Differences in Rest, Emotion, and Arousal Modulation in Youth

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.

Nightly emotion dysregulation

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).

Bedtime sensory over-responsivity

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).

Sleep onset latency

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.