The Power Down Pilot Study: a Novel Bedtime Manipulation Protocol

Not Applicable

Not yet recruiting

• Conditions: Sleep Disturbance; Autism
• Interventions: Behavioral: Power Down bedtime manipulation

• Registration Number: NCT06386029
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27
• Study Start: 2025-04
• Primary Completion: 2026-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Power Down pilot arm	Power Down bedtime manipulation	All participants will engage in a 2-week pilot intervention trial with baseline and post-intervention testing.

Primary Outcome Measures

Name	Time	Method
Retention rates of participants through the trial	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	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).
Recruitment rates of participants through the trial	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

Secondary Outcome Measures

Name	Time	Method
Data collection rates- Wearing the actigraphy watch	2 weeks	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)
Data collection rates- Questionnaires	At baseline	We will measure completion rates of questionnaires as a secondary measure of feasibility.; Benchmark: \>75% of questionnaires will be completed
Treatment adherence	During 2 week trial	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.
Data collection rates- Daily diaries	2 weeks	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
Credibility/Expectancy Questionnaire	2 weeks	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States