AutismNCT06386029
The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol
A study testing Power Down bedtime manipulation in people with Autism and Sleep Disturbance, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Autism, Sleep Disturbance
- What is being tested?
- Power Down bedtime manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Amy G Hartman, PhD, 412-648-7997, agh38@pitt.edu
About this study
Official title: Powering Down: A Pilot Study of a Bedtime Manipulation to Support Sleep for Autistic Children
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:
- Is the Power Down feasible for caregivers to do each night?
- Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?
Read the detailed description
Interested participants will contact the research team and complete screening to determine eligibility (see Screener document). For eligible participants, the informed consent form will be sent and a consent call or video call will be scheduled. The study team will complete the consent process with eligible caregivers (on phone or via video call) and a consent form will be sent via DocuSign for the caregiver to sign.
Following the consent process, questionnaires (below) will be sent via REDCap to complete and a in-lab training meeting will be scheduled. During the in-lab training meeting, the PI (Hartman) will complete the bedtime manipulation training (details found in the Power Down Protocol document found in the Basic Study Information section of this IRB). After the education training, the caregiver(s) will be instructed in the "Power Down massage" and they will practice with their child in the lab and receive feedback on their delivery of the massage. The caregiver(s) and their child will also be given an activity monitor and instructed on the use and care of the device. The caregiver(s) will also review the morning and evening diaries to be completed throughout the study with a study team member.
Following the training session, the caregiver(s) and their child will complete the power down massage nightly, just prior to the time the child would start to try to fall asleep (e.g., after caregiver says "good night", when caregiver leaves the room), for two weeks. They will also complete a morning and evening diary entry, which will be sent virtually. At the end of the two weeks, the activity monitor will be returned to the study team. The participants will connect with the study team to complete an exit interview about their participation in the study and questionnaires about the treatment acceptability.
- Conditions
- Autism, Sleep Disturbance
- Being tested
- Power Down bedtime manipulation
- Keywords
- Sleep disturbances, Emotion Dysregulation, Sensory Processing
- Medical subject headings
- Autistic Disorder, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Down bedtime manipulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Power Down pilot arm | Experimental | All participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing. Receives: Behavioral: Power Down bedtime manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: Taken at end of 2-week intervention trial
Secondary outcomes (5)
Treatment adherence
As a secondary measure of feasibility, caregiver reported rates of treatment adherence will be measured. Caregivers will report completing the Power Down massage at least 10/14 nights during the 2 week intervention.
Measured: During 2 week trial
Data collection rates- Questionnaires
We will measure completion rates of questionnaires as a secondary measure of feasibility.
Benchmark:
>75% of questionnaires will be completed
Measured: At baseline
Data collection rates- Daily diaries
We will measure completion rates of the number of daily diaries completed as a secondary measure of feasibility.
Benchmark: >75% of daily diaries will be completed
Measured: 2 weeks
Data collection rates- Wearing the actigraphy watch
We will measure the amount of days/nights children wore the actigraphy watch as a secondary measure of feasibility.
Benchmarks: Children will tolerate wearing watch for at least 10/14 nights (6+ hours during their reported sleeping times)
Measured: 2 weeks
Credibility/Expectancy Questionnaire
We will gather information about the caregiver's perceived credibility (questions 1-3, Set 1) and expectations (question 4 Set 1, questions 1-2 Set 2) related to the intervention at baseline and at the end of the intervention. Each question is rated on a 9-point scale, with 1 being "do not agree at all" and 9 being "strongly agree).
Benchmark:
At both baseline and post-intervention, caregivers will rate the intervention an average of 6 (on a 9 point scale) for both credibility and expectations, indicating more than somewhat confident.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start5 Jul 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot, non-blinded intervention trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Hartman, PhD, OTR/L, University of Pittsburgh
- Investigators
- Amy G Hartman, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386029
- Sponsor's protocol ID
- STUDY24010191
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full study protocol and informed consent forms will be shared with interested researchers upon request. Only aggregate and de-identified data collected throughout the clinical trial will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Powering Down: A Pilot Study of a Bedtime Manipulation to Support Sleep for Autistic Children
- ClinicalTrials.gov ID
- NCT06386029
- Acronym / sponsor ID
- STUDY24010191
- Conditions
- Autism, Sleep Disturbance
- Keywords
- Sleep disturbances, Emotion Dysregulation, Sensory Processing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the Power Down feasible for caregivers to do each night?
- Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?
Detailed description
Interested participants will contact the research team and complete screening to determine eligibility (see Screener document). For eligible participants, the informed consent form will be sent and a consent call or video call will be scheduled. The study team will complete the consent process with eligible caregivers (on phone or via video call) and a consent form will be sent via DocuSign for the caregiver to sign.
Following the consent process, questionnaires (below) will be sent via REDCap to complete and a in-lab training meeting will be scheduled. During the in-lab training meeting, the PI (Hartman) will complete the bedtime manipulation training (details found in the Power Down Protocol document found in the Basic Study Information section of this IRB). After the education training, the caregiver(s) will be instructed in the "Power Down massage" and they will practice with their child in the lab and receive feedback on their delivery of the massage. The caregiver(s) and their child will also be given an activity monitor and instructed on the use and care of the device. The caregiver(s) will also review the morning and evening diaries to be completed throughout the study with a study team member.
Following the training session, the caregiver(s) and their child will complete the power down massage nightly, just prior to the time the child would start to try to fall asleep (e.g., after caregiver says "good night", when caregiver leaves the room), for two weeks. They will also complete a morning and evening diary entry, which will be sent virtually. At the end of the two weeks, the activity monitor will be returned to the study team. The participants will connect with the study team to complete an exit interview about their participation in the study and questionnaires about the treatment acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot, non-blinded intervention trial
| Arm | Type | Receives |
|---|---|---|
| Power Down pilot arm | Experimental | Behavioral: Power Down bedtime manipulationAll participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power Down bedtime manipulationThe 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. | Behavioural | Power Down pilot arm |
Primary outcome
Recruitment rates of participants through the trial
Time frame: 1 year
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
Retention rates of participants through the trial
Time frame: 2 weeks
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.
Caregiver reported acceptability
Time frame: Taken at end of 2-week intervention trial
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).
5 secondary outcomes
Treatment adherence
Time frame: During 2 week trial
Data collection rates- Questionnaires
Time frame: At baseline
Data collection rates- Daily diaries
Time frame: 2 weeks
Data collection rates- Wearing the actigraphy watch
Time frame: 2 weeks
Credibility/Expectancy Questionnaire
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. The full study protocol and informed consent forms will be shared with interested researchers upon request. Only aggregate and de-identified data collected throughout the clinical trial will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy G Hartman, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Down bedtime manipulation in people with Autism and Sleep Disturbance, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy G Hartman, PhD (412-648-7997, agh38@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates of participants through the trial (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.