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The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol

ConditionsAutismSleep Disturbance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-10
SponsorUniversity of Pittsburgh

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Power Down pilot armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year
2

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.

Time frame
2 weeks
3

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).

Time frame
Taken at end of 2-week intervention trial

Secondary outcomes

1

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.

Time frame
During 2 week trial
2

Data collection rates- Questionnaires

We will measure completion rates of questionnaires as a secondary measure of feasibility. Benchmark: \>75% of questionnaires will be completed

Time frame
At baseline
3

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

Time frame
2 weeks
4

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)

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

Source ClinicalTrials.gov
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