Autism Spectrum Disorder Clinical Trials

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Probing the Role of Sensory Regulation in Sleep Health and Emotion Dysregulation for Autistic Youth

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 10
Healthy Volunteers: f
View:

• 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

• Stable medication use (e.g., no changes within 2 weeks)

Locations
United States
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Amy G Hartman, PhD
agh38@pitt.edu
412-648-7997
Backup
Tracey Y Murray, BS
TYM2@pitt.edu
412-624-3961
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2030-08
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Pittsburgh
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov