Bedtime Manipulation for Autism
(DREAMY-Autism Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how sensory issues and bedtime arousal affect sleep and emotions in autistic children. Children with high sensory responses will try a new bedtime routine called "Power Down" to help them relax at night. This routine involves wearing a special watch and maintaining a sleep and emotion diary for two weeks. The trial seeks children aged 6-10 with autism, bedtime struggles, and a stable medication routine. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving bedtime routines for autistic children.
Will I have to stop taking my current medications?
You can continue taking your current medications as long as they have been stable for at least two weeks before the study starts.
What prior data suggests that the Power Down bedtime manipulation is safe for autistic children?
Research has shown that the "Power Down" bedtime routine is being studied to help autistic children sleep better. This approach emphasizes a calming bedtime routine to help children relax and fall asleep more easily.
Although specific safety data is not available, this method does not involve medication, which generally enhances its safety. It focuses on changing bedtime habits rather than introducing new substances.
The trial is labeled as "Not Applicable" in terms of phases, indicating that the safety of the treatment is still under study. However, as a behavioral approach, it is likely well-tolerated. The emphasis is on adjusting bedtime activities, which is usually considered a low-risk way to help children with autism improve their sleep.12345Why are researchers excited about this trial?
Researchers are excited about the "Power Down" bedtime manipulation trial because it explores a new approach to managing autism-related sleep disturbances. Unlike typical treatments, which often involve medication or behavioral therapy, this trial focuses on adjusting bedtime routines to improve sleep and emotional regulation. The study uses actigraphy watches to gather detailed sleep data, allowing for a more precise understanding of how bedtime routines impact children with autism. By potentially offering a non-pharmacological intervention, this trial aims to provide an accessible and side-effect-free option for families.
What evidence suggests that the Power Down bedtime manipulation is effective for autism?
Research shows that the "Power Down" bedtime routine, tested in this trial, may help autistic children fall asleep more easily. Studies have found that similar bedtime routines can help children sleep longer and fall asleep faster. Other research suggests that reducing anxiety can lessen sleep problems in autistic children. Additionally, behavioral sleep methods have successfully addressed issues like frequent night awakenings and difficulty falling asleep. These findings suggest that "Power Down" could improve sleep for children with autism by easing bedtime and calming nighttime anxiety.12678
Who Is on the Research Team?
Amy G Hartman, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for children ages 6-10 with autism who have trouble falling asleep at bedtime. They must be on stable medication, not currently in behavioral sleep therapy, and able to attend sessions in Pittsburgh. Children with major psychiatric disorders or certain sleep conditions like apnea or narcolepsy cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete questionnaires, a lab visit for sensory responsivity measurement, and two weeks of home-based data collection using daily diaries and actigraphy devices.
Intervention
In a subset of participants, the Power Down protocol is implemented, involving a baseline interview, lab-based training session, and two weeks of caregiver-mediated intervention with daily diaries and actigraphy.
Follow-up
Participants complete exit questionnaires and interviews to assess changes in sensory processing and emotion dysregulation.
What Are the Treatments Tested in This Trial?
Interventions
- Power Down bedtime manipulation
Trial Overview
The study tests a sensory-based 'Power Down' bedtime routine designed to help autistic children relax before bed. It looks at how this affects their arousal levels, sleep quality, and daytime emotions compared to usual routines.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
After consent, participants will complete an in-person lab-based sensory responsivity protocol which measures the child's responsivity to standardized sensory stimuli. Questionnaires and training on the home-based data collection protocol will also be completed. A short interview or survey regarding the lab-based protocol will be completed. After the lab visit, the child and caregiver will wear an actigraphy watch and complete daily diaries about sleep and emotion for two weeks. Upon the completion of these two weeks, the participants will return to the lab to be trained in the Power Down Protocol. Then the child and caregiver will engage in a 2-week intervention trial. Upon completion, participants will complete exit questionnaires and interviews.
After consent, participants will complete an in-person lab-based sensory responsivity protocol which measures the child's responsivity to standardized sensory stimuli. Questionnaires and training on the home-based data collection protocol will also be completed. A short interview or survey regarding the lab-based protocol will be completed. After the lab visit, the child and caregiver will wear an actigraphy watch and complete daily diaries about sleep and emotion for two weeks. Upon the completion of these two weeks, the actigraphy watches are returned and final questionnaires are completed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Digital and telehealth behavioral sleep interventions for ...
This systematic review examined the effectiveness in a hybrid telehealth model for adolescents with autism spectrum disorder (ASD), exploring ...
Parent-Implemented Bedtime Fading and Positive Routines ...
Results suggest some efficacy for both interventions. Increased total sleep duration and decreased sleep onset latency were achieved with bedtime fading.
3.
trialx.com
trialx.com/clinical-trials/listings/309460/the-power-down-pilot-study-a-novel-bedtime-manipulation-protocol/The Power Down Pilot Study: A Novel Bedtime ...
Overview. The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol ...
Bedtime Routine for Autism
This trial explores a new bedtime routine, "The Power Down," designed to help autistic children aged 6-10 settle down and fall asleep more easily.
Sleep disturbances in autism spectrum disorder
The sleep problems in children with ASD were shown to be decreased when their anxiety, as reported by the parents, was low (Fletcher et al., 2017). Furthermore, ...
Sleep in Children with Autism Spectrum Disorder - PMC - NIH
Currently, there are no Food and Drug Administration (FDA) approved medications for sleep problems in children with ASD, but off-label medication use is common.
Beyond challenging behaviors, sleep maintenance ...
Autistic children are at increased risk for psychiatric hospitalization for challenging behaviors. Sleep problems may increase this risk due to the added ...
Bedtime Fading with Response Cost for Treatment of Sleep ...
As many as 82% of children with Autism Spectrum Disorders (ASD) experience numerous chronic sleep-related problems and at a much higher frequency and severity.
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