Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386029
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-12
Brief Title:
The Power Down Pilot Study a Novel Bedtime Manipulation Protocol
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Powering Down a Pilot Study of a Bedtime Manipulation to Support Sleep for Autistic Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs difficulties settling down to fall asleep
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 childs 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 caregivers 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 caregivers and their child will also be given an activity monitor and instructed on the use and care of the device The caregivers will also review the morning and evening diaries to be completed throughout the study with a study team member
Following the training session the caregivers and their child will complete the power down massage nightly just prior to the time the child would start to try to fall asleep eg 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
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 caregivers 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 caregivers and their child will also be given an activity monitor and instructed on the use and care of the device The caregivers will also review the morning and evening diaries to be completed throughout the study with a study team member
Following the training session the caregivers and their child will complete the power down massage nightly just prior to the time the child would start to try to fall asleep eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None