University of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Location status: Recruiting
NCT Number: NCT07476937
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.
Interested in participating?
Request Info6 year–10 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15219, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 4 weeks
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).
Time frame: 4 weeks
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).
Time frame: 4 weeks
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.
Time frame: 4 weeks
Change in sleep efficiency (calculated as a ratio of total sleep time to duration of sleep episode) between baseline and during intervention period
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Contact information is provided by the study sponsor or research team.
Amy G Hartman, PhD
CONTACT
Tracey Y Murray, BS
CONTACT
University of Pittsburgh
Other
Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth
Acronym: DREAMY-Autism
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06386029
Autism, Autism Spectrum Disorder
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT01322022
Autism, Autism Spectrum Disorder
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT06081348
22Q11 Deletion, 22q11 Deletion Syndrome
Calgary, Alberta, Canada
View Trial DetailsNCT07708246
Autism, Autism Spectrum Disorder
Shanghai, Shanghai Municipality, China
View Trial Details