Recruiting

Power Down

Sponsor:

University of Pittsburgh

Code:

NCT06386029

Conditions

Autism

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

Interventions

Power Down bedtime manipulation

Study Details

Brief summary:

The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:

1. Is the Power Down feasible for caregivers to do each night?
2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?

Conditions

Autism

Sleep Disturbance

Study ID

NCT06386029

Start date

Jul 5, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Child between the ages of 6 and 10 years old (at least 40%, no more than 60% female)
2. Parent-reported autism diagnosis for child
3. Parent-reported extended and problematic settling down delay
4. Parent-reported sensory over-responsivity (a "yes" to at least 8 items in the sensory screening section of the checklist)
5. Parent willing to participate in nightly routine during the 2 week study
6. Located within the Pittsburgh area

Exclusion Criteria:

1. Participants will be excluded if they do not understand English or are unable to travel to University of Pittsburgh Medical Center Western Psychiatric Hospital.
2. Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded.
3. If a child spends bedtime at a different caregiver's home for >50% of the nights and that caregiver is not willing to participate in this study, the child will be excluded from this study.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Power Down pilot arm

All participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing.

Interventions

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 tools (gentle tactile pressure and auditory cues) 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 (ActiGraph GT9x) 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.

Primary outcome measure

  • Recruitment rates of participants through the trial [ Time Frame: 1 year ]
  • Retention rates of participants through the trial [ Time Frame: 2 weeks ]
  • Caregiver reported acceptability [ Time Frame: Taken at end of 2-week intervention trial ]

Central Contacts and Locations

Central contacts

Amy G Hartman, PhD

412-648-7997agh38@pitt.edu

Adriane M Soehner, PhD

412-246-6690soehneram2@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Amy G Hartman, PhD

412-648-7997agh38@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Sleep disturbances
  • Emotion Dysregulation
  • Sensory Processing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-08-14.