Differences in Rest, Emotion, and Arousal Modulation in Youth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
Power Down bedtime manipulation
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Power Down Pilot studyExperimental treatment 1 intervention
Group B: No intervention groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
4 weeks2
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).
Time frame
4 weeks3
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.
Time frame
4 weeksSecondary outcomes
1
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
Time frame
4 weeks2
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.
Time frame
4 weeks3
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.
Time frame
4 weeks4
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.
Time frame
4 weeksSponsors and contacts
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University of Pittsburgh
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov