Differences in Rest, Emotion, and Arousal Modulation in Youth

NCT07476937 | Recruiting

• 2 other identifiers: STUDY25070165K23HD119249
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Sleep; Sleep Disturbances in Children

Keywords

Sleep disturbances; Emotion Dysregulation; Sensory Processing; Sleep; autism

Outcome Measures

Primary Outcomes (3)

• 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).

  4 weeks

• 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).

  4 weeks

• 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.

  4 weeks

Secondary Outcomes (4)

• Sleep efficiency

  4 weeks

• Sleep fragmentation index

  4 weeks

• Sensory Processing

  4 weeks

• Emotion Dysregulation Inventory

  4 weeks

Study Arms (2)

Power Down Pilot study

EXPERIMENTAL

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.

Behavioral: Power Down bedtime manipulation

No intervention group

NO INTERVENTION

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.

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.

Power Down Pilot study

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Parasomnias

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Amy G Hartman, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy G Hartman, PhD

CONTACT

412-648-7997; agh38@pitt.edu

Tracey Y Murray, BS

CONTACT

412-624-3961; TYM2@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot, non-blinded intervention trial

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available to share after publication of findings or 5 years after the end of the study, whichever comes first.
• Access Criteria: Data will be shared with researchers within and outside of the University of Pittsburgh through email requests to the lead principal investigator. The University of Pittsburgh may require a data use agreement be developed and signed by both institutions.

Locations

US (1)