Differences in Rest, Emotion, and Arousal Modulation in Youth

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07476937
Status
Recruiting
Apply to this trial

Conditions

  • Autism
  • Sleep
  • Sleep Disturbances in Children

Eligibility Criteria

Sex
ALL
Age
6 Years - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • Power Down bedtime manipulation — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Jul 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Nightly emotion dysregulation [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIP
University of PittsburghPittsburghPennsylvania15219

Find similar trials in Pittsburgh, PA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University of Pittsburgh· Pittsburgh, PA

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