The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol

NCT06386029 | Recruiting

• 1 other identifier: STUDY24010191
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.Is the Power Down feasible for caregivers to do each night?
2. 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

Keywords

Sleep disturbances; Emotion Dysregulation; Sensory Processing

Outcome Measures

Primary Outcomes (3)

• Recruitment rates of participants through the trial

  We will use recruitment rates as one of our primary measure of feasibility of this protocol. Benchmark include: Recruitment rates: \>2 caregiver-child dyads enrolled per month

  1 year

• Retention rates of participants through the trial

  We will use retention rates as one of our primary measure of feasibility of this protocol. Benchmarks include: Retention rates: \>80% of consented dyads will complete at least 10 nights of the Power Down during the 2 week intervention trial.

  2 weeks

• Caregiver reported acceptability

  During the exit interview, caregivers will be asked "Is this intervention an acceptable option for families who are experiencing bedtime difficulties" as a primary measure of acceptability. \>80% of enrolled participants who completed at least 4 days of the Power Down manipulation will report that the intervention is an acceptable option for families like theirs who are experiencing bedtime difficulties (question on post-intervention questions).

  Taken at end of 2-week intervention trial

Secondary Outcomes (5)

• Treatment adherence

  During 2 week trial

• Data collection rates- Questionnaires

  At baseline

• Data collection rates- Daily diaries

  2 weeks

• Data collection rates- Wearing the actigraphy watch

  2 weeks

• Credibility/Expectancy Questionnaire

  2 weeks

Study Arms (1)

Power Down pilot arm

EXPERIMENTAL

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

Behavioral: Power Down bedtime manipulation

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 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.

Power Down pilot arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Participants will be excluded if they do not understand English or are unable to travel to University of Pittsburgh Medical Center Western Psychiatric Hospital.
• Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded.
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, 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

Adriane M Soehner, PhD

CONTACT

412-246-6690; soehneram2@upmc.edu

Study Design

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

Model Details: Pilot, non-blinded intervention trial

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 26, 2024
• Study Start: July 5, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available to share after publication of findings or 2 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)