Differences in Rest, Emotion, and Arousal Modulation in Youth (DREAMY-Autism)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Autism; Sleep Disturbances in Children
• Intervention / Treatment: Behavioral: Power Down bedtime manipulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy G Hartman, PhD; Phone Number: 412-648-7997; Email: agh38@pitt.edu
• Study Contact Backup: Name: Tracey Y Murray, BS; Phone Number: 412-624-3961; Email: TYM2@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • Recruiting
      • University of Pittsburgh
      • Contact: Amy G Hartman, PhD, OTR/L; Phone Number: 412-648-7997; Email: agh38@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Youth between the ages of 6 and 10 years old
2. Caregiver-reported autism diagnosis and >11 on Social Communication Questionnaire
3. Caregiver-reported bedtime resistance (>12 on Children's Sleep Habits Questionnaire-Autism; Sleep Initiation subscale - 3-point scale, 6 questions)
4. Caregiver willing to participate in all bedtimes during study
5. Stable medication use (e.g., no changes within 2 weeks)

Exclusion Criteria:

1. Participants will be excluded if they do not understand English or are unable to travel to the lab (Pittsburgh, PA).
2. Concurrent diagnosis of sleep apnea, narcolepsy, or major psychiatric disorder (e.g., major depression, bipolar).
3. Unstable medication use (dose or timing).
4. Current behavioral treatment for sleep disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Power Down Pilot study; 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.	Behavioral: Power Down bedtime manipulation; 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.
No Intervention: No intervention group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 weeks
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).	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	4 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Amy G Hartman, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: autism; Sleep; Sleep disturbances; Emotion Dysregulation; Sensory Processing
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Parasomnias; Autistic Disorder
• Other Study ID Numbers: STUDY25070165; K23HD119249 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available to share after publication of findings or 5 years after the end of the study, whichever comes first.
• IPD Sharing Access Criteria: Data will be shared with researchers within and outside of the University of Pittsburgh through email requests to the lead principal investigator. The University of Pittsburgh may require a data use agreement be developed and signed by both institutions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No