RECRUITING

The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol

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Conditions

AutismSleep DisturbanceSleep disturbancesEmotion DysregulationSensory Processing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Powering Down: A Pilot Study of a Bedtime Manipulation to Support Sleep for Autistic Children

Quick Facts

Study Start:2025-07-05
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06386029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 10 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Child between the ages of 6 and 10 years old (at least 40%, no more than 60% female)
  2. 2. Parent-reported autism diagnosis for child
  3. 3. Parent-reported extended and problematic settling down delay
  4. 4. Parent-reported sensory over-responsivity (a "yes" to at least 8 items in the sensory screening section of the checklist)
  5. 5. Parent willing to participate in nightly routine during the 2 week study
  6. 6. Located within the Pittsburgh area
  1. 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. 2. Children who have trauma or other histories for whom physical touch is triggering (per caregiver report) will be excluded.
  3. 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.

Contacts and Locations

Study Contact

Amy G Hartman, PhD
CONTACT
412-648-7997
agh38@pitt.edu
Adriane M Soehner, PhD
CONTACT
412-246-6690
soehneram2@upmc.edu

Principal Investigator

Amy G Hartman, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Amy G Hartman, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-05
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-07-05
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Sleep disturbances
  • Emotion Dysregulation
  • Sensory Processing

Additional Relevant MeSH Terms

  • Autism
  • Sleep Disturbance