Autism, Sleep, Sleep Disturbances in Children
Conditions
Keywords
Sleep disturbances, Emotion Dysregulation, Sensory Processing, Sleep, autism
Brief 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). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.
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.
Interventions
BEHAVIORALPower 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.
Sponsors
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot, non-blinded intervention trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nightly emotion dysregulation | 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). |
| Bedtime sensory over-responsivity | 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). |
| Sleep onset latency | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | 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 |
| Sleep fragmentation index | 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. |
| Sensory Processing | 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. |
| Emotion Dysregulation Inventory | 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. |
Countries
United States
Contacts
CONTACTAmy G Hartman, PhD
CONTACTTracey Y Murray, BS
PRINCIPAL_INVESTIGATORAmy G Hartman, PhD
University of Pittsburgh
Outcome results
None listed