Clinical trial NCT06386029: The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol
Official title: Powering Down: A Pilot Study of a Bedtime Manipulation to Support Sleep for Autistic Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism
Sleep Disturbance
Keywords: Sleep disturbances
Emotion Dysregulation
Sensory Processing
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot, non-blinded intervention trial
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rates of participants through the trial
timeFrame: 1 year
measure: Retention rates of participants through the trial
timeFrame: 2 weeks
measure: Caregiver reported acceptability
timeFrame: Taken at end of 2-week intervention trial
Secondary outcomes:
measure: Treatment adherence
timeFrame: During 2 week trial
measure: Data collection rates- Questionnaires
timeFrame: At baseline
measure: Data collection rates- Daily diaries
timeFrame: 2 weeks
measure: Data collection rates- Wearing the actigraphy watch
timeFrame: 2 weeks
measure: Credibility/Expectancy Questionnaire
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Amy G Hartman, PhD
role: PRINCIPAL_INVESTIGATOR
References: