AutismDREAMY-AutismNCT07476937
Differences in Rest, Emotion, and Arousal Modulation in Youth
A study testing Power Down bedtime manipulation in people with Autism and Sleep Disturbances in Children, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Autism, Sleep Disturbances in Children, Sleep
- What is being tested?
- Power Down bedtime manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth between the ages of 6 and 10 years old
- Caregiver-reported autism diagnosis and >11 on Social Communication Questionnaire
- Caregiver-reported bedtime resistance (>12 on Children's Sleep Habits Questionnaire-Autism; Sleep Initiation subscale - 3-point scale, 6 questions)
- Caregiver willing to participate in all bedtimes during study
- Stable medication use (e.g., no changes within 2 weeks)
Who cannot join
- Participants will be excluded if they do not understand English or are unable to travel to the lab (Pittsburgh, PA).
- Concurrent diagnosis of sleep apnea, narcolepsy, or major psychiatric disorder (e.g., major depression, bipolar).
- Unstable medication use (dose or timing).
- Current behavioral treatment for sleep disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Amy G Hartman, PhD, OTR/L, 412-648-7997, agh38@pitt.edu
About this study
Official title: Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth
The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.
Read the detailed description
This study is a cross-sectional study with a pilot pre-post intervention trial with a subset of participants. A total of 60 autistic children and caregivers will be recruited to complete questionnaires, one lab visit during which sensory responsivity to standardized sensory stimuli will be measured, and two weeks home-based data collection using daily diaries and actigraphy devices (both caregiver and child).
In a subset of 30 participants with elevated sensory over-responsivity and bedtime resistance, participants will be invited to complete the second part of the study- a open pilot study. These participants will complete a baseline interview and a lab-based training session to learn the caregiver-mediated Power Down protocol. The Power Down protocol is a standardized gentle pressure massage with a mindfulness script that aims to decrease autonomic arousal through proprioception and tactile input. Caregivers will complete the Power Down and a home-based data collection protocol for 2 weeks. During this time, caregivers and child will also wear actigraphy devices and complete daily diaries. Upon completion of the study, participants will complete exit questionnaires and an exit interview.
- Conditions
- Autism, Sleep Disturbances in Children, Sleep
- Being tested
- Power Down bedtime manipulation
- Keywords
- Sleep disturbances, Emotion Dysregulation, Sensory Processing, Sleep, autism
- Medical subject headings
- Autistic Disorder, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Down bedtime manipulationBehavioural
The Power Down is a bedtime manipulation protocol targeting elevated arousal level at bedtime due to a hypothesized effect of sensory over-responsivity (a common experience for autistic children). The Power Down incorporates sensory-based input (caregiver massage) to support nervous system regulation prior to attempting sleep onset. Participants (caregivers and their child) will be educated in the Power Down protocol and data collection methods for the 2 week intervention trial. Caregivers will lead a nightly gentle massage with guided relaxation script just prior to the child trying to fall asleep. The child will also wear a watch-like activity monitor for the 2 week period throughout the day and night to measure changes in sleep and activity patterns. Caregivers will complete daily diary questions in the morning and evening reporting their child's emotions and sleep timing.
| Study group | Role | What they receive |
|---|---|---|
| Power Down Pilot study | Experimental | 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. Receives: Behavioral: Power Down bedtime manipulation |
| No intervention group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightly emotion dysregulation
Average of nightly questions related to bedtime emotion dysregulation, based on Emotion Dysregulation Inventory short form, presented through the nightly sleep diary. The Emotion Dysregulation Inventory short form is 13 questions and scaled using a 5-point scale of "very severe" to "not at all" with higher scores indicating higher endorsement of each item. Average nightly scores range from 1-5. Measured across baseline (2 weeks) and intervention period (2 weeks).
Measured: 4 weeks
Bedtime sensory over-responsivity
Average of nightly question within the sleep diary related to child's sensory over-responsivity behaviors during bedtime on a scale of 0-100 where larger number indicates more evidence of sensory over-responsivity, 50 indicates typical response, and lower numbers indicate less evidence of sensory over-responsivity. Averages will be collected nightly across baseline (2 weeks) and during the intervention period (2 weeks).
Measured: 4 weeks
Sleep onset latency
Using reported "start of settling down" from daily sleep diaries and data from the actigraphy watch, sleep onset latency will be calculated and assessed for the child across the 2 week baseline and 2 week intervention period.
Measured: 4 weeks
Secondary outcomes (4)
Sleep efficiency
Change in sleep efficiency (calculated as a ratio of total sleep time to duration of sleep episode) between baseline and during intervention period
Measured: 4 weeks
Sleep fragmentation index
Change in sleep fragmentation index (measure of interruptions or movement during a nocturnal sleep period and is a proxy for restful sleep) calculated using data from the actigraphy watch across baseline and intervention periods.
Measured: 4 weeks
Sensory Processing
Caregivers will complete the Sensory Profile-2 at baseline and after the completion of the intervention period. The Sensory Profile-2 includes a total of 86 caregiver-reported questions on a scale of 0 (Does not Apply) to 5 (Almost Always applies) with higher scores indicating more frequent or intense sensory responses. Total scores are broken into quadrants (Seeking, Avoiding, Sensitivity, or Registration) or Sensory and Behavioral sections. Change in sensory processing by quadrant scores, which range from 0 to 95-110, will be examined.
Measured: 4 weeks
Emotion Dysregulation Inventory
Caregivers will complete the Emotion Dysregulation Inventory at baseline and after the intervention period. The Emotion Dysregulation Inventory is a 13 item, caregiver reported survey that is separated into two subsections: Reactivity and Dysphoria. Questions are answered on a scale of 0 (Not at all) to 4 (Very Severe) with higher scores indicating higher endorsement of reactivity or dysphoria. The total score of the Reactivity subsection ranges from 0-35 and the Dysphoria subsection total score ranges from 0-30. Change in both subsections will be assessed.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start20 Jul 2026
- Primary completionJul 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pilot, non-blinded intervention trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Amy Hartman, University of Pittsburgh
- Investigators
- Amy G Hartman, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476937
- Sponsor's protocol ID
- STUDY25070165
- Other IDs
- K23HD119249
- Acronym
- DREAMY-Autism
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol and informed consent forms will be shared with interested researchers upon request. Only aggregate and de-identified data collected throughout the clinical trial will be shared.