.